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Types of research questions

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Literature Searching

Types of Research Questions

Research questions can be categorized into different types, depending on the type of research to be undertaken.

Qualitative questions concern broad areas or more specific areas of research and focus on discovering, explaining and exploring.  Types of qualitative questions include:

• Exploratory Questions, which seeks to understand without influencing the results.  The objective is to learn more about a topic without bias or preconceived notions.
• Predictive Questions, which seek to understand the intent or future outcome around a topic.
• Interpretive Questions, which tries to understand people’s behavior in a natural setting.  The objective is to understand how a group makes sense of shared experiences with regards to various phenomena.

Quantitative questions prove or disprove a  researcher’s hypothesis and are constructed to express the relationship between variables  and whether this relationship is significant.  Types of quantitative questions include:

• Descriptive questions , which are the most basic type of quantitative research question and seeks to explain the when, where, why or how something occurred. 
• Comparative questions are helpful when studying groups with dependent variables where one variable is compared with another.
• Relationship-based questions try to answer whether or not one variable has an influence on another.  These types of question are generally used in experimental research questions.

References/Additional Resources

Lipowski, E. E. (2008). Developing great research questions . American Journal of Health-System Pharmacy, 65(17), 1667–1670.

Ratan, S. K., Anand, T., & Ratan, J. (2019). Formulation of Research Question - Stepwise Approach .  Journal of Indian Association of Pediatric Surgeons ,  24 (1), 15–20.

Fandino W.(2019). Formulating a good research question: Pearls and pitfalls . I ndian J Anaesth. 63(8) :611-616. 

Beck, L. L. (2023). The question: types of research questions and how to develop them . In Translational Surgery: Handbook for Designing and Conducting Clinical and Translational Research (pp. 111-120). Academic Press. 

Doody, O., & Bailey, M. E. (2016). Setting a research question, aim and objective. Nurse Researcher, 23(4), 19–23.

Plano Clark, V., & Badiee, M. (2010). Research questions in mixed methods research . In: SAGE Handbook of Mixed Methods in Social & Behavioral Research .  SAGE Publications, Inc.,

Agee, J. (2009). Developing qualitative research questions: A reflective process .  International journal of qualitative studies in education ,  22 (4), 431-447. 

Flemming, K., & Noyes, J. (2021). Qualitative Evidence Synthesis: Where Are We at? I nternational Journal of Qualitative Methods, 20.  

Research Question Frameworks

Research question frameworks have been designed to help structure research questions and clarify the main concepts. Not every question can fit perfectly into a framework, but using even just parts of a framework can help develop a well-defined research question. The framework to use depends on the type of question to be researched.   There are over 25 research question frameworks available.  The University of Maryland has a nice table listing out several of these research question frameworks, along with what the acronyms mean and what types of questions/disciplines that may be used for.

The process of developing a good research question involves taking your topic and breaking each aspect of it down into its component parts.

Booth, A., Noyes, J., Flemming, K., Moore, G., Tunçalp, Ö., & Shakibazadeh, E. (2019). Formulating questions to explore complex interventions within qualitative evidence synthesis.   BMJ global health ,  4 (Suppl 1), e001107. (See supplementary data#1)

The "Well-Built Clinical Question“: PICO(T)

One well-established framework that can be used both for refining questions and developing strategies is known as PICO(T). The PICO framework was designed primarily for questions that include interventions and comparisons, however other types of questions may also be able to follow its principles.  If the PICO(T) framework does not precisely fit your question, using its principles (see alternative component suggestions) can help you to think about what you want to explore even if you do not end up with a true PICO question.

A PICO(T) question has the following components:

• P : The patient’s disorder or disease or problem of interest / research object
• I: The intervention, exposure or finding under review / Application of a theory or method
• C: A comparison intervention or control (if applicable- not always present)/ Alternative theories or methods (or, in their absence, the null hypothesis)
• O : The outcome(s) (desired or of interest) / Knowledge generation
• T : (The time factor or period)

Keep in mind that solely using a tool will not enable you to design a good question. What is required is for you to think, carefully, about exactly what you want to study and precisely what you mean by each of the things that you think you want to study.

Rzany, & Bigby, M. (n.d.). Formulating Well-Built Clinical Questions. In Evidence-based dermatology / (pp. 27–30). Blackwell Pub/BMJ Books.  

Nishikawa-Pacher, A. (2022). Research questions with PICO: a universal mnemonic.   Publications ,  10 (3), 21.

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• 10 Research Question Examples to Guide Your Research Project

10 Research Question Examples to Guide your Research Project

Published on October 30, 2022 by Shona McCombes . Revised on October 19, 2023.

The research question is one of the most important parts of your research paper , thesis or dissertation . It’s important to spend some time assessing and refining your question before you get started.

The exact form of your question will depend on a few things, such as the length of your project, the type of research you’re conducting, the topic , and the research problem . However, all research questions should be focused, specific, and relevant to a timely social or scholarly issue.

Once you’ve read our guide on how to write a research question , you can use these examples to craft your own.

Note that the design of your research question can depend on what method you are pursuing. Here are a few options for qualitative, quantitative, and statistical research questions.

Other interesting articles

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

Methodology

• Sampling methods
• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

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Clarifying the review question leads to specifying what type of studies can best address that question and setting out criteria for including such studies in the review. This is often called inclusion criteria or eligibility criteria. The criteria could relate to the review topic, the research methods of the studies, specific populations, settings, date limits, geographical areas, types of interventions, or something else.

Systematic reviews address clear and answerable research questions, rather than a general topic or problem of interest. They also have clear criteria about the studies that are being used to address the research questions. This is often called inclusion criteria or eligibility criteria.

Six examples of types of question are listed below, and the examples show different questions that a review might address based on the topic of influenza vaccination. Structuring questions in this way aids thinking about the different types of research that could address each type of question. Mneumonics can help in thinking about criteria that research must fulfil to address the question. The criteria could relate to the context, research methods of the studies, specific populations, settings, date limits, geographical areas, types of interventions, or something else.

Examples of review questions

• Needs - What do people want? Example: What are the information needs of healthcare workers regarding vaccination for seasonal influenza?
• Impact or effectiveness - What is the balance of benefit and harm of a given intervention? Example: What is the effectiveness of strategies to increase vaccination coverage among healthcare workers. What is the cost effectiveness of interventions that increase immunisation coverage?
• Process or explanation - Why does it work (or not work)? How does it work (or not work)?  Example: What factors are associated with uptake of vaccinations by healthcare workers?  What factors are associated with inequities in vaccination among healthcare workers?
• Correlation - What relationships are seen between phenomena? Example: How does influenza vaccination of healthcare workers vary with morbidity and mortality among patients? (Note: correlation does not in itself indicate causation).
• Views / perspectives - What are people's experiences? Example: What are the views and experiences of healthcare workers regarding vaccination for seasonal influenza?
• Service implementation - What is happening? Example: What is known about the implementation and context of interventions to promote vaccination for seasonal influenza among healthcare workers?

Examples in practice :  Seasonal influenza vaccination of health care workers: evidence synthesis / Loreno et al. 2017

Example of eligibility criteria

Research question: What are the views and experiences of UK healthcare workers regarding vaccination for seasonal influenza?

• Population: healthcare workers, any type, including those without direct contact with patients.
• Context: seasonal influenza vaccination for healthcare workers.
• Study design: qualitative data including interviews, focus groups, ethnographic data.
• Date of publication: all.
• Country: all UK regions.
• Studies focused on influenza vaccination for general population and pandemic influenza vaccination.
• Studies using survey data with only closed questions, studies that only report quantitative data.

Consider the research boundaries

It is important to consider the reasons that the research question is being asked. Any research question has ideological and theoretical assumptions around the meanings and processes it is focused on. A systematic review should either specify definitions and boundaries around these elements at the outset, or be clear about which elements are undefined. 

For example if we are interested in the topic of homework, there are likely to be pre-conceived ideas about what is meant by 'homework'. If we want to know the impact of homework on educational attainment, we need to set boundaries on the age range of children, or how educational attainment is measured. There may also be a particular setting or contexts: type of school, country, gender, the timeframe of the literature, or the study designs of the research.

Research question: What is the impact of homework on children's educational attainment?

• Scope : Homework - Tasks set by school teachers for students to complete out of school time, in any format or setting.
• Population: children aged 5-11 years.
• Outcomes: measures of literacy or numeracy from tests administered by researchers, school or other authorities.
• Study design: Studies with a comparison control group.
• Context: OECD countries, all settings within mainstream education.
• Date Limit: 2007 onwards.
• Any context not in mainstream primary schools.
• Non-English language studies.

Mnemonics for structuring questions

Some mnemonics that sometimes help to formulate research questions, set the boundaries of question and inform a search strategy.

Intervention effects

PICO  Population – Intervention– Outcome– Comparison

Variations: add T on for time, or ‘C’ for context, or S’ for study type,

Policy and management issues

ECLIPSE : Expectation – Client group – Location – Impact ‐ Professionals involved – Service

Expectation encourages  reflection on what the information is needed for i.e. improvement, innovation or information.  Impact looks at what  you would like to achieve e.g. improve team communication .

• How CLIP became ECLIPSE: a mnemonic to assist in searching for health policy/management information / Wildridge & Bell, 2002

Analysis tool for management and organisational strategy

PESTLE:  Political – Economic – Social – Technological – Environmental ‐ Legal

An analysis tool that can be used by organizations for identifying external factors which may influence their strategic development, marketing strategies, new technologies or organisational change.

• PESTLE analysis / CIPD, 2010

Service evaluations with qualitative study designs

SPICE:  Setting (context) – Perspective– Intervention – Comparison – Evaluation

Perspective relates to users or potential users. Evaluation is how you plan to measure the success of the intervention.

• Clear and present questions: formulating questions for evidence based practice / Booth, 2006

Read more about some of the frameworks for constructing review questions:

• Formulating the Evidence Based Practice Question: A Review of the Frameworks / Davis, 2011
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Part 1. Overview Information

National Institutes of Health ( NIH )

National Eye Institute ( NEI )

National Institute on Aging ( NIA )

National Institute on Alcohol Abuse and Alcoholism ( NIAAA )

Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD )

National Institute of Dental and Craniofacial Research ( NIDCR )

National Institute on Drug Abuse ( NIDA )

National Institute of Mental Health ( NIMH )

National Institute of Neurological Disorders and Stroke ( NINDS )

National Institute of Nursing Research ( NINR )

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All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR )

R01 Research Project Grant

• NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
• NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
• October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 .
• September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181 .
• August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169
• August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
• April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109

See Section III. 3. Additional Information on Eligibility .

This funding opportunity announcement (FOA) invites research projects that seek to explain the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in human health, illness, recovery, and overall wellbeing. Types of projects submitted under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical and/or behavioral outcomes in humans to understand fundamental aspects of phenomena related to social connectedness and isolation. NIH considers such studies as Basic Experimental Studies with Humans (BESH) that are prospective basic science studies involving human participants that meet the NIH definition of basic research and fall within the NIH definition of clinical trials (see, e.g., NOT-OD-19-024 ). Applications should not propose a goal of clinical outcomes or products. Applications that propose studies including model animal research or observational studies involving humans should submit under the companion FOA, PAR-21-350 "Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Clinical Trials Not Allowed).

Not Applicable

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section i. funding opportunity description.

All applications submitted to this Funding Opportunity Announcement must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as prospective basic science studies involving human participants, that fall within the NIH definition of a clinical trial and meet the definition of basic research.

NIH defines basic research consistent with the definition of basic research in federal code, the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind ( 32 CFR 272.3 ).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes" ( NOT-OD-15-015 ).

Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

For the purposes of this FOA, specific application towards processes or products refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena may submit under this FOA.

Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate FOA for the type of study.

This funding opportunity announcement (FOA) invites research projects that seek to explain the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in human health, illness, recovery, and overall wellbeing.

Research areas of interest include understanding differences and similarities between objective social isolation and loneliness, how complex biopsychosocial processes are regulated in the body, what occurs in response to dysregulation, and antecedent processes that influence responses to the trajectories of social relationships. Studies that involve neurobiological approaches for example, how social or isolated settings influence neurobiological systems, brain function, and/or behavior are welcome. Projects designed to study how changes in the quantity and/or quality of social connections influence health behaviors and outcomes are encouraged. This FOA also encourages projects that incorporate aims to promote methods and measures needed to support a cumulative and integrated approach to the study of social connectedness and isolation.

The terms "social connection" and "social connectedness" often are used interchangeably in research. For the purposes of this FOA, "social connectedness" encompasses both perceived and actual connections to others, as well as an individual's perception of belongingness to the social environment. Researchers with questions regarding these terms should inquire with IC scientific contacts.

All applications submitted through this FOA must propose basic science experimental studies with humans, also referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies meet the NIH definition of basic research and the NIH definition of a clinical trial . Observational studies involving humans should submit under the companion Clinical Trials Not Allowed version of this FOA.

It is well-established that social ties can facilitate overall wellbeing, recovery from acute illness, and self-management of chronic conditions. Less well understood are the processes by which connection and isolation lead to positive or negative impacts on health, wellbeing, illness, or recovery. A more comprehensive understanding of the mechanisms, processes, and trajectories involved in social connectedness and isolation may identify novel targets to inform future intervention developments and to strengthen individual and group functions.

For example, the prefrontal cortex can handle multiple, yet not infinite, concurrent processes. Changes in prefrontal processing may lead individuals to adaptively self-isolate as one way to reduce external social stimulation, to protect or avoid stress, or to focus on specific cognitive tasks. Yet extended isolation can lead to negative changes in neuronal size, activity patterns, and intracellular processes that can reduce cognitive and sensory capacities and subsequent behavior.

Social media usage, such as sharing photos and videos with family members and friends, can facilitate connections and have salutary effects. Social media also can be used to publicly bully or shame others, often youth. Targets of social media abuse consequently may engage in maladaptive behaviors including aggression, delinquency, substance use and misuse, self-harm, social withdrawal, or suicidal ideation. We currently lack an understanding of the biopsychosocial processes that facilitate wellbeing among some youth who use social media but not others.

This FOA solicits research to better understand the basic individual, social, and biobehavioral processes by which social connectedness and isolation have positive or negative impacts across the lifespan. It encourages projects that explore the relationships between various factors, including those that can be objectively measured (e.g., biomeasures or data from health records, occurrence or length of relationship disruption) and those that require self-report.

The arena of social connectedness, connection, and isolation health research is relatively new, and therefore ripe for construct, theory, and measurement mapping and measurement harmonization efforts. Therefore, in addition to understanding the mechanistic relationships between aspects of social connection and isolation in health contexts, research projects in the areas such as knowledge representation and behavioral ontology development are welcomed. If appropriate, projects may use NIH-supported common data elements (CDEs), electronic health record data, and/or propose sophisticated statistical analyses of existing and/or synthesized datasets that lead to hypotheses for testing in humans or animals--though applications proposing model animal research should submit through the companion FOA mentioned above.

Research projects focused on either animal or human subjects are encouraged. Also encouraged are projects that strive to determine optimal measurement approaches across species, that validate and utilize measures across the lifespan, and that test measures in a range of clinical contexts.

This FOA solicits R01 applications that may range between 2-5 years. The R01 mechanism, common to all NIH ICOs participating in this FOA, was chosen expressly to empower investigators to propose innovative scopes of work with correspondingly appropriate budgets. Regardless of the number of project-years proposed, investigators should budget each year for travel to an annual meeting of grantees on or near the NIH Campus in Bethesda, MD, to share research methods and findings. Awardees will be encouraged to work together on some shared scientific opportunities at the annual meeting and across the award period.

Three areas of focus especially of interest to OppNet and participating NIH ICOs include, but are not limited to, those below:

1. Effects of social connectedness, connection, and isolation across the lifespan

• Affective and cognitive function during the aging process
• Caregivers of people with dementia, severe illness, end-of-life
• Chronic illness or limited mobility
• Perceived strength or quality of extant social connections
• Recent diagnosis with a serious medical illness
• Sleep changes across the lifespan (e.g. during adolescence, early parenthood, menopause)
• Impact of transitions across the lifespan (e.g., transitioning from the family home to college or elsewhere; transitioning from full-time work to retirement)
• Molecular markers and mechanisms (e.g., epigenetic modifications, gene expression, microbiome alterations, telomere attrition) associated with changes in social connectedness
• Neurobiological developmental trajectories
• (e.g., adolescence, middle-age men, people who receive a serious medical diagnosis, retirement, death of spouse/parent)
• Risky sexual activity and/or aggressive behaviors associated with connection trajectories
• Mechanisms of connectedness, connection, and isolation
• Impact on structure and function of the nervous system (central, peripheral, autonomic)
• Impact on neuroimmune and neuroendocrine systems
• Impact on neural systems associated with basic affective, cognitive, and social processes
• Importance of inter-individual neural synchrony in mediating or moderating effects in relationship trajectories
• Neurobiological biosignatures that predict sensitivity to connection disruption or isolation
• Neurobiological processes that could be targets to ameliorate negative effects of disruption or isolation
• Neuro-physiological consequences of disruption or isolation on substance use disorders (SUDs) and mental illness
• The consequences of perceived isolation (e.g., loneliness) and/or objective/observed isolation on behavioral and clinical outcomes in adolescence and adulthood
• Autism, HIV, mental illness, recovery status, substance use disorder
• Racial/ethnic differences, acculturation/bicultural adaptations and contributions to social integration versus isolation
• Sex/gender differences; sexual and gender minorities
• E.g., Self-induced isolation versus isolation by others, or sense of undesired loneliness vs. enjoyed solitude
• Knowledge representation and behavioral ontology development
• Development of clearly defined vocabularies and taxonomies
• Elucidating relationships across constructs and between constructs and measures,
• Integration of knowledge related to social connectedness, connection, and isolation into existing interoperable and shareable measures or ontology frameworks

About OppNet

OppNet is a trans-NIH initiative that funds research activities that build the collective body of knowledge on the nature of behaviors and social systems and deepen our understanding of basic social-behavioral mechanisms and processes. All OppNet initiatives invite investigators to propose research projects that will advance basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health research. All NIH Institutes and Centers that fund research and Program Coordination Offices within the NIH Office of the Director (ICOs) collectively manage OppNet's scientific direction yet may not participate in every OppNet FOA. Therefore, applicants should review the list of ICOs in this FOA's Components of Participating Organizations to ensure that a proposed research project aligns with at least one NIH IC, its mission, and its interests delineated below. For more information about OppNet, visit https://oppnet.nih.gov .

OppNet strives to ensure that proposed projects focus primarily on basic socio-behavioral and biopsychosocial sciences. Though OppNet defers from imposing a definition on the field, OppNet uses the following statement to guide the concepts it develops toward funding opportunity announcements: basic behavioral and social sciences research (b-BSSR) furthers our understanding of fundamental mechanisms and patterns of behavioral and social functioning, relevant to the Nation's health and wellbeing, and as they interact with each other, with biology, and with the environment. OppNet acknowledges that disease-, risk-, and wellness-contexts can provide opportunities to study basic behavioral or social processes, basic biobehavioral or biosocial interrelationships, or methodology and measurement relevant to b-BSSR.

Research Objectives

OppNet recognizes that basic research in the behavioral and social sciences can be conducted in a broad variety of settings, including general population and clinical samples. It can also be embedded within studies that include disease (or risk-factor) outcomes, so long as the focus of the study is on basic behavioral or social processes, basic biobehavioral or biosocial interrelationships, or methodology and measurement relevant to BSSR research. Basic experimental studies designed to understand a behavioral, biological, and/or sociological process(es) and/or mechanism(s) are welcome. Mechanistic behavioral trials and large-scale clinical trials that propose to influence a clinical outcome are ineligible for this FOA. Applications submitted cannot include any specific aims that propose to measure clinical efficacy or effectiveness of any intervention. Investigators who wish to conduct studies with clinical endpoints as the primary outcomes should consider other NIH FOAs. The ICs participating in this FOA have specific interests and priorities listed below. OppNet strongly encourages researchers to contact Scientific/Research contacts well in advance of submitting applications.

National Center for Complementary and Integrative Health ( NCCIH )

Understanding mechanisms of action through which complementary and integrative health approaches affect social connection and isolation on health, resiliency, and well-being across the lifespan. Examples of complementary and integrative health approaches relevant to this FOA include, but are not restricted to,

• Mind and body approaches such as meditation
• Acupuncture
• Spinal manipulation/mobilization
• Music and art therapy
• Natural products such as botanicals, probiotics, dietary supplements, and special diets

Understanding mechanisms through which social connectedness and social isolation influence cancer prevention and control outcomes, including:

• Health behaviors and decisions integral to effective cancer prevention and control, including energy balance (diet, exercise, sedentariness); alcohol consumption; smoking/tobacco initiation and cessation; and sun safety;
• Cancer-related health communication (e.g., among patient-provider, patient-caregiver)
• Adherence to cancer treatment regimens;
• Decisions regarding treatments in contexts of clinical equipoise;
• Cancer care delivery outcomes;
• Aging-related consequences of cancer and cancer treatment on symptoms and symptom management (e.g., cognitive impairment, cancer pain);
• Caregiver outcomes;
• Inequities in cancer prevention and control outcomes.

Studies that engage individuals and segments of the U.S. population that have been typically underrepresented, underserved, and excluded from biomedical, clinical, behavioral, and social sciences research are encouraged.

Social connection and isolation across the lifespan in people with visual impairment (i.e., living with blindness or low vision), including but not limited to:

• Basic and/or translational research that examines social connection and/or isolation in individuals with visual impairment
• Effects of social connection and/or isolation on adapting to progressive vision loss
• Impact of social connection and/or isolation on vision rehabilitation or assistive device use in individuals with visual impairment

Causal pathways and mechanisms through which social connectedness and social isolation are associated with health and well-being in aging, including but not limited to:

• How the availability, absence, or loss of social connections early in life shape health, well-being, and responses to social connection disruption or social isolation in mid- and late-life
• The temporal dynamics/stability of social connection/disconnection across the life course, including factors associated with persistent, chronic social disconnection versus recovery from acute social disconnection, short- and long-term resilience to changes in social supports and networks, and the mechanisms by which these factors impact health
• The role of social connections in palliative care on aging health and well-being
• Relationships between epigenetic and genetic variation and/or individual differences in gene expression and the impact of social connectedness and isolation on health and survival
• The identification of resources that promote resilience or risk factors that increase vulnerability to the unique challenges that social disconnectedness, disengagement, and isolation pose in midlife and older age; especially among individuals living with mild cognitive impairment, Alzheimer’s Disease and Related Dementias (AD/ADRD) and their caregivers
• The mechanisms by which increasing accessibility or frequency of social interactions (e.g., via social prescribing ) among socially isolated middle and older aged adults impacts health and well-being
• Identification of intervention targets for modifying social connectedness, isolation and/or loneliness and optimal time points for interventions to support healthy aging. NIA encourages a mechanisms-focused approach to behavior change intervention development as promoted by the NIH Science of Behavior Change ( https://commonfund.nih.gov/behaviorchange ) and the NIH Stage Model ( https://www.nia.nih.gv/research/dbsr/stage-model-behavioral-intervention-development) .

Impact of social connection and/or isolation across the lifespan, e.g.,

• Underlying behavioral, cultural, neurobiological mechanisms of social connection and isolation leading to alcohol misuse, alcohol use disorder (AUD), or cessation of consumption
• Effects of social connection and isolation on alcohol withdrawal and relapse
• Social media use settings, including use of non-English language social media, that facilitate social connection or isolation and subsequent impact on other behavioral and affective disorders associated with alcohol use disorder (AUD)

Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that the Alcohol Research Centers will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT OD 20-031 (Notice of NIH's Interest in Diversity). NIAAA is especially interested in enhancing representation from racial, ethnic and gender minorities and early-stage investigators.

Eunice Kennedy Shriver National Institute on Child Health and Human Development ( NICHD )

Typical and atypical social development in childhood and adolescence

• Impact of social isolation on social, affective, and cognitive development; health-related outcomes; risky and healthy behaviors in children, adolescents and individuals with intellectual and developmental disabilities (IDD)
• Individual, family-level risk and protective factors
• Relation between social isolation and other social experiences such as peer victimization
• Research to identify targets for behavioral intervention
• Understanding mechanisms by which social isolation negatively impacts health and psychosocial development
• Understanding social isolation across development and levels of development (i.e. levels of cognition)
• Social isolation and its relation to obesity in childhood and adolescence
• Understanding virtual social isolation via social media exclusion and cyberbullying
• Role of pets in promoting social capital and reducing social isolation
• Understanding social isolation among trauma-exposed youth
• Examining the effects of social isolation on recovery from injury or critical illness
• Impact of social isolation on recovery of function after illness or injury; determinants of the impact of social media or internet engagement on functional recovery
• Research to understand the interaction of social isolation with rehabilitation engagement especially through the use of novel technologies or methods
• Relationship among determinants of social connection and enhancement of rehabilitation outcomes to include improved functional status, performance, and health-related quality of life
• Examining the effects of social isolation on the development of co-occurring mental health conditions such as depression and anxiety in individuals with autism and other IDD conditions
• Examining levels of cognitive function and language abilities as predictors of social isolation
• Secondary analyses of population representative datasets to explore: community, family, and/or individual-level risk and protective factors; and the relationship between population processes, such as migration or housing change, and social isolation

Mechanistic research on the processes underlying social connection or isolation as they relate to dental, oral, or craniofacial health. Specific topics may include:

• Characterizing process by which social connection or isolation influences dental care utilization
• Understanding mechanisms by which dental, oral, or craniofacial conditions impact social processes (e.g., communication, identity, relationships, etc.)
• Illuminating processes that may inform strategies for reaching and providing dental care to individuals who are otherwise socially isolated

Mechanistic research on the impact of social connection or isolation on the substance use trajectory, including but not limited to:

• Examine protective mechanisms from social connections against drug use initiation and escalation in youth
• Characterize the effects of social media on social connection, disruption, or isolation to exacerbate SUD, or to facilitate treatment and recovery, or mitigate risk for substance use initiation
• Delineate the neurobiological, psychological, and emotional contributions of social connection trajectories to SUDs
• Identify genetic associations among social isolation and SUD
• Determine predictive biomarkers associated with social isolation and SUD
• Identify neurocognitive mechanisms by which socioenvironmental factors moderate the impact of social isolation on the substance use trajectory
• Examine social connectedness as a potential mediator or moderator of the effect of marketing on tobacco use

National Institute on Mental Health ( NIMH ) Mechanistic studies of the biopsychosocial causes and effects of social connection and isolation across the lifespan, including but not limited to:

• Neurobiological mechanisms associated with disruption of social connectedness, isolation, or perceived loneliness
• Effects of social connection and/or isolation on affective, social, and cognitive outcomes across levels of analysis
• Biopsychosocial mechanisms which increase social connectedness
• Computational neuroscience approaches to characterize social group dynamics and/or individual experience of social interactions and their impacts on emotional or cognitive systems and abilities
• Research that utilizes remote biosensors and/or ecological momentary assessments to investigate positive and negative changes in social connectedness in natural environments
• Suicide prevention interventions (e.g., in the context of the Interpersonal Theory of Suicide)
• Treatment and services for Serious Mental Illness
• HIV/AIDS treatment engagement, adherence, and/or continuation
• Mechanism-based research to identify potential intervention targets for modifying social connectedness, isolation, and/or loneliness via social media to prevent the development of clinically significant mental health symptoms

The mission of the NIMHD is to lead scientific research to improve minority health and reduce health disparities. NIMHD supports the study of many aspects of minority health and health disparities from biological and population sciences to clinical, behavioral, and translational research, as well as research on health care services, health systems and workforce development. NIMHD focuses on the full continuum of causes of health disparities and the interrelation of these causes. Projects must include a focus on one or more of the following NIH-designated populations that experience health disparities in the United States: African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, less privileged socioeconomic groups, underserved rural populations, and sexual and gender minorities (SGMs). Comparison groups/populations may also be included as appropriate for the research questions posed. NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html , for more information).

NIMHD will not support animal studies under this FOA.

For the purposes of this funding opportunity announcement, we seek to understand the interrelation between social connectedness and social isolation and minority health and health disparities.

• Impact of social connectedness and social isolation on populations that experience health disparities
• Positive and negative impacts of social connectedness and social isolation on health
• Unique challenges for health disparity populations
• Identify intervention targets for health disparity population
• Impact of interpersonal and systemic discrimination and microaggressions on social connectedness and social isolation and its impact on health outcomes
• Impact of neighborhood/place, poverty, stigma, on social connectedness and social isolation
• Impact of diverse cultures on social connectedness and social isolation

NINDS supports neurobiological mechanisms underlying the influence of social connection and isolation on the development, progression, and recovery of neurological disorders. Some examples include, but are not limited to:

• Mechanisms underlying the effect of social connection and isolation on brain and spinal cord injury, repair and recovery following Stroke, Traumatic Brain Injury, and other brain pathologies
• Human mechanistic studies of the effect of social support interventions on Alzheimer’s Disease Related Dementias
• Mechanisms underlying the effect of social connection as a coping strategy in neuromuscular disorders such as Amyotrophic Lateral Sclerosis and Spinal Muscular Atrophy
• Neurobiological studies on the identification of potential targets or strategies for successful therapeutic interventions that modify the effect of social isolation and/or connectiveness on neurological disorders

The National Institute of Nursing Research (NINR) supports research that builds the scientific foundation for nursing practice and policy across clinical and community settings, and advances the prevention, detection, and management of disease and disability. Drawing on nursing’s holistic perspective, NINR supports observational, intervention, and translational research that integrates factors at multiple levels to identify their role in health, health improvement and health inequities in varied settings including hospitals and clinics, but also people’s homes, schools, workplaces, long-term care facilities, and communities. For this PAR, NINR is especially interested in in research related to social connectedness/isolation that addresses:

Social connectedness barriers and facilitators at multiple levels: interpersonal, institutional, community, and policy

Health disparities and health disparity populations

Resilience, community support, and other potential factors that may reduce or buffer the impact of social isolation on health outcomes

Epigenetic and gene expression correlates of social isolation that may inform interventions

The potential for COVID-19 mitigation practices (e.g., social distancing, decreased family and community contact) to further exacerbate the risk for experiencing social isolation and associated poor health outcomes

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Required:Basic Experimental Studies with Humans: Only accepting applications that propose clinical trial(s) that also meet the definition of basic research.

Need help determining whether you are doing a clinical trial?

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. eligible applicants.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications ).

Section IV. Application and Submission Information

1. requesting an application package.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

Page limitations.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

Sf424(r&r) other project information, sf424(r&r) senior/key person profile.

R&R or Modular Budget

R&R Subaward Budget

Phs 398 cover page supplement, phs 398 research plan.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Section 1 - Basic Information

1.4 Clinical Trial Questionnaire

Applications to this FOA must propose a study that falls within the NIH definition of a clinical trial and also meets the definition of basic research. Consequently, applicants must answer "yes" to the four questions on 1.4 Clinical Trial Questionnaire and complete the subsequent form fields accordingly.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

Foreign institutions.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. criteria.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research .

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section .

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan ; (2) Sharing Model Organisms ; and (3) Genomic Data Sharing Plan (GDS) .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR),n accordance with NIH peer review policy and procedures , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement .

Section VI. Award Administration Information

1. award notices.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement .

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions . Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities , including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html .

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov . For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53 .
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html .
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html ; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html ; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf . For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm .
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html .

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement . NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email: [email protected] (preferred method of contact) Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email: [email protected]

The Office of Behavioral and Social Sciences Research ( OBSSR ) facilitates OppNet on behalf of NIH but cannot accept assignment of applications or manage awards that are funded. Please contact one of the IC-based contacts below for inquiries regarding the suitability of the proposed project for this FOA and the IC's research portfolio.

William Elwood, PhD Chief, Behavioral and Social Sciences Research Branch National Institute of Dental and Craniofacial Research (NIDCR) Telephone: 301-402-0116 Email: [email protected]

Cheri Wiggs National Eye Institute (NEI) Phone: (301) 402-0276 E-mail: [email protected]

Aleksandra Vicentic, Ph.D. National Institute of Mental Health (NIMH) Telephone: 301-443-1576 Email: [email protected]

Arielle Gillman, Ph.D., M.P.H. National Institute on Minority Health and Health Disparities ( NIMHD ) Telephone: 301-435-0060 Email: [email protected]

Ivana Grakalic, Ph.D. National Institute On Alcohol Abuse And Alcoholism (NIAAA) Phone: 301-443-7600 Email: [email protected]

Benjamin Xu, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phone: 301-443-6545 Email: [email protected]

Mary A Kautz National Institute On Drug Abuse (NIDA) Phone: 301-443-3206 E-mail: [email protected]

Karen Huss, PhD, RN, ANP-BC, FAAN, FAAAAI, FAHA National Institute of Nursing Research (NINR) Telephone: 301-594-5970 Email: [email protected]

David A. Jett Ph.D.

National Institute of Neurological Disorders and Stroke (NINDS) Telephone: 301-496-6035 Email: [email protected]

Liz Necka, Ph. D. National Institute on Aging (NIA) Phone: 301-480-6947 Email: [email protected]

David I. Leitman, Ph.D. National Institute of Mental Health (NIMH) Telephone:301-827-6131 Email: [email protected]

Center for Scientific review (CSR)

Email: [email protected]

Karen Robinsonsmith National Eye Institute (NEI) Phone: (301) 451-2020 E-mail: [email protected]

Priscilla Grant National Institute On Minority Health And Health Disparities (NIMHD) Phone: 301-594-8412 E-mail: [email protected]

Judy Fox National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phone: 301-443-4704 Email: [email protected]

Pamela G Fleming National Institute On Drug Abuse (NIDA) Phone: 301-480-1159 E-mail: [email protected]

Gabriel Hidalgo National Institute of Dental and Craniofacial Research (NIDCR) Telephone: 301-827-4630 Email: [email protected]

Kelli Oster National Institute of Nursing Research (NINR) Telephone: 301-594-2177 Email: [email protected]

Chief Grants Management Officer National Institute of Neurological Disorders and Stroke (NINDS) Email: [email protected]

John Bladen National Institute on Aging (NIA) Phone: 301-402-7730 Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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What is depression?

Depression (also known as major depression, major depressive disorder, or clinical depression) is a common but serious mood disorder. It causes severe symptoms that affect how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working.

To be diagnosed with depression, the symptoms must be present for at least 2 weeks.

There are different types of depression, some of which develop due to specific circumstances.

• Major depression includes symptoms of depressed mood or loss of interest, most of the time for at least 2 weeks, that interfere with daily activities.
• Persistent depressive disorder (also called dysthymia or dysthymic disorder) consists of less severe symptoms of depression that last much longer, usually for at least 2 years.
• Perinatal depression is depression that occurs during pregnancy or after childbirth. Depression that begins during pregnancy is prenatal depression, and depression that begins after the baby is born is postpartum depression.
• Seasonal affective disorder is depression that comes and goes with the seasons, with symptoms typically starting in the late fall or early winter and going away during the spring and summer.
• Depression with symptoms of psychosis is a severe form of depression in which a person experiences psychosis symptoms, such as delusions (disturbing, false fixed beliefs) or hallucinations (hearing or seeing things others do not hear or see).

People with  bipolar disorder  (formerly called manic depression or manic-depressive illness) also experience depressive episodes, during which they feel sad, indifferent, or hopeless, combined with a very low activity level. But a person with bipolar disorder also experiences manic (or less severe hypomanic) episodes, or unusually elevated moods, in which they might feel very happy, irritable, or “up,” with a marked increase in activity level.

Other depressive disorders found in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5-TR)   include disruptive mood dysregulation disorder (diagnosed in children and adolescents) and premenstrual dysphoric disorder (that affects women around the time of their period).

Who gets depression?

Depression can affect people of all ages, races, ethnicities, and genders.

Women are diagnosed with depression more often than men, but men can also be depressed. Because men may be less likely to recognize, talk about, and seek help for their feelings or emotional problems, they are at greater risk of their depression symptoms being undiagnosed or undertreated.

Studies also show higher rates of depression and an increased risk for the disorder among members of the LGBTQI+ community.

What are the signs and symptoms of depression?

If you have been experiencing some of the following signs and symptoms, most of the day, nearly every day, for at least 2 weeks, you may have depression:

• Persistent sad, anxious, or “empty” mood
• Feelings of hopelessness or pessimism
• Feelings of irritability, frustration, or restlessness
• Feelings of guilt, worthlessness, or helplessness
• Loss of interest or pleasure in hobbies and activities
• Fatigue, lack of energy, or feeling slowed down
• Difficulty concentrating, remembering, or making decisions
• Difficulty sleeping, waking too early in the morning, or oversleeping
• Changes in appetite or unplanned weight changes
• Physical aches or pains, headaches, cramps, or digestive problems without a clear physical cause that do not go away with treatment
• Thoughts of death or suicide or suicide attempts

Not everyone who is depressed experiences all these symptoms. Some people experience only a few symptoms, while others experience many. Symptoms associated with depression interfere with day-to-day functioning and cause significant distress for the person experiencing them.

Depression can also involve other changes in mood or behavior that include:

• Increased anger or irritability
• Feeling restless or on edge
• Becoming withdrawn, negative, or detached
• Increased engagement in high-risk activities
• Greater impulsivity
• Increased use of alcohol or drugs
• Isolating from family and friends
• Inability to meet the responsibilities of work and family or ignoring other important roles
• Problems with sexual desire and performance

Depression can look different in men and women. Although people of all genders can feel depressed, how they express those symptoms and the behaviors they use to cope with them may differ. For example, men (as well as women) may show symptoms other than sadness, instead seeming angry or irritable. And although increased use of alcohol or drugs can be a sign of depression in anyone, men are more likely to use these substances as a coping strategy.

In some cases, mental health symptoms appear as physical problems (for example, a racing heart, tightened chest, ongoing headaches, or digestive issues). Men are often more likely to see a health care provider about these physical symptoms than their emotional ones.

Because depression tends to make people think more negatively about themselves and the world, some people may also have thoughts of suicide or self-harm.

Several persistent symptoms, in addition to low mood, are required for a diagnosis of depression, but people with only a few symptoms may benefit from treatment. The severity and frequency of symptoms and how long they last will vary depending on the person, the illness, and the stage of the illness.

If you experience signs or symptoms of depression and they persist or do not go away, talk to a health care provider. If you see signs or symptoms of depression in someone you know, encourage them to seek help from a mental health professional.

If you or someone you know is struggling or having thoughts of suicide, call or text the 988 Suicide and Crisis Lifeline   at 988 or chat at 988lifeline.org   . In life-threatening situations, call 911 .

What are the risk factors for depression?

Depression is one of the most common mental disorders in the United States . Research suggests that genetic, biological, environmental, and psychological factors play a role in depression.

Risk factors for depression can include:

• Personal or family history of depression
• Major negative life changes, trauma, or stress

Depression can happen at any age, but it often begins in adulthood. Depression is now recognized as occurring in children and adolescents, although children may express more irritability or anxiety than sadness. Many chronic mood and anxiety disorders in adults begin as high levels of anxiety in childhood.

Depression, especially in midlife or older age, can co-occur with other serious medical illnesses, such as diabetes, cancer, heart disease, chronic pain, and Parkinson’s disease. These conditions are often worse when depression is present, and research suggests that people with depression and other medical illnesses tend to have more severe symptoms of both illnesses. The Centers for Disease Control and Prevention (CDC)  has also recognized that having certain mental disorders, including depression and schizophrenia, can make people more likely to get severely ill from COVID-19.

Sometimes a physical health problem, such as thyroid disease, or medications taken for an illness cause side effects that contribute to depression. A health care provider experienced in treating these complicated illnesses can help determine the best treatment strategy. 

How is depression treated?

Depression, even the most severe cases, can be treated. The earlier treatment begins, the more effective it is. Depression is usually treated with psychotherapy , medication , or a combination of the two.

Some people experience treatment-resistant depression, which occurs when a person does not get better after trying at least two antidepressant medications. If treatments like psychotherapy and medication do not reduce depressive symptoms or the need for rapid relief from symptoms is urgent, brain stimulation therapy  may be an option to explore.

Quick tip : No two people are affected the same way by depression, and there is no "one-size-fits-all" treatment. Finding the treatment that works best for you may take trial and error.

Psychotherapies

Several types of psychotherapy (also called talk therapy or counseling) can help people with depression by teaching them new ways of thinking and behaving and helping them change habits that contribute to depression. Evidence-based approaches to treating depression include cognitive-behavioral therapy (CBT) and interpersonal therapy (IPT). Learn more about psychotherapy .

The growth of telehealth for mental health services , which offers an alternative to in-person therapy, has made it easier and more convenient for people to access care in some cases. For people who may have been hesitant to look for mental health care in the past, virtual mental health care might be an easier option.

Medications

Antidepressants are medications commonly used to treat depression. They work by changing how the brain produces or uses certain chemicals involved in mood or stress. You may need to try several different antidepressants before finding the one that improves your symptoms and has manageable side effects. A medication that has helped you or a close family member in the past will often be considered first.

Antidepressants take time—usually 4–8 weeks—to work, and problems with sleep, appetite, and concentration often improve before mood lifts. It is important to give a medication a chance to work before deciding whether it’s right for you. Learn more about mental health medications . 

New medications, such as intranasal esketamine , can have rapidly acting antidepressant effects, especially for people with treatment-resistant depression. Esketamine is a medication approved by the U.S. Food and Drug Administration (FDA)  for treatment-resistant depression. Delivered as a nasal spray in a doctor’s office, clinic, or hospital, it acts rapidly, typically within a couple of hours, to relieve depression symptoms. People who use esketamine will usually continue taking an oral antidepressant to maintain the improvement in their symptoms.

Another option for treatment-resistant depression is to take an antidepressant alongside a different type of medication that may make it more effective, such as an antipsychotic or anticonvulsant medication. Further research is needed to identify the role of these newer medications in routine practice.

If you begin taking an antidepressant, do not stop taking it without talking to a health care provider . Sometimes people taking antidepressants feel better and stop taking the medications on their own, and their depression symptoms return. When you and a health care provider have decided it is time to stop a medication, usually after a course of 9–12 months, the provider will help you slowly and safely decrease your dose. Abruptly stopping a medication can cause withdrawal symptoms.

Note : In some cases, children, teenagers, and young adults under 25 years may experience an increase in suicidal thoughts or behavior when taking antidepressants, especially in the first few weeks after starting or when the dose is changed. The FDA advises that patients of all ages taking antidepressants be watched closely, especially during the first few weeks of treatment.

If you are considering taking an antidepressant and are pregnant, planning to become pregnant, or breastfeeding, talk to a health care provider about any health risks to you or your unborn or nursing child and how to weigh those risks against the benefits of available treatment options.

To find the latest information about antidepressants, talk to a health care provider and visit the FDA website  .

Brain stimulation therapies

If psychotherapy and medication do not reduce symptoms of depression, brain stimulation therapy may be an option to explore. There are now several types of brain stimulation therapy, some of which have been authorized by the FDA to treat depression. Other brain stimulation therapies are experimental and still being investigated for mental disorders like depression.

Although brain stimulation therapies are less frequently used than psychotherapy and medication, they can play an important role in treating mental disorders in people who do not respond to other treatments. These therapies are used for most mental disorders only after psychotherapy and medication have been tried and usually continue to be used alongside these treatments.

Brain stimulation therapies act by activating or inhibiting the brain with electricity. The electricity is given directly through electrodes implanted in the brain or indirectly through electrodes placed on the scalp. The electricity can also be induced by applying magnetic fields to the head.

The brain stimulation therapies with the largest bodies of evidence include:

• Electroconvulsive therapy (ECT)
• Repetitive transcranial magnetic stimulation (rTMS)
• Vagus nerve stimulation (VNS)
• Magnetic seizure therapy (MST)
• Deep brain stimulation (DBS)

ECT and rTMS are the most widely used brain stimulation therapies, with ECT having the longest history of use. The other therapies are newer and, in some cases, still considered experimental. Other brain stimulation therapies may also hold promise for treating specific mental disorders.

ECT, rTMS, and VNS have authorization from the FDA to treat severe, treatment-resistant depression. They can be effective for people who have not been able to feel better with other treatments; people for whom medications cannot be used safely; and in severe cases where a rapid response is needed, such as when a person is catatonic, suicidal, or malnourished.

Additional types of brain stimulation therapy are being investigated for treating depression and other mental disorders. Talk to a health care provider and make sure you understand the potential benefits and risks before undergoing brain stimulation therapy. Learn more about these brain stimulation therapies .

Natural products

The FDA has not approved any natural products for treating depression. Although research is ongoing and findings are inconsistent, some people use natural products, including vitamin D and the herbal dietary supplement St. John’s wort, for depression. However, these products can come with risks. For instance, dietary supplements and natural products can limit the effectiveness of some medications or interact in dangerous or even life-threatening ways with them.

Do not use vitamin D, St. John’s wort, or other dietary supplements or natural products without talking to a health care provider. Rigorous studies must be conducted to test whether these and other natural products are safe and effective.

Daily morning light therapy is a common treatment choice for people with seasonal affective disorder (SAD). Light therapy devices are much brighter than ordinary indoor lighting and considered safe, except for people with certain eye diseases or taking medications that increase sensitivity to sunlight. As with all interventions for depression, evaluation, treatment, and follow-up by a health care provider are strongly recommended. Research into the potential role of light therapy in treating non-seasonal depression is ongoing.

How can I find help for depression?

A primary care provider is a good place to start if you’re looking for help. They can refer you to a qualified mental health professional, such as a psychologist, psychiatrist, or clinical social worker, who can help you figure out next steps. Find tips for talking with a health care provider about your mental health.

You can learn more about getting help on the NIMH website. You can also learn about finding support  and locating mental health services  in your area on the Substance Abuse and Mental Health Services Administration (SAMHSA) website. 

Once you enter treatment, you should gradually start to feel better. Here are some other things you can do outside of treatment that may help you or a loved one feel better:

• Try to get physical activity. Just 30 minutes a day of walking can boost your mood.
• Try to maintain a regular bedtime and wake-up time.
• Eat regular, healthy meals.
• Break up large tasks into small ones; do what you can as you can. Decide what must get done and what can wait.
• Try to connect with people. Talk with people you trust about how you are feeling.
• Delay making important decisions, such as getting married or divorced, or changing jobs until you feel better. Discuss decisions with people who know you well.
• Avoid using alcohol, nicotine, or drugs, including medications not prescribed for you.

How can I find a clinical trial for depression?

Clinical trials are research studies that look at new ways to prevent, detect, or treat diseases and conditions, including depression. The goal of a clinical trial is to determine if a new test or treatment works and is safe. Although people may benefit from being part of a clinical trial, they should know that the primary purpose is to gain new scientific knowledge so that others can be better helped in the future.

Researchers at NIMH and around the country conduct many studies with people with and without depression. We have new and better treatment options today because of what clinical trials have uncovered. Talk to a health care provider about clinical trials, their benefits and risks, and whether one is right for you.

To learn more or find a study, visit:

• Clinical Trials – Information for Participants : Information about clinical trials, why people might take part in a clinical trial, and what people might experience during a clinical trial
• Clinicaltrials.gov: Current Studies on Depression   : List of clinical trials funded by the National Institutes of Health (NIH) being conducted across the country
• Join a Study: Depression—Adults : List of studies currently recruiting adults with depression being conducted on the NIH campus in Bethesda, MD
• Join a Study: Depression—Children : List of studies currently recruiting children with depression being conducted on the NIH campus in Bethesda, MD
• Join a Study: Perimenopause-Related Mood Disorders : List of studies on perimenopause-related mood disorders being conducted on the NIH campus in Bethesda, MD
• Join a Study: Postpartum Depression : List of studies on postpartum depression being conducted on the NIH campus in Bethesda, MD

Where can I learn more about depression?

Free brochures and shareable resources.

• Chronic Illness and Mental Health: Recognizing and Treating Depression : This fact sheet provides information about the link between depression and chronic disease. It describes what a chronic disease is, symptoms of depression, and treatment options, and presents resources to find help for yourself or someone else.
• Depression : This brochure provides information about depression, including different types of depression, signs and symptoms, how it is diagnosed, treatment options, and how to find help for yourself or a loved one.
• Depression in Women: 4 Things to Know : This fact sheet provides information about depression in women, including signs and symptoms, types of depression unique to women, and how to get help.
• Perinatal Depression : This brochure provides information about perinatal depression, including how it differs from “baby blues,” causes, signs and symptoms, treatment options, and how to find help for yourself or a loved one.
• Seasonal Affective Disorder : This fact sheet provides information about seasonal affective disorder, including signs and symptoms, how it is diagnosed, causes, and treatment options.
• Seasonal Affective Disorder (SAD): More Than the Winter Blues : This infographic provides information about how to recognize the symptoms of SAD and what to do to get help.
• Teen Depression: More Than Just Moodiness : This fact sheet is for teens and young adults and provides information about how to recognize the symptoms of depression and what to do to get help.
• Digital Shareables on Depression : These digital resources, including graphics and messages, can be used to spread the word about depression and help promote depression awareness and education in your community.

Federal resources

• Depression   (MedlinePlus - also en español  )
• Moms’ Mental Health Matters: Depression and Anxiety Around Pregnancy   ( Eunice Kennedy Shriver National Institute of Child Health and Human Development)

Research and statistics

• Journal Articles   : This webpage provides articles and abstracts on depression from MEDLINE/PubMed (National Library of Medicine).
• Statistics: Major Depression : This webpage provides the statistics currently available on the prevalence and treatment of depression among people in the United States.
• Depression Mental Health Minute : Take a mental health minute to watch this video on depression.
• NIMH Experts Discuss the Menopause Transition and Depression : Learn about the signs and symptoms, treatments, and latest research on depression during menopause.
• NIMH Expert Discusses Seasonal Affective Disorder : Learn about the signs and symptoms, treatments, and latest research on seasonal affective disorder.
• Discover NIMH: Personalized and Targeted Brain Stimulation Therapies : Watch this video describing repetitive transcranial magnetic stimulation and electroconvulsive therapy for treatment-resistant depression. Brain stimulation therapies can be effective treatments for people with depression and other mental disorders. NIMH supports studies exploring how to make brain stimulation therapies more personalized while reducing side effects.
• Discover NIMH: Drug Discovery and Development : One of the most exciting breakthroughs from research funded by NIMH is the development of a fast-acting medication for treatment-resistant depression based on ketamine. This video shares the story of how ketamine infusions meaningfully changed the life of a participant in an NIMH clinical trial.
• Mental Health Matters Podcast: Depression: The Case for Ketamine : Dr. Carlos Zarate Jr. discusses esketamine—the medication he helped discover—for treatment-resistant depression. The podcast covers the history behind the development of esketamine, how it can help with depression, and what the future holds for this innovative line of clinical research.

Last Reviewed: March 2024

Unless otherwise specified, the information on our website and in our publications is in the public domain and may be reused or copied without permission. However, you may not reuse or copy images. Please cite the National Institute of Mental Health as the source. Read our copyright policy to learn more about our guidelines for reusing NIMH content.