Psychosocial FunctioningNCT07387692
Peer Support for Whole Health for Veterans
A study testing Peer Support for Whole Health and Self-Directed Whole Health in people with Psychosocial Functioning and Mental Health, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This project is evaluating a new intervention, Peer Support for Whole Health. Peer Support for Whole Health is delivered by peer support specialists, Veterans who are in recovery from mental health or substance use concerns who are employed to help other Veterans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Functioning, Mental Health
- What is being tested?
- Peer Support for Whole Health and Self-Directed Whole Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jan 2027to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans
- enrolled in primary care at one of the study sites
- have some challenges with day-to-day life (e.g., relationships, work, school, getting things done) based on a standard questionnaire
- have a recent primary care medical record note documenting potential behavioral health concerns or symptoms
- fully understand the research study
Who cannot join
- not be enrolled in current peer support services, mental health services, or other similar services
- at risk for suicide or other high-risk concerns
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Derrecka Boykin, PhD, Derrecka.Boykin@va.gov
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
Emily M Johnson, PhD, 315-425-4400 ext. 53487, emily.johnson1@va.gov
Emily M. Johnson, PhD
About this study
Official title: Randomized Controlled Trial of Peer Support for Whole Health
This project is evaluating a new intervention, Peer Support for Whole Health. Peer Support for Whole Health is delivered by peer support specialists, Veterans who are in recovery from mental health or substance use concerns who are employed to help other Veterans. Peer Support for Whole Health uses the Whole Health model to talk about values and self-care in all areas of life. Peer Support for Whole Health is designed to help Veterans who have difficulty with their relationships, work, or day-to-day life and may have behavioral health concerns. Peer Support for Whole Health is designed for Veterans in primary care who are not engaged in mental health or substance use treatment. The goal of this study is to find out whether Peer Support for Whole Health helps Veterans with relationships, work, or day-to-day life. This project will also study whether Peer Support for Whole Health improves well-being and mental health. Finally, this study will seek to understand how Peer Support for Whole Health works and which Veterans it helps the most.
- Conditions
- Psychosocial Functioning, Mental Health
- Being tested
- Peer Support for Whole Health, Self-Directed Whole Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Support for Whole HealthBehavioural
Veteran participants have one-on-one appointments with VA peer support staff to talk about VA Whole Health including goals and progress.
Self-Directed Whole HealthBehavioural
Veteran participants have an appointment with research staff and receive information about VA Whole Health tools and resources including handouts, websites, and apps.
| Study group | Role | What they receive |
|---|---|---|
| Peer Support for Whole Health | Experimental | In this arm, Veteran participants will receive Peer Support for Whole Health from VA peer support staff. Receives: Behavioral: Peer Support for Whole Health |
| Self-Directed Whole Health | Active comparator | In this arm, Veteran participants will receive information about Whole Health tools and resources from research staff. Receives: Behavioral: Self-Directed Whole Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Psychosocial Functioning
The Inventory of Psychosocial Functioning measures all key areas of psychosocial functioning including social functioning (e.g., family, parenting, romantic relationships, friendships), vocational functioning (e.g., work and school), and self-care (e.g., chores, diet, medical care).
Measured: 9 months
Secondary outcomes (2)
Well-Being Signs
The Well-Being Signs assess satisfaction, involvement, and functioning in important aspects of life.
Measured: 9 months
Depression Anxiety and Stress Scales (DASS-21)
The Depression Anxiety and Stress Scales-21 assess psychological distress including anxiety, depression, and stress-related symptoms.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start4 Jan 2027 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial FunctioningStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Emily M. Johnson, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387692
- Sponsor's protocol ID
- RRD4-011-25M
- Other IDs
- 1I01RD000397-01A
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous, de-identified data can be made available upon reasonable written request following conclusion of the trial. All identifiable information will be removed prior to sharing, and the minimum amount of data required to achieve the purposes of the request will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Peer Support for Whole Health
- ClinicalTrials.gov ID
- NCT07387692
- Acronym / sponsor ID
- RRD4-011-25M
- Conditions
- Psychosocial Functioning, Mental Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is evaluating a new intervention, Peer Support for Whole Health. Peer Support for Whole Health is delivered by peer support specialists, Veterans who are in recovery from mental health or substance use concerns who are employed to help other Veterans. Peer Support for Whole Health uses the Whole Health model to talk about values and self-care in all areas of life. Peer Support for Whole Health is designed to help Veterans who have difficulty with their relationships, work, or day-to-day life and may have behavioral health concerns. Peer Support for Whole Health is designed for Veterans in primary care who are not engaged in mental health or substance use treatment. The goal of this study is to find out whether Peer Support for Whole Health helps Veterans with relationships, work, or day-to-day life. This project will also study whether Peer Support for Whole Health improves well-being and mental health. Finally, this study will seek to understand how Peer Support for Whole Health works and which Veterans it helps the most.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Support for Whole Health | Experimental | Behavioral: Peer Support for Whole HealthIn this arm, Veteran participants will receive Peer Support for Whole Health from VA peer support staff. |
| Self-Directed Whole Health | Active comparator | Behavioral: Self-Directed Whole HealthIn this arm, Veteran participants will receive information about Whole Health tools and resources from research staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans
- enrolled in primary care at one of the study sites
- have some challenges with day-to-day life (e.g., relationships, work, school, getting things done) based on a standard questionnaire
- have a recent primary care medical record note documenting potential behavioral health concerns or symptoms
- fully understand the research study
Key exclusion criteria (2 listed)
- not be enrolled in current peer support services, mental health services, or other similar services
- at risk for suicide or other high-risk concerns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Support for Whole HealthVeteran participants have one-on-one appointments with VA peer support staff to talk about VA Whole Health including goals and progress. | Behavioural | Peer Support for Whole Health |
| Self-Directed Whole HealthVeteran participants have an appointment with research staff and receive information about VA Whole Health tools and resources including handouts, websites, and apps. | Behavioural | Self-Directed Whole Health |
Primary outcome
Inventory of Psychosocial Functioning
Time frame: 9 months
The Inventory of Psychosocial Functioning measures all key areas of psychosocial functioning including social functioning (e.g., family, parenting, romantic relationships, friendships), vocational functioning (e.g., work and school), and self-care (e.g., chores, diet, medical care).
2 secondary outcomes
Well-Being Signs
Time frame: 9 months
Depression Anxiety and Stress Scales (DASS-21)
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes. Anonymous, de-identified data can be made available upon reasonable written request following conclusion of the trial. All identifiable information will be removed prior to sharing, and the minimum amount of data required to achieve the purposes of the request will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily M. Johnson, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support for Whole Health and Self-Directed Whole Health in people with Psychosocial Functioning and Mental Health, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily M Johnson, PhD ((315) 425-4400 ext. 53487, emily.johnson1@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Psychosocial Functioning (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.