Psychological DistressPeer mHealthNCT07507747
Testing an Adaptive Intervention for Peer-Supported Mobile Health for Primary Care Veterans With Psychological Distress
A study testing Self Managed mHealth, 1 session of peer mHealth and 4 sessions Peer mHealth in people with Psychological Distress, run by VA Office of Research and Development at 5 sites in United States.
Trial summary
Many Veterans experience psychological distress including depression, post-traumatic stress disorder (PTSD), anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Self Managed mHealth, 1 session of peer mHealth and 4 sessions Peer mHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Sep 2026to 30 Apr 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
- Veteran enrolled in primary care at one of 3 VA facilities (Philadelphia, PA; Ann Arbor, MI; and Bedford, MA)
- clinically significant psychological distress on at least one DASS-21 subscale (Depression => 10, Anxiety => 8, Stress => 13)
Who cannot join
- symptoms that may preclude active engagement in the intervention such as gross cognitive impairment or current symptoms of mania or psychosis
- suicide risk as measured by the P4 Suicide Assessment
- plan to engage in psychotherapy during the intervention period
- started or changed the dose of a psychotropic medication in the last two months
- voice a preference to be directly referred to mental health specialty care
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Rebecca Sripada, Rebecca.Sripada@va.gov
- Not yet recruiting
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
Andrew Peckham, Andrew.Peckham@va.gov
- Not yet recruiting
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Jennifer Smith, Jennifer.Smith@va.gov
- Not yet recruiting
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
Travis Cos, travis.cos@va.gov
- Recruiting
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
Kyle Possemato, PhD, (315) 425-4400 ext. 53551, kyle.possemato@va.gov
Kyle Possemato, PhD
About this study
Many Veterans experience psychological distress including depression, post-traumatic stress disorder (PTSD), anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.
Read the detailed description
Background: Psychological distress in Veterans Affairs (VA) primary care patients is common and often not adequately treated. The VA has a suite of evidence-informed mobile health applications (mHealth apps) for psychological distress that are frequently downloaded, but most Veterans do not use them enough to experience health benefits. Support from helping professionals, such as peer specialists, can increase app use and health benefits. The study team found that peer-supported mHealth is feasible to deliver in VA primary care, increases app engagement and is associated with high satisfaction and improved Veteran health. However, not all individuals need the same amount of support when using mHealth. This study will test an adaptive intervention using a SMART design to match patient need with specific doses of peer support for mHealth.
Significance: The long-term goal is to improve the health of Veterans with psychological distress by developing a brief and efficient stepped-care intervention that can be feasibly implemented in VA primary care settings. This proposal is highly aligned with the priorities of the operational partners in the Offices of Mental Health and Patient Centered Care \& Cultural Transformation and VA BBMH. The findings will support the VA-wide expansion of the Peers in PACT program, per recent STRONG Act legislation.
Innovation \& Impact: Key innovations include the use of a SMART design to develop an adaptive intervention for a high-priority patient population and the novel application of the Supportive Accountability model in which human support is critical to enhancing adherence to mHealth interventions. The proposal will also provide much needed data on the effectiveness of peers to deliver brief, structured interventions.
Specific Aims: 1) Test the effectiveness of a) stage 1 (Peer mHealth vs. Self-Managed mHealth), b) stage 2 interventions (4 sessions of Peer mHealth vs. Peer Whole Health) among slow responders and c) the embedded stepped-care treatment sequences on psychological distress and secondary outcomes (e.g., app use, cost, mental health service use, symptoms, functioning) at 12 weeks. 2) Examine candidate tailoring variables as predictors of outcomes in a) stage 1 (i.e., motivation, coping self-efficacy) and b) stage 2 (i.e., app use and unmet social needs). Race/ethnicity and sex/gender will also be explored as moderators. 3) Assess barriers and facilitators to implementing adaptive interventions for peer mHealth in PACT by interviewing key VHA leadership, staff and Veteran stakeholders.
Methodology: Participants (N=384) with significant psychological distress who are not engaged in specialty mental health care will be randomized at Stage 1 to receive either Self-Managed mHealth or one peer phone call to support mHealth. Participant response, defined as a reliable decrease in psychological distress (5-point decrease in any DASS-21 subscale) will be measured after 4 weeks. Stage 2 randomization will assign slow responders to step-up to additional mHealth peer phone calls or an alternative peer support model (peer-delivered Whole Health). Stage 1 early responders will continue/ step-down to Self-Managed mHealth. All participants will be reassessed at 12, 16 and 24 weeks post-enrollment. Psychological distress is the primary outcome. Secondary outcomes include app use, mental health service use, cost, psychological symptoms (e.g., depression, anxiety, stress, PTSD, anger, sleep), and functioning (e.g., social functioning).
Next Steps/ Implementation: Should these results support the effectiveness of the adaptive intervention, the investigators will disseminate peer training through the Peers in PACT and Tech into Care VA networks. The investigators will also prepare a new ORD application to systemically investigate how the adaptive intervention can be implemented in VA.
- Conditions
- Psychological Distress
- Being tested
- Self Managed mHealth, 1 session of peer mHealth, 4 sessions Peer mHealth, 4 sessions of Peer Whole Health
- Keywords
- peer support, mHealth, Veterans, SMART design, psychological distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Managed mHealthBehavioural
Patients use mHealth apps to manage psychological distress
1 session of peer mHealthBehavioural
Patients receive one session with a peer while using mHealth apps to manage psychological distress
4 sessions Peer mHealthBehavioural
Patients receive 4 sessions with a peer while using mHealth apps to manage psychological distress
4 sessions of Peer Whole HealthBehavioural
Patients receive 4 session with a peer focused on Whole Health
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Experimental | Stage 1 randomization Receives: Behavioral: Self Managed mHealth; Behavioral: 1 session of peer mHealth |
| Stage 2 | Experimental | Stage 2 randomization Receives: Behavioral: Self Managed mHealth; Behavioral: 4 sessions Peer mHealth; Behavioral: 4 sessions of Peer Whole Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety and Stress Scale
Depression Anxiety and Stress Scale is a widely used measure of psychological distress consisting of 21 items measured on a 4-point scale. The total score ranges from 0-63. Higher scores indicate greater severity.
Measured: baseline to 24 weeks
Secondary outcomes (6)
Post Traumatic Stess Checklist-5
Self report measure assessing the 21 symptoms of post-traumatic stress disorder (PTSD) on a 5 point scale. Total score ranges from 0-105. Higher scores indicate greater severity.
Measured: baseline to 24 weeks
Insomnia Severity Index
Self report measure assessing insomnia with 7 questions on a 5 point scale. Total score range from 0-28. Higher scores indicate greater severity.
Measured: baseline to 25 weeks
Dimensions of Anger Reactions
Self report measure assessing anger with 5 items on a 5 point scale. Total score ranges from 5-25. Higher scores indicate greater severity.
Measured: baseline to 24 weeks
Brief Inventory of Psychosocial Functioning
Self report measure of psychosocial functioning measured with 7 items on 7 point scale. Total ranges from 0-42. Higher scores indicate more dysfunction.
Measured: baseline to 24 weeks
Satisfaction with Life Questionnaire
Self report measure assessing life satisfaction with 5 items on an eight point scale. Total score ranges from 5-35. High scores indicate greater satisfaction.
Measured: baseline to 24 weeks
Client Satisfaction Questionnaire
Self report measure assessing participant satisfaction with study interventions with 8 items measures on a 4 point scale. Total score ranges from 0-24. Higher scores indicate greater satisfaction.
Measured: baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start27 Sep 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- SMART
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kyle Possemato, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507747
- Sponsor's protocol ID
- HSR4-014-24W
- Other IDs
- 1I01RD000522-01A2
- Acronym
- Peer mHealth
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Adaptive Intervention for Peer-Supported Mobile Health for Primary Care Veterans With Psychological Distress
- ClinicalTrials.gov ID
- NCT07507747
- Acronym / sponsor ID
- Peer mHealth / HSR4-014-24W
- Conditions
- Psychological Distress
- Keywords
- peer support, mHealth, Veterans, SMART design, psychological distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 27 Sep 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 2 Apr 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.
Many Veterans experience psychological distress including depression, post-traumatic stress disorder (PTSD), anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.
Detailed description
Background: Psychological distress in Veterans Affairs (VA) primary care patients is common and often not adequately treated. The VA has a suite of evidence-informed mobile health applications (mHealth apps) for psychological distress that are frequently downloaded, but most Veterans do not use them enough to experience health benefits. Support from helping professionals, such as peer specialists, can increase app use and health benefits. The study team found that peer-supported mHealth is feasible to deliver in VA primary care, increases app engagement and is associated with high satisfaction and improved Veteran health. However, not all individuals need the same amount of support when using mHealth. This study will test an adaptive intervention using a SMART design to match patient need with specific doses of peer support for mHealth.
Significance: The long-term goal is to improve the health of Veterans with psychological distress by developing a brief and efficient stepped-care intervention that can be feasibly implemented in VA primary care settings. This proposal is highly aligned with the priorities of the operational partners in the Offices of Mental Health and Patient Centered Care \& Cultural Transformation and VA BBMH. The findings will support the VA-wide expansion of the Peers in PACT program, per recent STRONG Act legislation.
Innovation \& Impact: Key innovations include the use of a SMART design to develop an adaptive intervention for a high-priority patient population and the novel application of the Supportive Accountability model in which human support is critical to enhancing adherence to mHealth interventions. The proposal will also provide much needed data on the effectiveness of peers to deliver brief, structured interventions.
Specific Aims: 1) Test the effectiveness of a) stage 1 (Peer mHealth vs. Self-Managed mHealth), b) stage 2 interventions (4 sessions of Peer mHealth vs. Peer Whole Health) among slow responders and c) the embedded stepped-care treatment sequences on psychological distress and secondary outcomes (e.g., app use, cost, mental health service use, symptoms, functioning) at 12 weeks. 2) Examine candidate tailoring variables as predictors of outcomes in a) stage 1 (i.e., motivation, coping self-efficacy) and b) stage 2 (i.e., app use and unmet social needs). Race/ethnicity and sex/gender will also be explored as moderators. 3) Assess barriers and facilitators to implementing adaptive interventions for peer mHealth in PACT by interviewing key VHA leadership, staff and Veteran stakeholders.
Methodology: Participants (N=384) with significant psychological distress who are not engaged in specialty mental health care will be randomized at Stage 1 to receive either Self-Managed mHealth or one peer phone call to support mHealth. Participant response, defined as a reliable decrease in psychological distress (5-point decrease in any DASS-21 subscale) will be measured after 4 weeks. Stage 2 randomization will assign slow responders to step-up to additional mHealth peer phone calls or an alternative peer support model (peer-delivered Whole Health). Stage 1 early responders will continue/ step-down to Self-Managed mHealth. All participants will be reassessed at 12, 16 and 24 weeks post-enrollment. Psychological distress is the primary outcome. Secondary outcomes include app use, mental health service use, cost, psychological symptoms (e.g., depression, anxiety, stress, PTSD, anger, sleep), and functioning (e.g., social functioning).
Next Steps/ Implementation: Should these results support the effectiveness of the adaptive intervention, the investigators will disseminate peer training through the Peers in PACT and Tech into Care VA networks. The investigators will also prepare a new ORD application to systemically investigate how the adaptive intervention can be implemented in VA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SMART
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | Experimental | Behavioral: Self Managed mHealth, Behavioral: 1 session of peer mHealthStage 1 randomization |
| Stage 2 | Experimental | Behavioral: Self Managed mHealth, Behavioral: 4 sessions Peer mHealth, Behavioral: 4 sessions of Peer Whole HealthStage 2 randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veteran enrolled in primary care at one of 3 VA facilities (Philadelphia, PA; Ann Arbor, MI; and Bedford, MA)
- clinically significant psychological distress on at least one DASS-21 subscale (Depression => 10, Anxiety => 8, Stress => 13)
Key exclusion criteria (5 listed)
- symptoms that may preclude active engagement in the intervention such as gross cognitive impairment or current symptoms of mania or psychosis
- suicide risk as measured by the P4 Suicide Assessment
- plan to engage in psychotherapy during the intervention period
- started or changed the dose of a psychotropic medication in the last two months
- voice a preference to be directly referred to mental health specialty care
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 |
|---|---|---|
| Self Managed mHealthPatients use mHealth apps to manage psychological distress | Behavioural | Stage 1, Stage 2 |
| 1 session of peer mHealthPatients receive one session with a peer while using mHealth apps to manage psychological distress | Behavioural | Stage 1 |
| 4 sessions Peer mHealthPatients receive 4 sessions with a peer while using mHealth apps to manage psychological distress | Behavioural | Stage 2 |
| 4 sessions of Peer Whole HealthPatients receive 4 session with a peer focused on Whole Health | Behavioural | Stage 2 |
Primary outcome
Depression Anxiety and Stress Scale
Time frame: baseline to 24 weeks
Depression Anxiety and Stress Scale is a widely used measure of psychological distress consisting of 21 items measured on a 4-point scale. The total score ranges from 0-63. Higher scores indicate greater severity.
6 secondary outcomes
Post Traumatic Stess Checklist-5
Time frame: baseline to 24 weeks
Insomnia Severity Index
Time frame: baseline to 25 weeks
Dimensions of Anger Reactions
Time frame: baseline to 24 weeks
Brief Inventory of Psychosocial Functioning
Time frame: baseline to 24 weeks
Satisfaction with Life Questionnaire
Time frame: baseline to 24 weeks
Client Satisfaction Questionnaire
Time frame: baseline to 24 weeks
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 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Kyle Possemato, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Managed mHealth, 1 session of peer mHealth and 4 sessions Peer mHealth in people with Psychological Distress, run by VA Office of Research and Development at 5 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Kyle Possemato, PhD ((315) 425-4400 ext. 53551, kyle.possemato@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety and Stress Scale (time frame: baseline to 24 weeks). 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 2 Oct 2026.