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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • 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

    Not yet 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

    Recruiting

Other trials in United States

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.

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 groups in NCT07507747
Study groupRoleWhat they receive
Stage 1ExperimentalStage 1 randomization
Receives: Behavioral: Self Managed mHealth; Behavioral: 1 session of peer mHealth
Stage 2ExperimentalStage 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted2 Apr 2026
  2. Study start27 Sep 2026
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

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)
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

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.

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Peer mHealth Clinical Trial NCT07507747 | AzTrials