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NCT Number: NCT07507747

Testing an Adaptive Intervention for Peer-Supported Mobile Health for Primary Care Veterans With Psychological Distress

Many Veterans experience psychological distress including depression, 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Self Managed mHealth

Behavioral

Patients use mHealth apps to manage psychological distress

1 session of peer mHealth

Behavioral

Patients receive one session with a peer while using mHealth apps to manage psychological distress

4 sessions Peer mHealth

Behavioral

Patients receive 4 sessions with a peer while using mHealth apps to manage psychological distress

4 sessions of Peer Whole Health

Behavioral

Patients receive 4 session with a peer focused on Whole Health

Primary outcomes

  1. 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.

Secondary outcomes

  1. Post Traumatic Stess Checklist-5

    Time frame: baseline to 24 weeks

    Self report measure assessing the 21 symptoms of PTSD on a 5 point scale. Total score ranges from 0-105. Higher scores indicate greater severity.

  2. Insomnia Severity Index

    Time frame: baseline to 25 weeks

    Self report measure assessing insomnia with 7 questions on a 5 point scale. Total score range from 0-28. Higher scores indicate greater severity.

  3. Dimensions of Anger Reactions

    Time frame: baseline to 24 weeks

    Self report measure assessing anger with 5 items on a 5 point scale. Total score ranges from 5-25. Higher scores indicate greater severity.

  4. Brief Inventory of Psychosocial Functioning

    Time frame: baseline to 24 weeks

    Self report measure of psychosocial functioning measured with 7 items on 7 point scale. Total ranges from 0-42. Higher scores indicate more dysfunction.

  5. Satisfaction with Life Questionnaire

    Time frame: baseline to 24 weeks

    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.

  6. Client Satisfaction Questionnaire

    Time frame: baseline to 24 weeks

    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.

Other outcomes

  1. University of Rhode Island Change Assessment

    Time frame: baseline to 24 weeks

    Self report measure assessing patient motivation to address psychological distress with 12 items on a 5 point scale. Total score ranges from 12 to 60. Higher scores indicate more motivation.

  2. Coping Self Efficacy Scale

    Time frame: baseline to 24 weeks

    Self report measure to assess patient self efficacy to address psychological distress with 26 items on a 11 point scale. Total score ranges from 0-260 with higher scores indicating greater self-efficacy.

  3. Assessing Circumstances and Offering Resources for Needs

    Time frame: baseline to 24 weeks

    Measure of unmet social needs that include 11 questions. The total score ranges from 0-48 with higher scores indicating more unmet needs.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyle Possemato, PhD

CONTACT

[email protected]

(315) 425-4400 ext. 53551

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: Peer mHealth

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 2, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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