An interventional study of Self Managed mHealth and 1 session of peer mHealth in Psychological Distress, sponsored by VA Office of Research and Development. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Stage 1 randomization
Behavioral: Self Managed mHealth · Behavioral: 1 session of peer mHealth
Stage 2 randomization
Behavioral: Self Managed mHealth · Behavioral: 4 sessions Peer mHealth · Behavioral: 4 sessions of Peer Whole Health
Patients use mHealth apps to manage psychological distress
Patients receive one session with a peer while using mHealth apps to manage psychological distress
Patients receive 4 sessions with a peer while using mHealth apps to manage psychological distress
Patients receive 4 session with a peer focused on Whole Health
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.
Time frame: baseline to 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline to 24 weeks
University of Rhode Island Change Assessment
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.
Time frame: baseline to 24 weeks
Coping Self Efficacy Scale
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.
Time frame: baseline to 24 weeks
Assessing Circumstances and Offering Resources for Needs
Measure of unmet social needs that include 11 questions. The total score ranges from 0-48 with higher scores indicating more unmet needs.
Time frame: baseline to 24 weeks
Plan to share: No
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