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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

384 Participants
are divided into 2 treatment groups
Group A: Stage 1Experimental treatment 2 interventions
Group B: Stage 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
baseline to 24 weeks

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
baseline to 24 weeks

Other outcomes

1

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
2

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
3

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

Sponsors and contacts

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