Peer-Supported Mobile Health for Psychological Distress

(Peer mHealth Trial)

Not yet recruiting at 4 trial locations

Overseen By Kyle Possemato, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Psychotropic medications

Disqualifiers: Cognitive impairment, Mania, Psychosis, Suicide risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Kyle Possemato, PhD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Intervention

Participants are randomized to receive either Self-Managed mHealth or one peer phone call to support mHealth. Response is measured after 4 weeks.

4 weeks

1 visit (virtual)

Stage 2 Intervention

Slow responders are randomized to additional mHealth peer phone calls or peer-delivered Whole Health. Early responders continue or step-down to Self-Managed mHealth.

8 weeks

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with reassessments at 12, 16, and 24 weeks post-enrollment.

12 weeks

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Peer-supported mHealth

How Is the Trial Designed?

Group I: Stage 2 Experimental Treatment 3 Interventions

Stage 2 randomization

Group II: Stage 1 Experimental Treatment 2 Interventions

Stage 1 randomization

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+