NCT07507747

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
47mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

March 27, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

peer supportmHealthVeteransSMART designpsychological distress

Outcome Measures

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.

    baseline to 24 weeks

Secondary Outcomes (6)

  • Post Traumatic Stess Checklist-5

    baseline to 24 weeks

  • Insomnia Severity Index

    baseline to 25 weeks

  • Dimensions of Anger Reactions

    baseline to 24 weeks

  • Brief Inventory of Psychosocial Functioning

    baseline to 24 weeks

  • Satisfaction with Life Questionnaire

    baseline to 24 weeks

  • +1 more secondary outcomes

Other Outcomes (3)

  • University of Rhode Island Change Assessment

    baseline to 24 weeks

  • Coping Self Efficacy Scale

    baseline to 24 weeks

  • Assessing Circumstances and Offering Resources for Needs

    baseline to 24 weeks

Study Arms (2)

Stage 1

EXPERIMENTAL

Stage 1 randomization

Behavioral: Self Managed mHealthBehavioral: 1 session of peer mHealth

Stage 2

EXPERIMENTAL

Stage 2 randomization

Behavioral: Self Managed mHealthBehavioral: 4 sessions Peer mHealthBehavioral: 4 sessions of Peer Whole Health

Interventions

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

Stage 1

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

Stage 2

Patients receive 4 session with a peer focused on Whole Health

Stage 2

Patients use mHealth apps to manage psychological distress

Stage 1Stage 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

Location

Study Officials

  • Kyle Possemato, PhD

    Syracuse VA Medical Center, Syracuse, NY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle Possemato, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: SMART
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations