Transition Health and Resilience Through Valued Experiences (THRiVE) Pilot for Newly Separated Veterans

June 8, 2026 updated by: Shannon Blakey, RTI International

Adapting Behavioral Activation to Improve Mental Health Outcomes and Reduce Suicide Risk During the Military Transition

The objective of this study is to develop and pilot a program designed to improve mental health outcomes and reduce suicide risk during the transition from military to civilian life. It is hypothesized that the Transition Health and Resilience through Valued Experiences (THRiVE) program, to be developed as part of this study, will meet participant recruitment, retention, and satisfaction benchmarks (primary outcomes) and show positive preliminary effects on mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning outcomes (secondary outcomes).

The specific aims of this study are to:

  1. Develop a small-group, peer-led, cross-cutting prevention program for newly separated veterans (NSVs) called THRiVE and
  2. Evaluate the feasibility, acceptability, and preliminary effects of the THRiVE program on mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning outcomes.

Up to 40 NSVs participating in this Stage 1 pilot study will complete validated self-report measures at baseline, immediately after completing the THRiVE program (post-THRiVE), and 3 months after completing the THRiVE program (follow-up). The duration of a participant's time in the study is anticipated to be 5 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Transition from military to civilian life presents both opportunities and challenges. Although existing programs provide newly separated veterans (NSVs) with valuable support for their vocational well-being during the military transition, these programs do not fully address the psychosocial aspects of reintegrating into civilian life. This is problematic because the military transition is a time during which NSVs are at higher risk for developing mental health disorders and suicidal ideation. Although evidence-based treatments for common mental health concerns exist, cross-cutting prevention programs for NSVs are lacking. Behavioral Activation (BA), an evidence-based treatment that holds potential for optimizing psychosocial well-being during the military transition, could be adapted into a skills-based mental health promotion and suicide prevention program to fill this gap. This Phase 1 study involves a one-arm clinical trial to pilot test the program, called Transition Health and Resilience through Valued Experiences (THRiVE), in a sample of up to 40 NSVs. Primary outcomes include measures of feasibility (based on administrative data) and acceptability (based on administrative data and a validated self-report instrument). Mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning will be assessed (using validated self-report instruments) at baseline, immediately post-THRiVE, and at follow-up 3 months after completing the THRiVE program. The duration of a participant's time in the study is anticipated to be 5 months. Findings from this pilot study will inform the design an anticipated larger, fully powered Stage 2 trial.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shannon M Blakey, PhD
  • Phone Number: 919-485-5427
  • Email: sblakey@rti.org

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Recruiting
        • RTI International
        • Contact:
        • Principal Investigator:
          • Shannon M Blakey, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be either (a) a United States military veteran who separated no more than 12 months prior to study enrollment or (b) a United States transitioning service member on terminal leave
  • Be at least 18 years old
  • Have access to the internet; a desktop computer, laptop, tablet, or other "smart" device with video camera, speakers, and microphone; and a private place from which to attend THRiVE sessions
  • Reside and complete all study activities within the United States

Exclusion Criteria:

  • Endorse lifetime manic, hypomanic, or psychotic episodes
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current severe alcohol use disorder or substance use disorder (except for tobacco use disorder, which will not be exclusionary)
  • Screen positive for moderate or high acute risk for suicide
  • Screen positive for more than minimal risk for other-directed violence
  • Are receiving or plan to receive BA therapy for any mental health condition between enrollment and the 3-month follow-up assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: THRiVE
Behavioral: Transition Health and Resilience through Valued Experiences (THRiVE) Program
Six (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant recruitment rate
Time Frame: 14 months
The percentage of NSVs who are determined to be eligible based on their eligibility assessment and choose to enroll. It is anticipated that recruitment will begin May 2025 and enrollment of the final participant will be July 2026 (a recruitment/enrollment window of 14 months).
14 months
Participant retention rate
Time Frame: Through completion of the THRiVE group, an average of 2 months
The percentage of participants who attend at least 4 of the 6 planned total THRiVE sessions
Through completion of the THRiVE group, an average of 2 months
Client Satisfaction Questionnaire-8
Time Frame: At completion of the THRiVE group, an average of 2 months
Participant self-reported satisfaction with the THRiVE program at post-THRiVE. Possible scale scores range 8 to 32, with higher scores indicating greater program satisfaction.
At completion of the THRiVE group, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder-7
Time Frame: Through study completion, an average of 5 months
Changes in past-2-week anxiety symptoms from baseline to follow-up. Possible scale scores range 0 to 21, with higher scores indicating greater anxiety symptom severity.
Through study completion, an average of 5 months
PTSD Checklist for DSM-5
Time Frame: Through study completion, an average of 5 months
Changes in past-month posttraumatic stress symptoms from baseline to follow-up. Possible scale scores range 0 to 80, with higher scores indicating greater posttraumatic stress symptom severity.
Through study completion, an average of 5 months
Alcohol Use Disorders Identification Test
Time Frame: Through study completion, an average of 5 months
Changes in hazardous or harmful alcohol use from baseline to follow-up. Possible scale scores range 0 to 40, with higher scores indicating more hazardous or harmful alcohol use.
Through study completion, an average of 5 months
Drug Abuse Screening Test
Time Frame: Through study completion, an average of 5 months
Changes in drug misuse consequences from baseline to follow-up. Possible scale scores range 0 to 10, with higher scores indicating greater drug misuse consequences.
Through study completion, an average of 5 months
Patient Health Questionnaire-9
Time Frame: Through study completion, an average of 5 months
Changes in past-2-week depression symptoms from baseline to follow-up. Possible scale scores range 0 to 27, with higher scores indicating greater depression symptom severity.
Through study completion, an average of 5 months
Interpersonal Needs Questionnaire
Time Frame: Through study completion, an average of 5 months
Changes in thwarted belongingness and perceived burdensomeness from baseline to follow-up. Possible thwarted belongingness subscale scores range 9 to 63, with higher scores indicating greater thwarted belongingness. Possible perceived burdensomeness subscale scores range 6 to 42, with higher scores indicating greater perceived burdensomeness.
Through study completion, an average of 5 months
Positive and Negative Suicide Ideation Inventory
Time Frame: Through study completion, an average of 5 months
Changes in past-2-week protective and negative risk dimensions of suicidal ideation from baseline to follow-up. Possible protective dimension subscale scores range 6 to 30, with higher scores indicating greater protective factors. Possible negative risk dimension subscale scores range 8 to 40, with higher scores indicating greater negative risk factors.
Through study completion, an average of 5 months
Military to Civilian Questionnaire
Time Frame: Through study completion, an average of 5 months
Changes in psychosocial functioning from baseline to follow-up. Possible scale scores range 0 to 4, with higher scores indicating greater difficulties with psychosocial functioning.
Through study completion, an average of 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI International

Collaborators

U.S. Army Medical Research Acquisition Activity

Investigators

  • Principal Investigator: Shannon M Blakey, PhD, RTI International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 16, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0219706
  • HT94252410947 (Other Grant/Funding Number: Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense)
  • CDMRP-TP230060 (Other Identifier: Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense)
  • 24-08-666-907 (Other Identifier: Biomedical Research Alliance of New York)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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