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

NCT ID: NCT06778278

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Military Transition Community Reintegration Mental Health Suicidal Ideation Alcohol Misuse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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THRiVE

Group Type EXPERIMENTAL

Transition Health and Resilience through Valued Experiences (THRiVE) Program

Intervention Type BEHAVIORAL

Six (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually

Interventions

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Transition Health and Resilience through Valued Experiences (THRiVE) Program

Six (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Be a United States military veteran
* Have separated/retired from the military no more than 12 months prior to study enrollment
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Army Medical Research Acquisition Activity

FED

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role lead

Responsible Party

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Shannon Blakey

Research Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shannon M Blakey, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

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RTI International

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shannon M Blakey, PhD

Role: CONTACT

919-485-5427

Russ Peeler, MS

Role: CONTACT

Facility Contacts

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Principal Investigator

Role: primary

919-485-5427

References

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Blakey SM, Vandermaas-Peeler JR, Counts J, Croxford J, Rae Olmsted KL, Gant P, Elbogen EB, Asman K. Bringing veteran mental health promotion and suicide prevention efforts upstream: The THRiVE study protocol. Contemp Clin Trials. 2025 Nov;158:108100. doi: 10.1016/j.cct.2025.108100. Epub 2025 Oct 4.

Reference Type DERIVED
PMID: 41052716 (View on PubMed)

Other Identifiers

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0219706

Identifier Type: -

Identifier Source: org_study_id

HT94252410947

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDMRP-TP230060

Identifier Type: OTHER

Identifier Source: secondary_id

24-08-666-907

Identifier Type: OTHER

Identifier Source: secondary_id

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