NCT06778278

Brief Summary

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. 1.Develop a small-group, peer-led, cross-cutting prevention program for newly separated veterans (NSVs) called THRiVE and
  2. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
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

Study Progress61%
Jul 2025Oct 2026

First Submitted

Initial submission to the registry

January 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 9, 2025

Last Update Submit

January 20, 2026

Conditions

Keywords

Military transitionCommunity reintegrationMental healthSuicidal ideationTransitioning Service MembersNewly separated Veterans

Outcome Measures

Primary Outcomes (3)

  • Participant recruitment rate

    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

    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

    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 Outcomes (8)

  • Generalized Anxiety Disorder-7

    Through study completion, an average of 5 months

  • PTSD Checklist for DSM-5

    Through study completion, an average of 5 months

  • Alcohol Use Disorders Identification Test

    Through study completion, an average of 5 months

  • Drug Abuse Screening Test

    Through study completion, an average of 5 months

  • Patient Health Questionnaire-9

    Through study completion, an average of 5 months

  • +3 more secondary outcomes

Study Arms (1)

THRiVE

EXPERIMENTAL
Behavioral: Transition Health and Resilience through Valued Experiences (THRiVE) Program

Interventions

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

THRiVE

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Endorse lifetime manic, hypomanic, or psychotic episodes
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RTI International

Durham, North Carolina, 27713, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-BeingSuicidal Ideation

Interventions

Health TransitionNicotine

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSuicideSelf-Injurious BehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Population DynamicsDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Shannon M Blakey, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon M Blakey, PhD

CONTACT

Russ Peeler, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Clinical Psychologist

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 16, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations