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NCT Number: NCT06778278

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RTI International

Durham, North Carolina, 27713, United States

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

919-485-5427

Shannon M Blakey, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transition Health and Resilience through Valued Experiences (THRiVE) Program

Behavioral

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

Primary outcomes

  1. 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).

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Russ Peeler, MS

CONTACT

[email protected]

Shannon M Blakey, PhD

CONTACT

[email protected]

919-485-5427

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • U.S. Army Medical Research Acquisition Activity

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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