Military TransitionNCT06778278
Transition Health and Resilience Through Valued Experiences (THRiVE) Pilot for Newly Separated Veterans
A study testing Transition Health and Resilience through Valued Experiences (THRiVE) Program in people with Military Transition and Community Reintegration, run by RTI International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Military Transition, Community Reintegration, Mental Health
- What is being tested?
- Transition Health and Resilience through Valued Experiences (THRiVE) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russ Peeler, MS contact
United States1 site, 1 recruiting
- Recruiting
RTI International
Durham, North Carolina, 27713
Principal Investigator, 919-485-5427, thrivestudy@rti.org
Shannon M Blakey, PhD
About this study
Official title: 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:
Read more
- Develop a small-group, peer-led, cross-cutting prevention program for newly separated veterans (NSVs) called THRiVE and
- 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.
Read the 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.
- Conditions
- Military Transition, Community Reintegration, Mental Health, Suicidal Ideation, Alcohol Misuse
- Being tested
- Transition Health and Resilience through Valued Experiences (THRiVE) Program
- Keywords
- Military transition, Community reintegration, Mental health, Suicidal ideation, Transitioning Service Members, Newly separated Veterans
- Medical subject headings
- Psychological Well-Being, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition Health and Resilience through Valued Experiences (THRiVE) ProgramBehavioural
Six (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually
| Study group | Role | What they receive |
|---|---|---|
| THRiVE | Experimental | Not described Receives: Behavioral: Transition Health and Resilience through Valued Experiences (THRiVE) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 months
Participant retention rate
The percentage of participants who attend at least 4 of the 6 planned total THRiVE sessions
Measured: 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.
Measured: At completion of the THRiVE group, an average of 2 months
Secondary outcomes (8)
Generalized Anxiety Disorder-7
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.
Measured: Through study completion, an average of 5 months
PTSD Checklist for DSM-5
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.
Measured: Through study completion, an average of 5 months
Alcohol Use Disorders Identification Test
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.
Measured: Through study completion, an average of 5 months
Drug Abuse Screening Test
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.
Measured: Through study completion, an average of 5 months
Patient Health Questionnaire-9
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.
Measured: Through study completion, an average of 5 months
Interpersonal Needs Questionnaire
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.
Measured: Through study completion, an average of 5 months
Positive and Negative Suicide Ideation Inventory
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.
Measured: Through study completion, an average of 5 months
Military to Civilian Questionnaire
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.
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start30 Jul 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Military TransitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Responsible party
- Principal investigator, Shannon Blakey, RTI International
- Investigators
- Shannon M Blakey, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778278
- Sponsor's protocol ID
- 0219706
- Other IDs
- HT94252410947, CDMRP-TP230060, 24-08-666-907
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41052716
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Behavioral Activation to Improve Mental Health Outcomes and Reduce Suicide Risk During the Military Transition
- ClinicalTrials.gov ID
- NCT06778278
- Acronym / sponsor ID
- 0219706
- Conditions
- Military Transition, Community Reintegration, Mental Health, Suicidal Ideation, Alcohol Misuse
- Keywords
- Military transition, Community reintegration, Mental health, Suicidal ideation, Transitioning Service Members, Newly separated Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Develop a small-group, peer-led, cross-cutting prevention program for newly separated veterans (NSVs) called THRiVE and
- 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
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THRiVE | Experimental | Behavioral: Transition Health and Resilience through Valued Experiences (THRiVE) Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition Health and Resilience through Valued Experiences (THRiVE) ProgramSix (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually | Behavioural | THRiVE |
Primary outcome
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).
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
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.
8 secondary outcomes
Generalized Anxiety Disorder-7
Time frame: Through study completion, an average of 5 months
PTSD Checklist for DSM-5
Time frame: Through study completion, an average of 5 months
Alcohol Use Disorders Identification Test
Time frame: Through study completion, an average of 5 months
Drug Abuse Screening Test
Time frame: Through study completion, an average of 5 months
Patient Health Questionnaire-9
Time frame: Through study completion, an average of 5 months
Interpersonal Needs Questionnaire
Time frame: Through study completion, an average of 5 months
Positive and Negative Suicide Ideation Inventory
Time frame: Through study completion, an average of 5 months
Military to Civilian Questionnaire
Time frame: Through study completion, an average of 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 41052716Blakey 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Russ Peeler, MS contact
Shannon M Blakey, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition Health and Resilience through Valued Experiences (THRiVE) Program in people with Military Transition and Community Reintegration, run by RTI International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon M Blakey, PhD (919-485-5427, sblakey@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment rate (time frame: 14 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.