Reintegration Into Civilian LifePhase 2NCT07725536
Health Coaching and Veteran Reintegration
A Phase 2 study testing Health Coaching and Enhanced treatment as usual in people with Reintegration Into Civilian Life, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study will investigate the benefits and drawbacks to two different approaches to supporting Veterans while reintegrating into civilian life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reintegration Into Civilian Life
- What is being tested?
- Health Coaching and Enhanced treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 31 Dec 2030
- Phase
- Phase 2
- 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
- All previously active-duty U.S. military service members and National Guard/Reservists separating from service to civilian life status within the prior three months will be potentially eligible
Who cannot join
- Veterans who are:
- institutionalized (e.g., prison, nursing home; self-report)
- unable to read or understand English (self-report)
- cognitively impaired (≥10 on Short Blessed Test)
- experiencing psychosis (endorsing thought interference or hallucinations of the Psychosis Screening Questionnaire)
- experiencing severe substance use (≥27 on Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST], indicating need for more intensive treatment)
- determined to be at acute risk for suicide (endorsement of suicidal ideation on the 9th item of the Patient Health Questionnaire-9 [PHQ-9] and categorized as "higher risk" on the P4 Screener)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Sarah S Ono, PhD MA, 503-220-8262 ext. 51743, Sarah.Ono@va.gov
Lauren M. Denneson, PhD
About this study
Official title: Health Coaching to Improve Functioning and Reduce Suicide Risk Among Reintegrating Veterans
This study will investigate the benefits and drawbacks to two different approaches to supporting Veterans while reintegrating into civilian life.
- Conditions
- Reintegration Into Civilian Life
- Being tested
- Health Coaching, Enhanced treatment as usual
- Keywords
- Wellbeing, Suicide
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
Also called Wellness Coaching
Up to 10 sessions of health coaching
Enhanced treatment as usualOther
Usual reintegration services plus receipt of the VA Welcome Kit
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Up to 10 sessions of health coaching Receives: Behavioral: Health Coaching |
| Enhanced treatment as usual | Active comparator | Usual reintegration services plus receipt of the VA Welcome Kit Receives: Other: Enhanced treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being inventory
Functioning in adult life roles
Measured: Month 4
Secondary outcomes (3)
Purpose in life scale
Purpose in life
Measured: Month 4
Self-concept clarity scale
Self-concept clarity
Measured: Month 4
Life engagement test
Life purpose and engagement
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Jul 2027 (estimated)
- Primary completion2 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reintegration Into Civilian LifeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Finger Lakes Healthcare System, Canandaigua VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Lauren M. Denneson, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725536
- Sponsor's protocol ID
- RRD4-007-25W
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be stored in the VA CIVIC Repository
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coaching to Improve Functioning and Reduce Suicide Risk Among Reintegrating Veterans
- ClinicalTrials.gov ID
- NCT07725536
- Acronym / sponsor ID
- RRD4-007-25W
- Conditions
- Reintegration Into Civilian Life
- Keywords
- Wellbeing, Suicide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Finger Lakes Healthcare System, Canandaigua VA Medical Center
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 2 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jul 2026 (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.
This study will investigate the benefits and drawbacks to two different approaches to supporting Veterans while reintegrating into civilian life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health CoachingUp to 10 sessions of health coaching |
| Enhanced treatment as usual | Active comparator | Other: Enhanced treatment as usualUsual reintegration services plus receipt of the VA Welcome Kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All previously active-duty U.S. military service members and National Guard/Reservists separating from service to civilian life status within the prior three months will be potentially eligible
Key exclusion criteria (7 listed)
- institutionalized (e.g., prison, nursing home; self-report)
- unable to read or understand English (self-report)
- cognitively impaired (≥10 on Short Blessed Test)
- experiencing psychosis (endorsing thought interference or hallucinations of the Psychosis Screening Questionnaire)
- experiencing severe substance use (≥27 on Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST], indicating need for more intensive treatment)
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 |
|---|---|---|
| Health CoachingAlso: Wellness CoachingUp to 10 sessions of health coaching | Behavioural | Health Coaching |
| Enhanced treatment as usualUsual reintegration services plus receipt of the VA Welcome Kit | Other | Enhanced treatment as usual |
Primary outcome
Well-being inventory
Time frame: Month 4
Functioning in adult life roles
3 secondary outcomes
Purpose in life scale
Time frame: Month 4
Self-concept clarity scale
Time frame: Month 4
Life engagement test
Time frame: Month 4
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 24 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be stored in the VA CIVIC Repository
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.
Lauren M. Denneson, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Health Coaching and Enhanced treatment as usual in people with Reintegration Into Civilian Life, run by VA Office of Research and Development 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 1 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sarah S Ono, PhD MA ((503) 220-8262 ext. 51743, Sarah.Ono@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being inventory (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.