- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05199467
Health Coaching: A Pilot Trial Among Reintegrating Veterans
May 13, 2026 updated by: VA Office of Research and Development
A Pilot Trial of Health Coaching to Improve Functioning and Reduce Suicide Risk Among Reintegrating Veterans
Health coaches help people focus on goals, identify strengths and values, and work towards building the life they wish to live.
Health coaching may be especially helpful for people navigating a life transition, such as Veterans who recently separated from military service (i.e., reintegrating Veterans).
In this pilot trial the investigators will 1) examine the feasibility of study procedures and acceptability of health coaching among reintegrating Veterans, 2) evaluate measures for suitability in a future trial that will examine efficacy of the intervention, 3) determine barriers and facilitators to implementing the intervention among reintegrating Veterans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This pilot study is designed to provide data to inform the design and procedures of a future efficacy trial of health coaching among reintegrating Veterans.
An enrollment rate 30% and an assessment completion rate 65% at 9 months will be considered feasible enrollment and assessment completion rates for a future efficacy trial.
An intervention completion rate 70% and mean score 27 on the Client Satisfaction Questionnaire-8 will indicate acceptability.
Evaluation of measures will entail quantifying the mean levels in this population, characterizing typical variation in the outcomes, descriptive analyses of within-person change across time, and adjusted estimates of treatment effect sizes with 95% confidence intervals to calibrate the sample size needs of a fully powered trial.
Qualitative interviews with participants will provide information on barriers and facilitators to implementation as well as perceived benefits and potential harms.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97207-2964
- VA Portland Health Care System, Portland, OR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- United States military Veterans recently separated from service
Exclusion Criteria:
- Currently living in an institution (e.g., nursing home, prison)
- Cognitive impairment as indicated by a score equal to or greater than 10 on the Short Blessed Test
- Currently experiencing psychosis as indicated by endorsing thought interference or hallucinations on the Psychosis Screening Questionnaire
- At acute risk for suicide as indicated by the P4 screener
- Unable to read or understand English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health Coaching
Receipt of up to 12 sessions of health coaching, plus printed materials providing information on VA benefits
|
Health coaches help people focus on goals, identify strengths and values, and work towards building the kind of life they wish to live.
Printed materials with information on VA benefits.
|
|
Active Comparator: VA Benefits Information
Receipt of printed materials providing information on VA benefits
|
Printed materials with information on VA benefits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Military to Civilian Questionnaire
Time Frame: Month 4
|
The Military to Civilian Questionnaire scores range from 0 to 4, with higher scores indicating a higher degree of reintegrating difficulty.
|
Month 4
|
|
Well-being Inventory - Functional Status
Time Frame: Month 4
|
The Functional Status composite measure from the Well-being Inventory scores range from 1 to 5, with higher scores indicating a higher level of functioning.
|
Month 4
|
|
Depressive Symptom Index - Suicidality Subscale
Time Frame: Month 4
|
Reported as count of participants with no suicidal ideation
|
Month 4
|
|
Columbia Suicide Severity Rating Scale
Time Frame: Month 4
|
Reported as count of participants with no suicidal ideation
|
Month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of VA healthcare visits (primary care, mental health, or other specialty care visits)
Time Frame: Month 4
|
Number of VA healthcare visits (primary care, mental health, or other specialty care visits) completed during the first four months of study participation, with higher number of visits indicating higher VA care utilization.
|
Month 4
|
|
Number of VA healthcare visits (primary care, mental health, or other specialty care visits)
Time Frame: Month 9
|
Number of VA healthcare visits (primary care, mental health, or other specialty care visits) completed during study participation (9 months), with higher number of visits indicating higher VA care utilization.
|
Month 9
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lauren M. Denneson, PhD, VA Portland Health Care System, Portland, OR
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Actual)
March 31, 2025
Study Completion (Actual)
March 31, 2025
Study Registration Dates
First Submitted
December 10, 2021
First Submitted That Met QC Criteria
January 5, 2022
First Posted (Actual)
January 20, 2022
Study Record Updates
Last Update Posted (Actual)
June 9, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D3704-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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