- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711172
Assessing the Feasibility of VA Whole Health Coaching for Veterans With Complex Health Concerns
February 10, 2026 updated by: War Related Illness and Injury Study Center
Assessing the Feasibility and Acceptability of VA Whole Health Coaching for Veterans With Complex Health Concerns
This study examines the impact of a VA Whole Health coaching program aimed at improving Veteran's health and well-being by increasing healthy lifestyle behaviors in treatment-seeking Veterans receiving care at the DC and CA War Related Illness and Injury Study Centers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20422
- Washington, DC Veterans Affairs Medical Center
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
•Veterans receiving a clinical evaluation at the War Related Illness and Injury Study Centers in Washington, DC or Palo Alto, California.
Exclusion Criteria:
- Current active suicidal or homicidal ideation
- Current or lifetime history of a psychiatric disorder with primary psychotic features
- Current or lifetime bipolar disorder
- Acute or unstable psychiatric condition(s) and/or chronic illnesses that would benefit from immediate referral for treatment
- Neurological disorders such as Alzheimer's disease, advanced Parkinson's disease, and unstable epilepsy
- Pregnancy
- Current exposure to trauma, or exposure to trauma in the past 3 months
- Current or within the past 30 days substance abuse or dependence (except nicotine)
- Excessive alcohol intake defined as an AUDIT score ≥ 4 for men and an AUDIT score ≥ 3 for women.
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health Coaching
|
The VA Whole Health coaching intervention will consist of seventeen, 30 to 60-minute telehealth sessions that were dispersed over seven to nine months.
Participants will work closely with a health coach to create a plan for making appropriate lifestyle changes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility (recruitment rate)
Time Frame: Through study completion, an average of 7 months
|
Calculated as the number of participants who consented into the study divided by the number of participants who were approached for study participation.
|
Through study completion, an average of 7 months
|
|
Feasibility (retention rate)
Time Frame: Through study completion, an average of 7 months
|
Calculated as a percentage for each time point (3 months and 6 months).
|
Through study completion, an average of 7 months
|
|
Feasibility (adherence rate)
Time Frame: Through study completion, an average of 7 months
|
Calculated as the number of health coaching sessions completed out of 17 total sessions.
|
Through study completion, an average of 7 months
|
|
Safety of Whole Health coaching intervention
Time Frame: Through study completion, an average of 7 months
|
Reported as the number of adverse events self-reported by participants during the intervention
|
Through study completion, an average of 7 months
|
|
Acceptability
Time Frame: Through study completion, an average of 7 months
|
Acceptability was evaluated qualitatively using feedback captured during health coaching sessions.
|
Through study completion, an average of 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RAND 36-Item Short Form Health Survey (SF-36)
Time Frame: Baseline to mid-intervention and baseline to post-intervention
|
To measure physical and mental health-related quality of life.
|
Baseline to mid-intervention and baseline to post-intervention
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline to post-intervention
|
To assess sleep quality and sleep disturbances
|
Baseline to post-intervention
|
|
Generalized Anxiety Disorder scale (GAD-7)
Time Frame: Baseline to post-intervention
|
To assess the level of anxiety symptoms
|
Baseline to post-intervention
|
|
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline to post-intervention
|
To evaluate mindfulness
|
Baseline to post-intervention
|
|
Patient Health Questionnaire-8 (PHQ8)
Time Frame: Baseline to post-intervention
|
To assess the level of depression symptoms
|
Baseline to post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rebecca McCullers, RN, NBC-HWC, War Related Illness and Injury Study Center
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)
June 3, 2021
Primary Completion (Actual)
November 10, 2025
Study Completion (Actual)
November 10, 2025
Study Registration Dates
First Submitted
November 26, 2024
First Submitted That Met QC Criteria
November 26, 2024
First Posted (Actual)
December 2, 2024
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 1592308
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
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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