Integrated PTSD and weight-management program for Veterans with obesity.
Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
This program will test whether combining PTSD therapy with behavioral and medication-supported weight management helps Veterans with PTSD and obesity lose weight and reduce PTSD symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT07010757 on ClinicalTrials.gov |
What this trial studies
This randomized trial compares HARPP, a manualized 16-session individually delivered program that combines VA MOVE! behavioral weight management, cognitive processing therapy (CPT), and medication review/management, to usual VA care. HARPP includes chart review for obesogenic medications, eligibility checks for anti-obesity medications, about 2–3 virtual visits with an obesity specialist, and coordinated care with Veterans' teams. The trial builds on a small pilot (n=7) that reported high satisfaction and promising weight loss and PTSD symptom reduction. The study also collects data on barriers and facilitators to implementing HARPP across VA if it proves effective.
Who should consider this trial
Good fit: Ideal candidates are adult Veterans enrolled in VA Puget Sound primary care with current PTSD (per CAPS-5-R), a BMI of 30 kg/m2 or higher, and willingness to participate in either the integrated program or control plus study assessments.
Not a fit: Patients unlikely to benefit include those with recent bariatric surgery, recent anti-obesity medication use, current pregnancy, active substance-use or severe medical/neurologic exacerbations, bulimia, inability to complete measurements, or those not fluent in English or without phone access.
Why it matters
Potential benefit: If successful, the integrated program could help Veterans lose more weight and have larger reductions in PTSD symptoms by addressing both conditions together.
How similar studies have performed: CPT and MOVE! are evidence-based individually, and a small HARPP pilot (n=7) showed promising results, but large randomized trials of integrated PTSD-plus-weight programs are not yet available.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Veteran adult 2. Current PTSD Diagnosis per the revised Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R) 3. Obesity: BMI of 30 kg/m2 4. Enrolled in VA Puget Sound primary care to ensure safety and facilitate HARPP's medication component 5. Willing to do intervention or control and assessments Exclusion Criteria: 1. Not fluent in English, severe hearing loss, no phone access 2. Recent MOVE! or CPT participation (2 visits in past 2 months) 3. Had bariatric surgery in past 6 months or plans to receive it in next 12 months 4. At least 1 fill of AOM in the past 90 days 5. Current pregnancy 6. Any history of a bulimia diagnosis and/or meets criteria for bulimia 7. Cannot participate due to a) acute substance use, mental health, or medical exacerbation or b) at least moderate neurologic conditions, e.g., dementia 8. Current weight 600lbs or greater to accommodate study scale restrictions 9. Unable to complete a standing weight and height measurement to accommodate study scale restrictions
Where this trial is running
Seattle, Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Katherine D Hoerster, PhD MPH BA — VA Puget Sound Health Care System Seattle Division, Seattle, WA
- Study coordinator: Michelle L Upham, MSW
- Email: michelle.upham@va.gov
- Phone: (206) 277-1961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.