NCT07010757Recruiting
Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
Obesity and post-traumatic stress disorder (PTSD) are common among Veterans. PTSD increases risk for obesity, impacting functioning, health, quality of life, and premature mortality. Use of proven treatments for PTSD and obesity in VA is low. Furthermore, Veterans with PTSD lose less weight than those without PTSD in VA's national weight management program. Based on pilot work, an integrated treatment that combines PTSD and weight management care-using behavioral and pharmacologic approaches-may improve weight and PTSD. Whether it improves these outcomes more than standard VA care is unknown, which is the focus of this study. The study also seeks to understand factors that would interfere with and facilitate implementing the program in VA if it is effective. This Veteran-centered program may be a more efficient and effective treatment for Veterans with PTSD and obesity, addressing both physical and mental health.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- First submitted
- 30 May 2025
- Start date
- 2 Mar 2026
- Primary completion date
- 2 Mar 2029
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Obesity
- NCT number
- NCT07010757
What you commit to
- Study type: Interventional
- Planned participants: 182
- From 2 Mar 2026 to the primary completion date, 2 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had bariatric surgery in past 6 months or plans to receive it in next 12 months
Other illness
- Any history of a bulimia diagnosis and/or meets criteria for bulimia
- Cannot participate due to a) acute substance use, mental health, or medical exacerbation or b) at least moderate neurologic conditions, e.g., dementia
Other
- Not fluent in English, severe hearing loss, no phone access
- Recent MOVE! or CPT participation (2 visits in past 2 months)
- At least 1 fill of AOM in the past 90 days
- Current pregnancy
- Current weight 600lbs or greater to accommodate study scale restrictions
- Unable to complete a standing weight and height measurement to accommodate study scale restrictions
Who the study is looking for
- Veteran adult
- Current PTSD Diagnosis per the revised Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R)
- Obesity: BMI of 30 kg/m2
- Enrolled in VA Puget Sound primary care to ensure safety and facilitate HARPP's medication component
- Willing to do intervention or control and assessments
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.