NCT07010757 Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
| NCT ID | NCT07010757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2029-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 182 participants in total. It began in 2026-03-02 with a primary completion date of 2029-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Katherine D Hoerster, PhD MPH BA
PRINCIPAL INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Frequently Asked Questions
Who can join the NCT07010757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07010757 currently recruiting?
Yes, NCT07010757 is actively recruiting participants. Contact the research team at michelle.upham@va.gov for enrollment information.
Where is the NCT07010757 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT07010757 clinical trial?
NCT07010757 is sponsored by VA Office of Research and Development. The principal investigator is Katherine D Hoerster, PhD MPH BA at VA Puget Sound Health Care System Seattle Division, Seattle, WA. The trial plans to enroll 182 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.