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Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• HARPP (behavioral)
• control arm for HARPP trial (behavioral)

Sponsor: VA Office of Research and Development · Participants: 182 · Started: Mar 2, 2026

Contact the study team

• Michelle L Upham, MSW · Phone: (206) 277-1961
• Katherine D Hoerster, PhD MPH BA · Phone: (206) 277-4203

Official record on ClinicalTrials.gov — NCT07010757

Locations in the U.S.

Conditions

• Post-Traumatic Stress Disorder
• Obesity

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.