RecruitingNot ApplicableNCT07010757

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

Sponsor

VA Office of Research and Development

Enrollment

182 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity PTSD

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combined treatment program that addresses both PTSD (post-traumatic stress disorder) and obesity at the same time for veterans — recognizing that the two conditions are closely linked and often need to be treated together. **You may be eligible if...** - You are an adult veteran - You have a current diagnosis of PTSD (confirmed by a clinical assessment) - You have obesity (BMI of 30 or above) - You receive primary care at VA Puget Sound - You are willing to take part in the intervention or comparison program **You may NOT be eligible if...** - You are not fluent in English, have severe hearing loss, or do not have phone access - You have recently participated in the VA's MOVE! weight loss or CPT PTSD programs (within the past 2 months) - You have previously had bariatric (weight loss) surgery - You have medical conditions that make weight loss interventions unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHARPP

In HARPP, MOVE! and CPT are delivered in up to 16 individual psychotherapy sessions. While all CPT content is included, it is slightly tailored to address factors that interfere with health behavior change (e.g., hypervigilance that hinders community-based physical activity). All MOVE! materials are included; MOVE! uses cognitive-behavioral techniques and autonomy-supporting counseling to promote physical activity and healthy eating. HARPP targets other PTSD-related barriers to recovery and healthy lifestyles by promoting sleep and relationship quality, and community engagement. HARPP participants receive at least one medication management consultation (review by clinician and telephone session) focused on currently may cause weight gain and AOM options. When relevant and based upon Veteran interest, medications are changed or prescribed, in coordination with the Veteran's psychiatric and primary care teams.

BEHAVIORALcontrol arm for HARPP trial

Participants in the control condition will receive the following: 1. Referral to MOVE!; they will select a MOVE! that fits their schedule (at VAPS MOVE! is a 12-week group). 2. Standard CPT in 60-minute individual sessions, delivered by 4 CPT-trained psychotherapists (different therapists than intervention arm therapists to avoid contamination). 3. One non-visit consult medication review using the same procedures and template outlined above. After the non-visit consult, the Dr. will alert the Veteran's relevant usual care team member(s) via the non-visit consult template in the medical record. They will not have direct contact with control participants, but the study team will monitor for safety following any medication changes.