NCT07010757 · VA Office of Research and Development
Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
(HARPP)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
HARPP
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.
BEHAVIORAL
control 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.
Primary outcome measures
12-month absolute weight change in pounds
Time frame: 12 months post-baseline
Body weight will be measured on a study scale at baseline and 12 months following baseline. This study's co-primary aim is to test whether intervention participants have greater 12-month weight loss, relative to controls.
12-month absolute PTSD symptom severity change
Time frame: 12 months post-baseline
PTSD symptom severity will be measured via self-report on the PTSD Checklist for DSM-5 at baseline and 12 months following baseline. This study's co-primary aim is to test whether intervention participants have greater 12-month PTSD symptom reduction, relative to controls.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Not fluent in English, severe hearing loss, no phone access
- Recent MOVE! or CPT participation (2 visits in past 2 months)
- Had bariatric surgery in past 6 months or plans to receive it in next 12 months
- At least 1 fill of AOM in the past 90 days
- Current pregnancy
- 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
- Current weight 600lbs or greater to accommodate study scale restrictions
- Unable to complete a standing weight and height measurement to accommodate study scale restrictions
Where
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations