Testing a combined PTSD and weight program for Veterans with obesity

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult Veterans who have PTSD and obesity. It tests a program that treats both together against standard VA care.

Age

18 years or older

Sex

All sexes can join

Disease stage

Current PTSD diagnosis (confirmed with the CAPS-5-R) and obesity (BMI of 30 kg/m2)

Earlier treatment

Cannot have had recent MOVE! or CPT visits (2 visits in the past 2 months), bariatric surgery in the past 6 months, or a weight loss medicine fill in the past 90 days

Main reasons for not taking part

• Pregnant now
• Any history of bulimia, or meets criteria for bulimia
• Plans bariatric surgery in the next 12 months
• Weight of 600lbs (272 kg) or more, or cannot do a standing weight and height measurement
• Not fluent in English, severe hearing loss, or no phone access

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• control groupExisting treatment, for comparison

  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.

  Treatment: control arm for HARPP trial

• intervention (HARPP)Treatment being tested

  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.

  Treatment: HARPP