Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 30, 2025
Trial Information
Current as of August 20, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment approach for Veterans who are dealing with both post-traumatic stress disorder (PTSD) and obesity. The goal is to see if a combined program that addresses both mental health (PTSD) and physical health (weight management) can help Veterans lose weight and improve their PTSD symptoms more effectively than the standard care currently available. This study also aims to find out what factors might help or hinder the implementation of this new program in Veterans Affairs (VA) settings if it proves to be successful.
To participate in this trial, Veterans need to have a current PTSD diagnosis and be classified as obese, which means having a body mass index (BMI) of 30 or more. They should also be enrolled in VA primary care to ensure their safety during the study. Participants must be willing to engage in either the new treatment or a control group and undergo assessments throughout the study. It's important to note that certain individuals, such as those with severe hearing loss, recent participation in weight management programs, or a history of specific eating disorders, may not be eligible to join the trial. Overall, this study aims to provide a more effective treatment option for Veterans facing these challenging conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Current PTSD Diagnosis per Clinician-Administered PTSD Scale for DSM-5 (CAPS)
- • Obesity: BMI of 30 kg/m2
- • Enrolled in VAPS 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
- • 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
About Va Office Of Research And Development
The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
Patients applied
Trial Officials
Katherine D Hoerster, PhD MPH BA
Principal Investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported