HARPPHARPP for Veterans with PTSD and Obesity
HARPP
+ control arm for HARPP trial
Treatment Study
Summary
Study start date: January 5, 2026
Actual date on which the first participant was enrolled.This study aims to address the challenges faced by Veterans who have both obesity and post-traumatic stress disorder (PTSD). These conditions are common among Veterans and can negatively affect physical activity and diet, making it hard for them to manage their weight. The VA offers treatments for both obesity and PTSD, but not many use them, and those with PTSD tend to lose less weight compared to others. To tackle this, a program called HARPP has been developed. It combines weight management and PTSD therapy, also reviewing medications that might contribute to weight gain. Initial tests showed that Veterans who participated were satisfied and saw improvements in both weight and PTSD symptoms. This study is essential as it seeks to test HARPP's effectiveness in a larger group, potentially leading to better health outcomes for Veterans if successful. Participants in this study will be randomly assigned to one of two groups: one will receive the HARPP program, while the other will receive standard treatments currently available. The HARPP program includes 16 individual sessions combining weight management and PTSD therapy, with medication reviews to potentially adjust prescriptions that affect weight. The study will monitor participants over 6 to 12 months, focusing on their weight loss and reduction in PTSD symptoms. Researchers will look at how well the program is accepted, how easy it is to implement, and the costs involved. If HARPP proves successful, it could lead to broader use within the VA to help Veterans with these challenging conditions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.182 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, United StatesSee the location