Recruiting

HARPPHARPP for Veterans with PTSD and Obesity

What is being tested

HARPP

+ control arm for HARPP trial

Behavioral

Who is being recruted

Trauma and Stressor Related Disorders+9

+ Mental Disorders

+ Body Weight

Over 18 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: March 2026

See protocol details

Summary

Principal SponsorVA Office of Research and Development

Study ContactMichelle L Upham, MSWMore contacts

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 2, 2026

Actual date on which the first participant was enrolled.

Obesity and post-traumatic stress disorder (PTSD) are common among Veterans. PTSD can increase the risk of obesity and related conditions, as PTSD symptoms can interfere with physical activity and healthy eating. To address this, researchers have developed HARPP, a combined weight and PTSD treatment. HARPP is a 16-session individual treatment that merges VA's MOVE! weight management program and cognitive processing therapy (CPT), enhanced to address the connections between obesity and PTSD. It also includes medication review and management. This study is important because it aims to test the effectiveness of HARPP in improving access and outcomes for Veterans with PTSD, a priority population for VA. The study will involve 182 Veterans with PTSD and obesity. Participants will be randomly assigned to either the control group (standard CPT, referral to standard MOVE!, and one non-visit consult medication review) or the intervention group (HARPP). The main goals are to test if participants in the HARPP group have greater weight loss in pounds and PTSD symptom reduction at 6 and 12 months, compared to the control group. The study will also assess if taking anti-obesity medication mediates the relationship between HARPP and 12-month weight loss, and evaluate implementation determinants such as acceptability, feasibility, fidelity, and cost.

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

NCT07010757

Principal SponsorVA Office of Research and Development

Study ContactMichelle L Upham, MSWMore contacts

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

182 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

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.

Conditions

Pathology

Trauma and Stressor Related DisordersMental DisordersBody WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsStress Disorders, Post-TraumaticPathological Conditions, Signs and SymptomsStress Disorders, TraumaticOvernutritionOverweight

Criteria

5 inclusion criteria required to participate

Veteran adult

Current PTSD Diagnosis per the revised Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R)

Enrolled in VA Puget Sound primary care to ensure safety and facilitate HARPP's medication component

Obesity: BMI of 30 kg/m2

Show More Criteria

7 exclusion criteria prevent from participating

Had bariatric surgery in past 6 months or plans to receive it in next 12 months

Current weight 600lbs or greater to accommodate study scale restrictions

Unable to complete a standing weight and height measurement to accommodate study scale restrictions

Not fluent in English, severe hearing loss, no phone access

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Active Comparator

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.

Study 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

Recruiting

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, United StatesOpen VA Puget Sound Health Care System Seattle Division, Seattle, WA in Google Maps

Recruiting

One Study Center