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HARPP

HARPP for Veterans with PTSD and Obesity

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What is being tested

HARPP

+ control arm for HARPP trial
Behavioral
Who is being recruted

PTSD

+ Obesity
Over 18 Years
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: January 2026

See protocol details

Summary

Principal SponsorVA Office of Research and Development
Study ContactNadiyah Sulayman, BA
Last updated: June 8, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: January 5, 2026Actual 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.

Official TitleTesting an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial 
Principal SponsorVA Office of Research and Development
Study ContactNadiyah Sulayman, BA
Last updated: June 8, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
PTSD
Obesity
Criteria
4 inclusion criteria required to participate
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
7 exclusion criteria prevent from participating
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

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
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.
Group II
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.
Study Objectives
Primary Objectives

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.

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.
Secondary Objectives

Body weight change from baseline to 6 months (measured by assessing weight on a study scale at baseline and 6 months following baseline) will be compared between intervention and control groups.

PTSD symptom severity will be measured via self-report on the PTSD Checklist for DSM-5 at baseline and 6 months following baseline. Symptom severity change from baseline to 6 months will be compared between intervention and control groups.

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
Suspended
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattle, United StatesSee the location
Recruiting soonOne Study Center