Integrated Treatment for PTSD and Obesity

(HARPP Trial)

Overseen By Nadiyah Sulayman, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: AOM

Disqualifiers: Bulimia, Dementia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combined treatment approach can assist Veterans dealing with both PTSD and obesity. The study will test whether this new method, which includes psychotherapy sessions and medication management (known as HARPP), is more effective than the usual care provided by the VA. Veterans with PTSD and a BMI of 30 or more, who are enrolled in VA primary care, may qualify to participate. As an unphased trial, this study provides Veterans with a unique opportunity to explore innovative treatment options that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves medication components, it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the HARPP treatment, which combines therapy and weight management for Veterans with PTSD and obesity, produced positive results in earlier tests. Veterans who participated expressed satisfaction with the program and noticed improvements in both weight and PTSD symptoms. While specific safety details for HARPP are not provided, these improvements suggest it is generally well-tolerated. The program's emphasis on personalized therapy and healthy living likely supports its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HARPP because it integrates treatment for both PTSD and obesity, addressing these conditions together rather than separately. Unlike traditional treatments that often focus on just one condition at a time, HARPP combines cognitive-behavioral therapy with strategies to promote healthy lifestyle changes, such as increased physical activity and better eating habits. It also tailors therapy to tackle PTSD-related challenges that may hinder progress, like hypervigilance, while supporting improvements in sleep, relationships, and community engagement. This comprehensive approach could lead to more effective outcomes for individuals struggling with both PTSD and obesity, a combination that's not well addressed by current standard treatments.

What evidence suggests that this trial's treatments could be effective for PTSD and obesity?

Research has shown that Veterans with PTSD tend to lose less weight than those without PTSD in the VA's weight management program. In this trial, participants in the intervention arm will receive HARPP treatment, which combines PTSD care with weight management strategies, using both behavior-focused therapy and medication. Early tests of HARPP found that Veterans were satisfied with the results and experienced improvements in both weight and PTSD symptoms. This combined approach addresses PTSD-related issues that hinder healthy lifestyle changes, such as hypervigilance. Early evidence suggests that HARPP could be a more effective and efficient way to manage both PTSD and obesity in Veterans. Meanwhile, participants in the control group will receive standard care, including referral to MOVE! and standard CPT sessions. ^{1 3 4 6 7}

Who Is on the Research Team?

Katherine D Hoerster, PhD MPH BA

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for Veterans with both PTSD and obesity, who may benefit from a new treatment that tackles both issues together. Participants should not be currently receiving other specific treatments for these conditions.

Inclusion Criteria

I have been diagnosed with PTSD by a professional.

My BMI is 30 or higher.

Enrolled in VAPS primary care to ensure safety and facilitate HARPP's medication component

Exclusion Criteria

I have attended at least 2 MOVE! or CPT sessions in the last 2 months.

I have had one prescription for acute otitis media filled in the last 90 days.

Cannot participate due to a) acute substance use, mental health, or medical exacerbation or b) at least moderate neurologic conditions, e.g., dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the HARPP intervention, which includes up to 16 individual psychotherapy sessions combining MOVE! and CPT, along with medication management consultations.

16 weeks

16 visits (virtual or in-person)

Follow-up

Participants are monitored for weight change and PTSD symptom severity at 6 and 12 months post-baseline.

12 months

2 visits (in-person) at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• HARPP

Trial Overview The study is testing an integrated program called HARPP against standard VA care to see if it better improves weight management and PTSD symptoms in Veterans. It combines behavioral strategies with medication.

How Is the Trial Designed?

Group I: intervention (HARPP) Experimental Treatment 1 Intervention

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: control group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07010757?locStr=United+States&country=United+States&aggFilters=status%3A

Testing an Integrated PTSD and Weight Management ... In response, the investigators developed HARPP-an integrated weight and PTSD treatment-to promote improved access, efficiency, and outcomes.

2. patlynk.com patlynk.com/trial/NCT07010757

HARPP for Veterans with PTSD and Obesity 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 ...

3. withpower.com withpower.com/trial/phase-stress-disorders-post-traumatic-2026-4675c

Integrated Treatment for PTSD and Obesity (HARPP Trial) Furthermore, Veterans with PTSD lose less weight than those without PTSD in VA's national weight management program. Based on pilot work, an integrated ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7478932/

Development of a Tailored Behavioral Weight Loss Program ... Veterans with post-traumatic stress disorder (PTSD) lose less weight in the Veterans Affairs (VA) weight management program (MOVE!), so we developed MOVE!

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12459863/

Posttraumatic Stress Disorder and Weight Loss in Male ... indicate that veterans with a PTSD diagnosis lose significantly less weight than those not diagnosed with PTSD. However, there have been no ...

6. reporter.nih.gov reporter.nih.gov/project-details/11098319

Project Details - NIH RePORTER 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 ...

7. hsrd.research.va.gov hsrd.research.va.gov/publications/vets_perspectives/0920-MOVE-UP-Behavioral-Weight-Management-Program-for-Veterans-with-PTSD.cfm

MOVE!+UP Behavioral Weight Management Program for ... More than 70% of Veteran participants lost approximately 5% of baseline weight, with an average decrease of 14 lbs. PTSD symptom severity as measured on the ...