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

Status: Recruiting

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

Obesity and post-traumatic stress disorder (PTSD) are common among Veterans. 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 low. Furthermore, Veterans with PTSD lose less weight than those without PTSD in VA's national weight management program. Based on pilot work, an integrated treatment that combines PTSD and weight management care-using behavioral and pharmacologic approaches-may improve weight and PTSD. Whether it improves these outcomes more than standard VA care is unknown, which is the focus of this study. The study also seeks to understand factors that would interfere with and facilitate implementing the program in VA if it is effective. This Veteran-centered program may be a more efficient and effective treatment for Veterans with PTSD and obesity, addressing both physical and mental health.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Veteran adult

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

• Obesity: BMI of 30 kg/m2

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

• Willing to do intervention or control and assessments

Locations

United States

Washington

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

RECRUITING

Seattle

Contact Information

Primary

Michelle L Upham, MSW

michelle.upham@va.gov

(206) 277-1961

Backup

Katherine D Hoerster, PhD MPH BA

Katherine.Hoerster@va.gov

(206) 277-4203

Time Frame

Start Date: 2026-03-02

Estimated Completion Date: 2029-06-30

Participants

Target number of participants: 182

Treatments

Active_comparator: control group

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.

Experimental: intervention (HARPP)

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.

Related Therapeutic Areas

Obesity

Post-Traumatic Stress Disorder (PTSD)

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