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

NANot yet recruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

January 5, 2026

Primary Completion Date

January 5, 2029

Study Completion Date

June 30, 2029

Conditions
PTSDObesity
Interventions
BEHAVIORAL

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.

BEHAVIORAL

control arm for HARPP trial

"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."

Trial Locations (1)

98108-1532

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

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT07010757 - Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial | Biotech Hunter | Biotech Hunter