NCT07010757

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Jun 2029

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2029

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

May 30, 2025

Last Update Submit

March 17, 2026

Conditions

PTSDObesity

Keywords

Veteranbehavioral weight managementcognitive processing therapy

Outcome Measures

Primary Outcomes (2)

  • 12-month absolute weight change in pounds

    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.

    12 months post-baseline

  • 12-month absolute PTSD symptom severity change

    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.

    12 months post-baseline

Secondary Outcomes (3)

  • 6-month absolute weight change in pounds

    6 months post-baseline

  • 6-month absolute PTSD symptom severity change (PCL-5)

    6 months post-baseline

  • 6-month absolute PTSD symptom severity change (CAPS-5-R)

    6 months post-baseline

Other Outcomes (1)

  • 12-month anti-obesity medication prescription

    12 months post-baseline

Study Arms (2)

control group

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.

Behavioral: control arm for HARPP trial

intervention (HARPP)

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.

Behavioral: HARPP

Interventions

HARPPBEHAVIORAL

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.

intervention (HARPP)
control arm for HARPP trialBEHAVIORAL

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.

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • At least 1 fill of AOM in the past 90 days
  • Current pregnancy
  • Any history of a bulimia diagnosis and/or meets criteria for bulimia
  • Cannot participate due to a) acute substance use, mental health, or medical exacerbation or b) at least moderate neurologic conditions, e.g., dementia
  • Current weight 600lbs or greater to accommodate study scale restrictions
  • Unable to complete a standing weight and height measurement to accommodate study scale restrictions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seattle, Washington, 98108-1532, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticObesity

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Katherine D Hoerster, PhD MPH BA

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle L Upham, MSW

CONTACT

(206) 277-1961michelle.upham@va.gov

Katherine D Hoerster, PhD MPH BA

CONTACT

(206) 277-4203Katherine.Hoerster@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Staff will not be able to predict treatment assignment at the point of randomization. Assessors, and biostatisticians will be masked until after 12-month data collection.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Testing an integrated treatment that combines PTSD and weight management care, using behavioral and pharmacologic approaches, relative to usual care in a randomized controlled trial.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

March 2, 2026

Primary Completion (Estimated)

March 2, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)