I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD

NCT05755100 | Completed

• 1 other identifier: 1670114
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to test I MOVE!+UP, which integrates individual evidence-based psychotherapy for PTSD with behavioral weight management among Veterans with a Body Mass Index of at least 30 and meeting criteria for current PTSD. Participants will continue receiving routine primary care and psychiatric care management as indicated, in coordination with the I MOVE!+UP therapist. This study is being conducted to see whether I MOVE!+UP holds promise as a treatment for commonly co-occurring PTSD and high Body Mass Index. Participation will involve attending up to 16 psychotherapy visits that last approximately 1-2 hours over 6 months and attending 2 study assessment visits that last approximately 1-2 hours at enrollment and 6 months. Active participation will take up to approximately 6 months.

Conditions

PTSD; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Weight

  in person weight taken during research visit

  change from baseline to 6 months

• PTSD symptoms

  PCL-5 (self-reported)

  change from baseline to 6 months

Secondary Outcomes (14)

• Depression symptoms

  change from baseline to 6 months

• Insomnia severity

  change from baseline to 6 months

• Diet quality

  change from baseline to 6 months

• Social support for physical activity and healthy eating

  change from baseline to 6 months

• Internalized weight bias

  change from baseline to 6 months

Study Arms (1)

Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater.

OTHER

Single arm pilot trial.

Behavioral: I MOVE!+UP

Interventions

I MOVE!+UP BEHAVIORAL

An individual psychotherapy that integrates behavioral weight management with evidence-based psychotherapy for PTSD (Cognitive Processing Therapy) for up to 6 months, augmented with evidence-based psychiatric and weight management medication management.

Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- U.S. military Veteran
• PTSD Diagnosis: standard criteria for PTSD Checklist for DSM-5 (PCL-5): lifetime.
• \- Experience of trauma, a score of ≥33, and meets criteria for the symptom domains.
• \- Body Mass Index (BMI) of ≥ 30 kg/m2.
• \- Willing to participate in all intervention and assessment activities

You may not qualify if:

• \- Not fluent in English, severe hearing loss, no phone access.
• \- Current MOVE! participation (at least 2 sessions in the past 3 months.)
• \- Current PTSD psychotherapy participation (at least 2 PE or CPT sessions in the past 3 months.)
• \- Past year bariatric surgery or planning to have bariatric surgery in next 6 months.
• \- Current pregnancy.
• \- Based on clinical judgment, would be unable to participate because of a) acutely exacerbated substance use, mental health, or chronic medical conditions or b) moderate to severe chronic, progressive neurologic conditions such as Dementia.

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Overweight; Obesity

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine L Hoerster, PhD, MPH

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Uncontrolled pilot trial.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 6, 2023
• Study Start: January 12, 2023
• Primary Completion: March 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

US (1)