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

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Overweight and Obesity
• Intervention / Treatment: Behavioral: I MOVE!+UP

Detailed Description

Post-traumatic stress disorder (PTSD), prevalent among Veterans, puts Veterans at increased risk for obesity and related conditions. Veterans with PTSD lose less weight in VA's MOVE! weight management program, due to PTSD symptoms that interfere with activity and healthy diet. In addition, many Veterans who receive evidence-based PTSD treatment remain symptomatic. A behavioral weight loss program that augments standard PTSD care and targets PTSD-related weight loss barriers called MOVE!+UP was piloted and iteratively refined among 44 overweight Veterans with PTSD, and is currently being tested in an RCT. However, not all Veterans will participate in group-based treatment and prior work on integrated tobacco cessation with individual psychotherapy was quite impactful, and was particularly well-suited for coordinating augmentative medication management using shared decision-making. As such, we propose to conduct an uncontrolled pilot of an intervention called I MOVE!+UP. It will integrate MOVE!+UP into individual evidence-based psychotherapy (i.e.., Cognitive Processing Therapy) for PTSD for up to 6 months, augmented with evidence-based psychiatric and weight management medication management coordination. If I MOVE!+UP is acceptable, feasible, and proof-of-concept outcomes demonstrate potential benefit to weight and PTSD outcomes, we will apply for large-scale funding to test it in an RCT. I MOVE!+UP integrated behavioral intervention will be led by a psychotherapist (social worker, psychologist, or trainee in those disciplines). Because this care will be delivered within the context of routine mental health care, patients will be offered the opportunity for individualized pharmacotherapy for weight loss and psychiatric symptom management as part of their care plan.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine D Hoerster, PhD, MPH; Phone Number: 206-277-4203; Email: katherine.hoerster@va.gov
• Study Contact Backup: Name: Alan D Wesley, BA; Phone Number: 206-619-3689; Email: alan.wesley@va.gov

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • Recruiting
      • VA Puget Sound Health Care System
      • Contact: Alan D Wesley, BA; Phone Number: 206-619-3689; Email: alan.wesley@va.gov
      • Contact: Study Coordinator; Phone Number: 206-764-2053

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - 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

Exclusion Criteria:

• - 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater.; Single arm pilot trial.	Behavioral: I MOVE!+UP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms	PhQ-8 (self-reported)	change from baseline to 6 months
Insomnia severity	Insomnia severity index (self-reported)	change from baseline to 6 months
Diet quality	Starting the Conversation (self-reported)	change from baseline to 6 months
Social support for physical activity and healthy eating	Modified based on Sallis et al measure (self-reported)	change from baseline to 6 months
Internalized weight bias	Internalized weight bias measure (self-reported)	change from baseline to 6 months
Health-related quality of life	Sf-12 (self-reported)	change from baseline to 6 months
Waist circumference	In person, taken during research visit	change from baseline to 6 months
Blood pressure (systolic)	In person, taken during research visit	change from baseline to 6 months
Blood pressure (diastolic)	In person, taken during research visit	change from baseline to 6 months
Total cholesterol	In person, bloodwork taken during research visit	change from baseline to 6 months
LDL cholesterol	In person, bloodwork taken during research visit	change from baseline to 6 months
HDL cholesterol	In person, bloodwork taken during research visit	change from baseline to 6 months
Triglycerides	In person, bloodwork taken during research visit	change from baseline to 6 months
HbA1C	In person, bloodwork taken during research visit	change from baseline to 6 months

Collaborators and Investigators

• Sponsor: VA Puget Sound Health Care System
• Investigators: Principal Investigator: Katherine L Hoerster, PhD, MPH, VA Puget Sound Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 1670114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No