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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755100
• Other study ID #: 1670114
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: VA Puget Sound Health Care System
• Contact: Katherine D Hoerster, PhD, MPH
• Phone: 206-277-4203
• Email: katherine.hoerster[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• PTSD

Intervention

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.

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	in person weight taken during research visit	change from baseline to 6 months
Primary	PTSD symptoms	PCL-5 (self-reported)	change from baseline to 6 months
Secondary	Depression symptoms	PhQ-8 (self-reported)	change from baseline to 6 months
Secondary	Insomnia severity	Insomnia severity index (self-reported)	change from baseline to 6 months
Secondary	Diet quality	Starting the Conversation (self-reported)	change from baseline to 6 months
Secondary	Social support for physical activity and healthy eating	Modified based on Sallis et al measure (self-reported)	change from baseline to 6 months
Secondary	Internalized weight bias	Internalized weight bias measure (self-reported)	change from baseline to 6 months
Secondary	Health-related quality of life	Sf-12 (self-reported)	change from baseline to 6 months
Secondary	Waist circumference	In person, taken during research visit	change from baseline to 6 months
Secondary	Blood pressure (systolic)	In person, taken during research visit	change from baseline to 6 months
Secondary	Blood pressure (diastolic)	In person, taken during research visit	change from baseline to 6 months
Secondary	Total cholesterol	In person, bloodwork taken during research visit	change from baseline to 6 months
Secondary	LDL cholesterol	In person, bloodwork taken during research visit	change from baseline to 6 months
Secondary	HDL cholesterol	In person, bloodwork taken during research visit	change from baseline to 6 months
Secondary	Triglycerides	In person, bloodwork taken during research visit	change from baseline to 6 months
Secondary	HbA1C	In person, bloodwork taken during research visit	change from baseline to 6 months