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Completed

NCT Number: NCT05755100

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Weight

    Time frame: change from baseline to 6 months

    in person weight taken during research visit

  2. PTSD symptoms

    Time frame: change from baseline to 6 months

    PCL-5 (self-reported)

Secondary outcomes

  1. Depression symptoms

    Time frame: change from baseline to 6 months

    PhQ-8 (self-reported)

  2. Insomnia severity

    Time frame: change from baseline to 6 months

    Insomnia severity index (self-reported)

  3. Diet quality

    Time frame: change from baseline to 6 months

    Starting the Conversation (self-reported)

  4. Social support for physical activity and healthy eating

    Time frame: change from baseline to 6 months

    Modified based on Sallis et al measure (self-reported)

  5. Internalized weight bias

    Time frame: change from baseline to 6 months

    Internalized weight bias measure (self-reported)

  6. Health-related quality of life

    Time frame: change from baseline to 6 months

    Sf-12 (self-reported)

  7. Waist circumference

    Time frame: change from baseline to 6 months

    In person, taken during research visit

  8. Blood pressure (systolic)

    Time frame: change from baseline to 6 months

    In person, taken during research visit

  9. Blood pressure (diastolic)

    Time frame: change from baseline to 6 months

    In person, taken during research visit

  10. Total cholesterol

    Time frame: change from baseline to 6 months

    In person, bloodwork taken during research visit

  11. LDL cholesterol

    Time frame: change from baseline to 6 months

    In person, bloodwork taken during research visit

  12. HDL cholesterol

    Time frame: change from baseline to 6 months

    In person, bloodwork taken during research visit

  13. Triglycerides

    Time frame: change from baseline to 6 months

    In person, bloodwork taken during research visit

  14. HbA1C

    Time frame: change from baseline to 6 months

    In person, bloodwork taken during research visit

Sponsors and collaborators

Lead sponsor

VA Puget Sound Health Care System

Fed

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2023
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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