VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
NCT Number: NCT05755100
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: change from baseline to 6 months
in person weight taken during research visit
Time frame: change from baseline to 6 months
PCL-5 (self-reported)
Time frame: change from baseline to 6 months
PhQ-8 (self-reported)
Time frame: change from baseline to 6 months
Insomnia severity index (self-reported)
Time frame: change from baseline to 6 months
Starting the Conversation (self-reported)
Time frame: change from baseline to 6 months
Modified based on Sallis et al measure (self-reported)
Time frame: change from baseline to 6 months
Internalized weight bias measure (self-reported)
Time frame: change from baseline to 6 months
Sf-12 (self-reported)
Time frame: change from baseline to 6 months
In person, taken during research visit
Time frame: change from baseline to 6 months
In person, taken during research visit
Time frame: change from baseline to 6 months
In person, taken during research visit
Time frame: change from baseline to 6 months
In person, bloodwork taken during research visit
Time frame: change from baseline to 6 months
In person, bloodwork taken during research visit
Time frame: change from baseline to 6 months
In person, bloodwork taken during research visit
Time frame: change from baseline to 6 months
In person, bloodwork taken during research visit
Time frame: change from baseline to 6 months
In person, bloodwork taken during research visit
VA Puget Sound Health Care System
Fed
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