Clinical trial NCT05755100: I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD
Official title: I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Overweight and Obesity
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
First posted: 2023-03-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled pilot trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight
timeFrame: change from baseline to 6 months
measure: PTSD symptoms
timeFrame: change from baseline to 6 months
Secondary outcomes:
measure: Depression symptoms
timeFrame: change from baseline to 6 months
measure: Insomnia severity
timeFrame: change from baseline to 6 months
measure: Diet quality
timeFrame: change from baseline to 6 months
measure: Social support for physical activity and healthy eating
timeFrame: change from baseline to 6 months
measure: Internalized weight bias
timeFrame: change from baseline to 6 months
measure: Health-related quality of life
timeFrame: change from baseline to 6 months
measure: Waist circumference
timeFrame: change from baseline to 6 months
measure: Blood pressure (systolic)
timeFrame: change from baseline to 6 months
measure: Blood pressure (diastolic)
timeFrame: change from baseline to 6 months
measure: Total cholesterol
timeFrame: change from baseline to 6 months
measure: LDL cholesterol
timeFrame: change from baseline to 6 months
measure: HDL cholesterol
timeFrame: change from baseline to 6 months
measure: Triglycerides
timeFrame: change from baseline to 6 months
measure: HbA1C
timeFrame: change from baseline to 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Katherine L Hoerster, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: