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Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The latter focuses on identifying obesogenic medications that could be changed and eligibility for anti-obesity medications (AOM) through chart review, \~2-3 virtual visits with an obesity specialist, and close coordination with Veterans' care teams."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests care that combines PTSD treatment and weight management for adult Veterans with both conditions. PTSD is a mental health condition that can follow a traumatic event. The study compares this combined care, using behavior changes and medicines, with usual VA care.

Obesity and post-traumatic stress disorder (PTSD) are common among Veterans. PTSD increases risk for obesity, impacting functioning, health, quality of life, and premature mortality. Use of proven treatments for PTSD and obesity in VA is low. Furthermore, Veterans with PTSD lose less weight than those without PTSD in VA's national weight management program. Based on pilot work, an integrated treatment that combines PTSD and weight management care-using behavioral and pharmacologic approaches-may improve weight and PTSD. Whether it improves these outcomes more than standard VA care is unknown, which is the focus of this study. The study also seeks to understand factors that would interfere with and facilitate implementing the program in VA if it is effective. This Veteran-centered program may be a more efficient and effective treatment for Veterans with PTSD and obesity, addressing both physical and mental health.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult Veteran.
  • You have a current PTSD diagnosis confirmed by the study's clinical test.
  • You have obesity, with a body mass index (BMI) of 30. BMI is a measure based on height and weight.
  • You receive primary care at VA Puget Sound.
  • You are willing to join either study group and complete study checkups.

Who can't join

  • You are not fluent in English, have severe hearing loss, or have no phone access.
  • You had 2 visits in the past 2 months for MOVE! weight management or CPT, a PTSD therapy.
  • You had weight-loss surgery in the past 6 months or plan to have it in the next 12 months.
  • You filled a prescription for a weight-loss medicine in the past 90 days.
  • You are pregnant.
  • You have ever been diagnosed with bulimia, an eating disorder, or meet the criteria for it now.
  • You cannot take part because of a sudden or worsening substance use, mental health, or medical problem, or a moderate or worse brain or nerve condition, such as dementia.
  • You weigh 600 pounds or more, or cannot stand for height and weight measurements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Veteran adult 2. Current PTSD Diagnosis per the revised Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R) 3. Obesity: BMI of 30 kg/m2 4. Enrolled in VA Puget Sound primary care to ensure safety and facilitate HARPP's medication component 5. Willing to do intervention or control and assessments Exclusion Criteria: 1. Not fluent in English, severe hearing loss, no phone access 2. Recent MOVE! or CPT participation (2 visits in past 2 months) 3. Had bariatric surgery in past 6 months or plans to receive it in next 12 months 4. At least 1 fill of AOM in the past 90 days 5. Current pregnancy 6. Any history of a bulimia diagnosis and/or meets criteria for bulimia 7. Cannot participate due to a) acute substance use, mental health, or medical exacerbation or b) at least moderate neurologic conditions, e.g., dementia 8. Current weight 600lbs or greater to accommodate study scale restrictions 9. Unable to complete a standing weight and height measurement to accommodate study scale restrictions

Study sites (1)

WA