NCT Number: NCT07010757
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98108-1532, United States
Location status: Recruiting
Amy Marsh
CONTACT
Christopher Click
CONTACT
Katherine D Hoerster, PhD MPH BA
PRINCIPAL_INVESTIGATOR
Background: Obesity and post-traumatic stress disorder (PTSD) are highly prevalent among Veterans. PTSD increases risk for obesity and related conditions, in part due to PTSD symptoms interfering with physical activity and healthy diet. VA offers effective evidence-based behavioral and pharmacologic weight management and PTSD treatments, but utilization is low. Veterans with PTSD also lose less weight than those without mental health conditions in VA's MOVE! behavioral weight management program. In response, the investigators developed HARPP-an integrated weight and PTSD treatment-to promote improved access, efficiency, and outcomes. HARPP is a manualized 16-session individually-delivered treatment that combines VA's MOVE! behavioral weight management program and cognitive processing therapy (CPT), enhanced to address obesity-PTSD intersections, and medication review and management. 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. In a pilot of HARPP among 7 Veterans, participants reported high satisfaction, and experienced substantial weight loss and PTSD symptom reduction. HARPP effectiveness must be tested in a randomized controlled trial (RCT).
Significance/Impact: The study aligns with VA and HSR priorities, given its focus on meaningful Veteran engagement to develop and test a novel, Veteran-centered, whole health intervention focused on improving access and outcomes for Veterans with PTSD, a priority VA population. This study's identification of implementation determinants would place effectiveness findings in context and facilitate translation to clinical care if HARPP is effective. This study will also yield insights about how weight management and PTSD care can be enhanced broadly. For example, the medication protocol and templates could be of use broadly in VA.
Innovation: HARPP is the first integrated treatment designed to address obesity and PTSD simultaneously.
Specific Aims: The investigators will randomize 182 Veterans with PTSD and obesity to control (standard CPT, referral to standard MOVE!, and one non-visit consult medication review) or intervention (HARPP, described above) to address the following aims: 1) Test whether intervention participants have greater absolute weight loss in pounds and PTSD symptom reduction relative to controls at 6 (secondary outcomes) and 12 months (co-primary outcomes); 2) Assess whether taking AOM mediates the relationship between HARPP and 12-month weight loss; and 3) Assess implementation determinants (acceptability, feasibility, fidelity, and cost).
Methodology: The investigators propose to conduct a hybrid type 1 RCT among Veterans with PTSD and obesity to test the primary hypothesis that HARPP participants will have greater 12-month absolute weight loss in pounds and PTSD symptom reduction relative to Veterans enrolled in the control group. The Veteran Engagement Group will consult throughout the study, ensuring Veteran-centeredness.
Next Steps/Implementation: If trial findings suggest HARPP is effective, the study team will partner with Veterans and operational leaders to develop a HARPP implementation package that will be tested in a multi-site hybrid type 2 trial, findings of which will inform broad VA implementation. Implementation activities would be coordinated with existing local, VISN, and national operational partners. If HARPP is not effective, Aims 2 and 3 will help understand how Veterans with PTSD and obesity could be better supported in the future.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In HARPP, MOVE! and CPT are delivered in up to 16 individual psychotherapy sessions. While all CPT content is included, it is slightly tailored to address factors that interfere with health behavior change (e.g., hypervigilance that hinders community-based physical activity). All MOVE! materials are included; MOVE! uses cognitive-behavioral techniques and autonomy-supporting counseling to promote physical activity and healthy eating. HARPP targets other PTSD-related barriers to recovery and healthy lifestyles by promoting sleep and relationship quality, and community engagement. HARPP participants receive at least one medication management consultation (review by clinician and telephone session) focused on currently may cause weight gain and AOM options. When relevant and based upon Veteran interest, medications are changed or prescribed, in coordination with the Veteran's psychiatric and primary care teams.
Participants in the control condition will receive the following:
Time frame: 12 months post-baseline
Body weight will be measured on a study scale at baseline and 12 months following baseline. This study's co-primary aim is to test whether intervention participants have greater 12-month weight loss, relative to controls.
Time frame: 12 months post-baseline
PTSD symptom severity will be measured via self-report on the PTSD Checklist for DSM-5 at baseline and 12 months following baseline. This study's co-primary aim is to test whether intervention participants have greater 12-month PTSD symptom reduction, relative to controls.
Time frame: 6 months post-baseline
Body weight change from baseline to 6 months (measured by assessing weight on a study scale at baseline and 6 months following baseline) will be compared between intervention and control groups.
Time frame: 6 months post-baseline
PTSD symptom severity will be measured via self-report on the PTSD Checklist for DSM-5 at baseline and 6 months following baseline. Symptom severity change from baseline to 6 months will be compared between intervention and control groups.
Time frame: 6 months post-baseline
PTSD symptom severity will be measured via a clinician-administered measure, the CAPS-5-R as a secondary outcome: change in absolute PTSD symptom severity at 6 months as measured with the CAPS-5.
Time frame: 12 months post-baseline
Whether or not (yes vs. no) participant had at least 1 pharmacy fill of Anti-obesity medication in the 12 months post-baseline, per VA pharmacy data. Will be assessed as a mediator in an exploratory analysis.
Contact information is provided by the study sponsor or research team.
Katherine D Hoerster, PhD MPH BA
CONTACT
Michelle L Upham, MSW
CONTACT
VA Office of Research and Development
Fed
Acronym: HARPP
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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