PTSDHARPPNCT07010757
Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
A study testing HARPP in people with PTSD and Obesity, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- HARPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran adult
- Current PTSD Diagnosis per the revised Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R)
- Obesity: BMI of 30 kg/m2
- Enrolled in VA Puget Sound primary care to ensure safety and facilitate HARPP's medication component
- Willing to do intervention or control and assessments
Who cannot join
- Not fluent in English, severe hearing loss, no phone access
- Recent MOVE! or CPT participation (2 visits in past 2 months)
- Had bariatric surgery in past 6 months or plans to receive it in next 12 months
- At least 1 fill of AOM in the past 90 days
- Current pregnancy
- Any history of a bulimia diagnosis and/or meets criteria for bulimia
Show all 9Show fewer
- Cannot participate due to a) acute substance use, mental health, or medical exacerbation or b) at least moderate neurologic conditions, e.g., dementia
- Current weight 600lbs or greater to accommodate study scale restrictions
- Unable to complete a standing weight and height measurement to accommodate study scale restrictions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Amy Marsh, 206-764-2670, amy.marsh@va.gov
Christopher Click, (206) 277-2155, christopher.click@va.gov
About this study
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.
Read the detailed description
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.
- Being tested
- HARPP, control arm for HARPP trial
- Keywords
- Veteran, behavioral weight management, cognitive processing therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARPPBehavioural
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.
control arm for HARPP trialBehavioural
Participants in the control condition will receive the following:
- Referral to MOVE!; they will select a MOVE! that fits their schedule (at VAPS MOVE! is a 12-week group).
- Standard CPT in 60-minute individual sessions, delivered by 4 CPT-trained psychotherapists (different therapists than intervention arm therapists to avoid contamination).
- One non-visit consult medication review using the same procedures and template outlined above. After the non-visit consult, the Dr. will alert the Veteran's relevant usual care team member(s) via the non-visit consult template in the medical record. They will not have direct contact with control participants, but the study team will monitor for safety following any medication changes.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Participants in the control condition will receive the following:
1. Referral to MOVE!; they will select a MOVE! that fits their schedule (at VAPS MOVE! is a 12-week group).
2. Standard CPT in 60-minute individual sessions, delivered by 4 CPT-trained psychotherapists (different therapists than intervention arm therapists to avoid contamination).
3. One non-visit consult medication review using the same procedures and template outlined above. After the non-visit consult, the Dr. will alert the Veteran's relevant usual care team member(s) via the non-visit consult template in the medical record. They will not have direct contact with control participants, but the study team will monitor for safety following any medication changes. Receives: Behavioral: control arm for HARPP trial |
| intervention (HARPP) | Experimental | 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. Receives: Behavioral: HARPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month absolute weight change in pounds
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.
Measured: 12 months post-baseline
12-month absolute PTSD symptom severity change
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.
Measured: 12 months post-baseline
Secondary outcomes (3)
6-month absolute weight change in pounds
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.
Measured: 6 months post-baseline
6-month absolute PTSD symptom severity change (PCL-5)
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.
Measured: 6 months post-baseline
6-month absolute PTSD symptom severity change (CAPS-5-R)
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.
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start2 Mar 2026
- Primary completion2 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Testing an integrated treatment that combines PTSD and weight management care, using behavioral and pharmacologic approaches, relative to usual care in a randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Katherine D Hoerster, PhD MPH BA, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010757
- Sponsor's protocol ID
- IIR 24-046
- Other IDs
- HX003961-01A1
- Acronym
- HARPP
- Status last verified
- Mar 2026
- First submitted
- 30 May 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
- ClinicalTrials.gov ID
- NCT07010757
- Acronym / sponsor ID
- HARPP / IIR 24-046
- Keywords
- Veteran, behavioral weight management, cognitive processing therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 2 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Testing an integrated treatment that combines PTSD and weight management care, using behavioral and pharmacologic approaches, relative to usual care in a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: control arm for HARPP trialParticipants in the control condition will receive the following: 1. Referral to MOVE!; they will select a MOVE! that fits their schedule (at VAPS MOVE! is a 12-week group). 2. Standard CPT in 60-minute individual sessions, delivered by 4 CPT-trained psychotherapists (different therapists than intervention arm therapists to avoid contamination). 3. One non-visit consult medication review using the same procedures and template outlined above. After the non-visit consult, the Dr. will alert the Veteran's relevant usual care team member(s) via the non-visit consult template in the medical record. They will not have direct contact with control participants, but the study team will monitor for safety following any medication changes. |
| intervention (HARPP) | Experimental | Behavioral: HARPPIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran adult
- Current PTSD Diagnosis per the revised Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R)
- Obesity: BMI of 30 kg/m2
- Enrolled in VA Puget Sound primary care to ensure safety and facilitate HARPP's medication component
- Willing to do intervention or control and assessments
Key exclusion criteria (9 listed)
- Not fluent in English, severe hearing loss, no phone access
- Recent MOVE! or CPT participation (2 visits in past 2 months)
- Had bariatric surgery in past 6 months or plans to receive it in next 12 months
- At least 1 fill of AOM in the past 90 days
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HARPPIn 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. | Behavioural | intervention (HARPP) |
| control arm for HARPP trialParticipants in the control condition will receive the following: 1. Referral to MOVE!; they will select a MOVE! that fits their schedule (at VAPS MOVE! is a 12-week group). 2. Standard CPT in 60-minute individual sessions, delivered by 4 CPT-trained psychotherapists (different therapists than intervention arm therapists to avoid contamination). 3. One non-visit consult medication review using the same procedures and template outlined above. After the non-visit consult, the Dr. will alert the Veteran's relevant usual care team member(s) via the non-visit consult template in the medical record. They will not have direct contact with control participants, but the study team will monitor for safety following any medication changes. | Behavioural | control group |
Primary outcome
12-month absolute weight change in pounds
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.
12-month absolute PTSD symptom severity change
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.
3 secondary outcomes
6-month absolute weight change in pounds
Time frame: 6 months post-baseline
6-month absolute PTSD symptom severity change (PCL-5)
Time frame: 6 months post-baseline
6-month absolute PTSD symptom severity change (CAPS-5-R)
Time frame: 6 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine D Hoerster, PhD MPH BA principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARPP in people with PTSD and Obesity, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle L Upham, MSW ((206) 277-1961, michelle.upham@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month absolute weight change in pounds (time frame: 12 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.