PTSDNCT05755100
I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD
A study testing I MOVE!+UP in people with PTSD and Overweight and Obesity, run by VA Puget Sound Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Overweight and Obesity
- What is being tested?
- I MOVE!+UP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- - 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
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
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.
Read the 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.
- Conditions
- PTSD, Overweight and Obesity
- Being tested
- I MOVE!+UP
- Medical subject headings
- Stress Disorders, Post-Traumatic, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I MOVE!+UPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater. | Other | Single arm pilot trial. Receives: Behavioral: I MOVE!+UP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
in person weight taken during research visit
Measured: change from baseline to 6 months
PTSD symptoms
PCL-5 (self-reported)
Measured: change from baseline to 6 months
Secondary outcomes (14)
Depression symptoms
PhQ-8 (self-reported)
Measured: change from baseline to 6 months
Insomnia severity
Insomnia severity index (self-reported)
Measured: change from baseline to 6 months
Diet quality
Starting the Conversation (self-reported)
Measured: change from baseline to 6 months
Social support for physical activity and healthy eating
Modified based on Sallis et al measure (self-reported)
Measured: change from baseline to 6 months
Internalized weight bias
Internalized weight bias measure (self-reported)
Measured: change from baseline to 6 months
Health-related quality of life
Sf-12 (self-reported)
Measured: change from baseline to 6 months
Waist circumference
In person, taken during research visit
Measured: change from baseline to 6 months
Blood pressure (systolic)
In person, taken during research visit
Measured: change from baseline to 6 months
Blood pressure (diastolic)
In person, taken during research visit
Measured: change from baseline to 6 months
Total cholesterol
In person, bloodwork taken during research visit
Measured: change from baseline to 6 months
LDL cholesterol
In person, bloodwork taken during research visit
Measured: change from baseline to 6 months
HDL cholesterol
In person, bloodwork taken during research visit
Measured: change from baseline to 6 months
Triglycerides
In person, bloodwork taken during research visit
Measured: change from baseline to 6 months
HbA1C
In person, bloodwork taken during research visit
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start12 Jan 2023
- Primary completion1 Mar 2024
- Study completion1 Oct 2024
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.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled pilot trial.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Katherine Hoerster, VA Puget Sound Health Care System
- Investigators
- Katherine L Hoerster, PhD, MPH, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755100
- Sponsor's protocol ID
- 1670114
- Status last verified
- Nov 2024
- First submitted
- 8 Feb 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT05755100
- Acronym / sponsor ID
- 1670114
- Conditions
- PTSD, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Mar 2023 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled pilot trial.
| Arm | Type | Receives |
|---|---|---|
| Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater. | Other | Behavioral: I MOVE!+UPSingle arm pilot trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - U.S. military Veteran
- - 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
Key exclusion criteria (6 listed)
- - 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.
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 |
|---|---|---|
| I MOVE!+UPAn 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. | Behavioural | Pilot study of I MOVE!+UP among Veterans with PTSD and BMI of 30 or greater. |
Primary outcome
Weight
Time frame: change from baseline to 6 months
in person weight taken during research visit
PTSD symptoms
Time frame: change from baseline to 6 months
PCL-5 (self-reported)
14 secondary outcomes
Depression symptoms
Time frame: change from baseline to 6 months
Insomnia severity
Time frame: change from baseline to 6 months
Diet quality
Time frame: change from baseline to 6 months
Social support for physical activity and healthy eating
Time frame: change from baseline to 6 months
Internalized weight bias
Time frame: change from baseline to 6 months
Health-related quality of life
Time frame: change from baseline to 6 months
Waist circumference
Time frame: change from baseline to 6 months
Blood pressure (systolic)
Time frame: change from baseline to 6 months
Blood pressure (diastolic)
Time frame: change from baseline to 6 months
Total cholesterol
Time frame: change from baseline to 6 months
LDL cholesterol
Time frame: change from baseline to 6 months
HDL cholesterol
Time frame: change from baseline to 6 months
Triglycerides
Time frame: change from baseline to 6 months
HbA1C
Time frame: change from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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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. This study is not recruiting at the moment.
Katherine L Hoerster, PhD, MPH principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I MOVE!+UP in people with PTSD and Overweight and Obesity, run by VA Puget Sound Health Care System 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 6 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: finished, as of the sponsor's last update on 6 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: change from baseline to 6 months). 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 6 Nov 2024.