Stress Disorders, Post-TraumaticPhase 1I CARE for VetNCT04383496
Increasing Activity for Veterans With PTSD
A Phase 1 study testing Physical Activity in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The proposed work will be a key step forward in fulfilling the mission of VA RR\&D to restore function and enable social reintegration for Veterans. Development of an intervention to increase physical activity may improve physical functioning for Veterans with posttraumatic stress disorder (PTSD), thus addressing an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 28 Jun 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 3 on Primary Care PTSD Screen (PC-PTSD-5)
- "yes" to 3 questions about health-related functional limitations from the Veterans RAND 36-Item Health Survey
- has device and internet access for participating in meetings by videoconference
Who cannot join
- active suicidal ideation or psychosis
- medical contraindication to participation (eg, complete paraplegia)
- self-reported impairments in 2 or more activities of daily living
- will be permanently moving out of area in next 4 months
- schizophrenia
- acute mental health crisis within the past 3 months (requiring an ED visit or hospitalization)
- routinely completing 150 minutes or more of moderate to vigorous activity per week
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Official title: I CARE for Vets: InCreasing Activity & REcovery for Veterans With PTSD
The proposed work will be a key step forward in fulfilling the mission of VA RR\&D to restore function and enable social reintegration for Veterans. Development of an intervention to increase physical activity may improve physical functioning for Veterans with posttraumatic stress disorder (PTSD), thus addressing an important gap in existing care. If demonstrated to be efficacious in a future randomized trial, this intervention could be implemented throughout VHA to improve quality of life and enable a full recovery for many Veterans with PTSD. Results from the proposed work may also advance our understanding of how to optimally incorporate mobile health technology (mHealth) with more traditional types of patient contacts, such as in-person visits and telephone calls. Effective use of mHealth may offer greater flexibility for VHA clinics looking to implement new programs. Incorporation of mHealth may also increase access to clinical services for Veterans who reside far from VHA facilities.
Read the detailed description
Veterans with posttraumatic stress disorder (PTSD) have poor physical functioning and there are no existing interventions that effectively address this problem. Our long-term goal is to develop and implement effective interventions to improve physical functioning and reduce risk for adverse health outcomes for Veterans with PTSD. The overall objectives of the proposed project are to develop and pilot test a novel intervention aimed at initiating and maintaining higher levels of physical activity for Veterans with PTSD. This new intervention will address attitudinal and behavioral barriers to increasing physical activity for Veterans with PTSD. Particularly relevant barriers for those with PTSD may include low perceived behavioral control for making positive long-term lifestyle changes and personal attitudes about the harms (vs. benefits) of physical activity.
The proposed work will meet two specific aims: 1) Adapt graded exercise therapy (GET) and incorporate motivational interviewing and mobile health technology (mHealth) to increase physical activity for Veterans with PTSD; and 2) conduct a pilot study to examine the feasibility and acceptability of the intervention for a future randomized controlled trial. To achieve Aim 1, we will develop treatment manuals, training procedures for interventionists, and processes for assessment of intervention fidelity. The intervention will use GET to increase perceived behavioral control by enhancing knowledge about appropriate activities and helping participants set appropriate and attainable daily goals for physical activity. We will also incorporate motivational interviewing techniques and mHealth to enhance positive personal attitudes about physical activity. We will work with our Veteran Engagement Panel for PTSD to refine topics and communication materials. In Aim 2, we will enroll 3 groups of 6-8 participants (18-24 total) and use a concurrent mixed-methods approach to rapidly assess feasibility and acceptability. Quantitative measures will include recruitment (proportion enrolled out of total eligible); attendance (proportion who attend 75% of in-person visits); and retention (proportion who complete post-intervention data collection). Qualitative assessment will consist of semi-structured interviews on acceptability of intervention components (eg, format and topics of in-person visits, usability of mHealth), and barriers and facilitators to attendance. At baseline, during, and post-intervention, we will also measure overall and physical functioning, and collect data on other clinical variables (PTSD symptoms, depressive symptoms, pain, fatigue, and sleep quality) to inform a future effectiveness trial.
The proposed work is innovative because it is a novel combination of GET, motivational interviewing, and mHealth to increase physical activity. It will also be the first intervention to focus on changing physical activity as a means to improving physical functioning for individuals with PTSD. Successful experiences with this program may also help participants build confidence about their general ability to make positive changes related to health, thus increasing the likelihood they will engage in (and adhere to) mental health treatments. If such synergy is ultimately demonstrated, it will open a new direction for VA RR\&D and VHA clinical care by indicating that interventions focusing on physical functioning should be more closely integrated with mental health services. Additionally, this project will be one of the first to collaborate with our Veteran Engagement Panel on PTSD research. The format of our panel is adapted from and builds upon previous models of patient stakeholder engagement. Our model addresses many of the barriers to effective stakeholder engagement, including challenges to timely recruitment of patients with relevant experiences, and lack of facilitation expertise among investigators. Completion of this project will help establish the utility of our model of Veteran stakeholder engagement for rapidly developing effective interventions with improved feasibility and acceptability. Thus, this work will enable incorporation of Veteran engagement in future VA research projects.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Physical Activity
- Keywords
- PTSD, Exercise, Physical Performance, Mobility Limitation, Wearable Electronic Devices
- Medical subject headings
- Stress Disorders, Post-Traumatic, Motor Activity, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
total participants enrolled in intervention (out of total patients identified as eligible)
Measured: 2 months
Secondary outcomes (3)
Total # Participants Completing Acceptability Interviews
Number of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance
Measured: 4 months
Attendance
Number of participants who attended 75% of session visits (3 out of 4 group sessions; 5 of 7 individual follow-up calls)
Measured: 1 month
Retention
Number of participants who complete post-intervention assessments at 4 months follow-up
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start2 Mar 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, Post-TraumaticStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention uses Graded Exercise Therapy to increase perceived behavioral control by enhancing knowledge about appropriate activities and helping participants set appropriate and attainable daily goals for physical activity. We will also incorporate motivational interviewing techniques and mHealth to enhance positive personal attitudes about physical activity.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Wei Denise Duan-Porter, MD PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383496
- Sponsor's protocol ID
- D3302-P
- Other IDs
- RX003302-01A1
- Acronym
- I CARE for Vet
- Status last verified
- Feb 2025
- First submitted
- 29 Apr 2020
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I CARE for Vets: InCreasing Activity & REcovery for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT04383496
- Acronym / sponsor ID
- I CARE for Vet / D3302-P
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Exercise, Physical Performance, Mobility Limitation, Wearable Electronic Devices
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed work will be a key step forward in fulfilling the mission of VA RR\&D to restore function and enable social reintegration for Veterans. Development of an intervention to increase physical activity may improve physical functioning for Veterans with posttraumatic stress disorder (PTSD), thus addressing an important gap in existing care. If demonstrated to be efficacious in a future randomized trial, this intervention could be implemented throughout VHA to improve quality of life and enable a full recovery for many Veterans with PTSD. Results from the proposed work may also advance our understanding of how to optimally incorporate mobile health technology (mHealth) with more traditional types of patient contacts, such as in-person visits and telephone calls. Effective use of mHealth may offer greater flexibility for VHA clinics looking to implement new programs. Incorporation of mHealth may also increase access to clinical services for Veterans who reside far from VHA facilities.
Detailed description
Veterans with posttraumatic stress disorder (PTSD) have poor physical functioning and there are no existing interventions that effectively address this problem. Our long-term goal is to develop and implement effective interventions to improve physical functioning and reduce risk for adverse health outcomes for Veterans with PTSD. The overall objectives of the proposed project are to develop and pilot test a novel intervention aimed at initiating and maintaining higher levels of physical activity for Veterans with PTSD. This new intervention will address attitudinal and behavioral barriers to increasing physical activity for Veterans with PTSD. Particularly relevant barriers for those with PTSD may include low perceived behavioral control for making positive long-term lifestyle changes and personal attitudes about the harms (vs. benefits) of physical activity.
The proposed work will meet two specific aims: 1) Adapt graded exercise therapy (GET) and incorporate motivational interviewing and mobile health technology (mHealth) to increase physical activity for Veterans with PTSD; and 2) conduct a pilot study to examine the feasibility and acceptability of the intervention for a future randomized controlled trial. To achieve Aim 1, we will develop treatment manuals, training procedures for interventionists, and processes for assessment of intervention fidelity. The intervention will use GET to increase perceived behavioral control by enhancing knowledge about appropriate activities and helping participants set appropriate and attainable daily goals for physical activity. We will also incorporate motivational interviewing techniques and mHealth to enhance positive personal attitudes about physical activity. We will work with our Veteran Engagement Panel for PTSD to refine topics and communication materials. In Aim 2, we will enroll 3 groups of 6-8 participants (18-24 total) and use a concurrent mixed-methods approach to rapidly assess feasibility and acceptability. Quantitative measures will include recruitment (proportion enrolled out of total eligible); attendance (proportion who attend 75% of in-person visits); and retention (proportion who complete post-intervention data collection). Qualitative assessment will consist of semi-structured interviews on acceptability of intervention components (eg, format and topics of in-person visits, usability of mHealth), and barriers and facilitators to attendance. At baseline, during, and post-intervention, we will also measure overall and physical functioning, and collect data on other clinical variables (PTSD symptoms, depressive symptoms, pain, fatigue, and sleep quality) to inform a future effectiveness trial.
The proposed work is innovative because it is a novel combination of GET, motivational interviewing, and mHealth to increase physical activity. It will also be the first intervention to focus on changing physical activity as a means to improving physical functioning for individuals with PTSD. Successful experiences with this program may also help participants build confidence about their general ability to make positive changes related to health, thus increasing the likelihood they will engage in (and adhere to) mental health treatments. If such synergy is ultimately demonstrated, it will open a new direction for VA RR\&D and VHA clinical care by indicating that interventions focusing on physical functioning should be more closely integrated with mental health services. Additionally, this project will be one of the first to collaborate with our Veteran Engagement Panel on PTSD research. The format of our panel is adapted from and builds upon previous models of patient stakeholder engagement. Our model addresses many of the barriers to effective stakeholder engagement, including challenges to timely recruitment of patients with relevant experiences, and lack of facilitation expertise among investigators. Completion of this project will help establish the utility of our model of Veteran stakeholder engagement for rapidly developing effective interventions with improved feasibility and acceptability. Thus, this work will enable incorporation of Veteran engagement in future VA research projects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention uses Graded Exercise Therapy to increase perceived behavioral control by enhancing knowledge about appropriate activities and helping participants set appropriate and attainable daily goals for physical activity. We will also incorporate motivational interviewing techniques and mHealth to enhance positive personal attitudes about physical activity.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical ActivityIn-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 3 on Primary Care PTSD Screen (PC-PTSD-5)
- "yes" to 3 questions about health-related functional limitations from the Veterans RAND 36-Item Health Survey
- has device and internet access for participating in meetings by videoconference
Key exclusion criteria (7 listed)
- active suicidal ideation or psychosis
- medical contraindication to participation (eg, complete paraplegia)
- self-reported impairments in 2 or more activities of daily living
- will be permanently moving out of area in next 4 months
- schizophrenia
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 |
|---|---|---|
| Physical ActivityIn-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation | Behavioural | Physical Activity |
Primary outcome
Recruitment
Time frame: 2 months
total participants enrolled in intervention (out of total patients identified as eligible)
3 secondary outcomes
Total # Participants Completing Acceptability Interviews
Time frame: 4 months
Attendance
Time frame: 1 month
Retention
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Wei Denise Duan-Porter, MD PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical Activity in people with Stress Disorders, Post-Traumatic, 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 3 inclusion and 7 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 4 Mar 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment (time frame: 2 months). 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 4 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.