- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04383496
Increasing Activity for Veterans With PTSD (I CARE for Vet)
I CARE for Vets: InCreasing Activity & REcovery for Veterans With PTSD
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Physical Activity
In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
|
In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment
Time Frame: 2 months
|
Proportion enrolled out of total patients identified as eligible
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability
Time Frame: 4 months
|
Interviews on usability of wearable device; barriers and facilitators to attendance
|
4 months
|
Attendance
Time Frame: 1 month
|
Proportion of participants who attend 75% of in-person visits
|
1 month
|
Retention
Time Frame: 4 months
|
Proportion of participants who complete post-intervention assessments at 4 months follow-up
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity
Time Frame: 4 months
|
Activity tracking (wearable device), steps per day
|
4 months
|
Physical functioning
Time Frame: 4 months
|
Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning
|
4 months
|
PTSD symptoms
Time Frame: 4 months
|
PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse)
|
4 months
|
Depressive symptoms
Time Frame: 4 months
|
Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse)
|
4 months
|
pain
Time Frame: 4 months
|
PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference
|
4 months
|
Fatigue
Time Frame: 4 months
|
Patient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue
|
4 months
|
Sleep quality
Time Frame: 4 months
|
Pittsburgh Sleep Quality Index, range 0-21, higher is poorer sleep
|
4 months
|
Gait speed
Time Frame: 4 months
|
usual walking speed over 6 meters (in seconds/meter)
|
4 months
|
Sit to stand
Time Frame: 4 months
|
# of sit-to-stands completed in 30 seconds
|
4 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wei Denise Duan-Porter, MD PhD, Minneapolis VA Health Care System, Minneapolis, MN
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3302-P
- RX003302-01A1 (OTHER_GRANT: VA RR&D)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress Disorders, Post-Traumatic
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
Oregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH); Oregon Clinical...CompletedPost-Traumatic Stress DisordersUnited States
-
US Department of Veterans AffairsEmory UniversityWithdrawnPost-Traumatic Stress Disorders
-
University of KonstanzGerman Research Foundation; NGO vivo e.V.; GTZ-German Technical Cooperation,... and other collaboratorsCompletedPost-Traumatic Stress DisordersSri Lanka
-
University Hospital, ToulouseCompletedPost-traumatic StressFrance
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruitingPost-traumatic Stress DisorderFrance
-
VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesRecruitingPost-Traumatic Stress DisorderUnited States
Clinical Trials on Physical Activity
-
Health Education Research Foundation (HERF)CompletedQuality of LifePakistan
-
Zohra Institute of Health SciencesCompletedPhysical Activity and StressPakistan
-
Centre Hospitalier Universitaire DijonWithdrawn
-
Fundacion para la Investigacion y Formacion en...CompletedImpaired CognitionSpain
-
Cardenal Herrera UniversityRecruiting
-
Istituti Clinici Scientifici Maugeri SpAActive, not recruiting
-
AUSL Romagna RiminiFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRecruitingNon-Small Cell Lung CancerItaly
-
Fundación para la Investigación del Hospital Clínico...CompletedObesity | Severe Mental Disorder
-
Augusta UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Kansas... and other collaboratorsCompletedMental Disorders, SevereUnited States
-
Centre Hospitalier Departemental VendeeTerminated