Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417, United States
NCT Number: NCT04383496
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Minneapolis, Minnesota, 55417, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Time frame: 2 months
total participants enrolled in intervention (out of total patients identified as eligible)
Time frame: 4 months
Number of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance
Time frame: 1 month
Number of participants who attended 75% of session visits (3 out of 4 group sessions; 5 of 7 individual follow-up calls)
Time frame: 4 months
Number of participants who complete post-intervention assessments at 4 months follow-up
Time frame: 2 months
Activity tracking (wearable device), number of days meeting activity goal (per week) at 8 weeks
Time frame: 4 months
Physical Component Score of Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning
Time frame: 4 months
PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse)
Time frame: 4 months
Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse)
Time frame: 4 months
PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference
Time frame: 4 months
Patient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue
Time frame: 4 months
PROMIS sleep measure, standardized T score (0-100), higher is poorer sleep
Time frame: 4 months
distance walked in 6 min (in meters)
Time frame: 4 months
# of sit-to-stands completed in 30 seconds
VA Office of Research and Development
Fed
I CARE for Vets: InCreasing Activity & REcovery for Veterans With PTSD
Acronym: I CARE for Vet
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