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Completed

NCT Number: NCT04383496

Increasing Activity 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation

Primary outcomes

  1. Recruitment

    Time frame: 2 months

    total participants enrolled in intervention (out of total patients identified as eligible)

Secondary outcomes

  1. Total # Participants Completing Acceptability Interviews

    Time frame: 4 months

    Number of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance

  2. 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)

  3. Retention

    Time frame: 4 months

    Number of participants who complete post-intervention assessments at 4 months follow-up

Other outcomes

  1. Physical Activity

    Time frame: 2 months

    Activity tracking (wearable device), number of days meeting activity goal (per week) at 8 weeks

  2. Physical Functioning

    Time frame: 4 months

    Physical Component Score of Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning

  3. PTSD Symptoms

    Time frame: 4 months

    PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse)

  4. Depressive Symptoms

    Time frame: 4 months

    Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse)

  5. Pain Intensity and Interference

    Time frame: 4 months

    PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference

  6. 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

  7. Sleep-related Impairment

    Time frame: 4 months

    PROMIS sleep measure, standardized T score (0-100), higher is poorer sleep

  8. 6 Minute Walk

    Time frame: 4 months

    distance walked in 6 min (in meters)

  9. Sit to Stand

    Time frame: 4 months

    # of sit-to-stands completed in 30 seconds

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

I CARE for Vets: InCreasing Activity & REcovery for Veterans With PTSD

Acronym: I CARE for Vet

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 12, 2020
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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