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Increasing Activity for Veterans With PTSD (I CARE for Vet)

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Exercise, Physical Performance, Mobility Limitation, Wearable Electronic Devices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minneapolis VA Health Care System, Minneapolis, MN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity

Arm Description

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

Outcomes

Primary Outcome Measures

Recruitment
Proportion enrolled out of total patients identified as eligible

Secondary Outcome Measures

Acceptability
Interviews on usability of wearable device; barriers and facilitators to attendance
Attendance
Proportion of participants who attend 75% of in-person visits
Retention
Proportion of participants who complete post-intervention assessments at 4 months follow-up

Full Information

First Posted
April 29, 2020
Last Updated
July 13, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04383496
Brief Title
Increasing Activity for Veterans With PTSD
Acronym
I CARE for Vet
Official Title
I CARE for Vets: InCreasing Activity & REcovery for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, Exercise, Physical Performance, Mobility Limitation, Wearable Electronic Devices

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity
Arm Type
Experimental
Arm Description
In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Primary Outcome Measure Information:
Title
Recruitment
Description
Proportion enrolled out of total patients identified as eligible
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Acceptability
Description
Interviews on usability of wearable device; barriers and facilitators to attendance
Time Frame
4 months
Title
Attendance
Description
Proportion of participants who attend 75% of in-person visits
Time Frame
1 month
Title
Retention
Description
Proportion of participants who complete post-intervention assessments at 4 months follow-up
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Physical Activity
Description
Activity tracking (wearable device), steps per day
Time Frame
4 months
Title
Physical functioning
Description
Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning
Time Frame
4 months
Title
PTSD symptoms
Description
PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse)
Time Frame
4 months
Title
Depressive symptoms
Description
Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse)
Time Frame
4 months
Title
pain
Description
PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference
Time Frame
4 months
Title
Fatigue
Description
Patient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue
Time Frame
4 months
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index, range 0-21, higher is poorer sleep
Time Frame
4 months
Title
Gait speed
Description
usual walking speed over 6 meters (in seconds/meter)
Time Frame
4 months
Title
Sit to stand
Description
# of sit-to-stands completed in 30 seconds
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Denise Duan-Porter, MD PhD
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Increasing Activity for Veterans With PTSD

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