Increasing Activity for Veterans With PTSD

Stress Disorders, Post-Traumatic Clinical Trial

— I CARE for Vet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383496
• Other study ID #: D3302-P
• Secondary ID: RX003302-01A1
• Status: Completed
• Phase: Phase 1
• Start date: March 2, 2021
• Est. completion date: June 28, 2022

Study information

• Verified date: July 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Physical Activity
In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

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