Stress Disorders, Post-Traumatic
Conditions
Keywords
PTSD, Exercise, Physical Performance, Mobility Limitation, Wearable Electronic Devices
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.
Interventions
In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Sponsors
Study design
Intervention 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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 2 months | total participants enrolled in intervention (out of total patients identified as eligible) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total # Participants Completing Acceptability Interviews | 4 months | Number of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance |
| Attendance | 1 month | Number of participants who attended 75% of session visits (3 out of 4 group sessions; 5 of 7 individual follow-up calls) |
| Retention | 4 months | Number of participants who complete post-intervention assessments at 4 months follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity and Interference | 4 months | PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference |
| Fatigue | 4 months | Patient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue |
| Physical Activity | 2 months | Activity tracking (wearable device), number of days meeting activity goal (per week) at 8 weeks |
| 6 Minute Walk | 4 months | distance walked in 6 min (in meters) |
| Sit to Stand | 4 months | \# of sit-to-stands completed in 30 seconds |
| Sleep-related Impairment | 4 months | PROMIS sleep measure, standardized T score (0-100), higher is poorer sleep |
| Physical Functioning | 4 months | Physical Component Score of Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning |
| PTSD Symptoms | 4 months | PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse) |
| Depressive Symptoms | 4 months | Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse) |
Countries
United States
Participant flow
Recruitment details
Goal recruitment was 6-8 participants for each of 3 pilot groups (max 24 total). The actual number of participants enrolled reflects those who completed informed consent and attended the baseline assessment and education session with the physical therapist (6, 8, and 7 for 3 groups). Because this was a group intervention, if participants failed to attend the informed consent or baseline visit (including attempts at rescheduling), we were unable to recruit additional participants for that group.
Pre-assignment details
24 participants completed informed consent and were enrolled but only 21 completed the baseline visits (required before moving onto the intervention)
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Physical Activity |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 53.9 years STANDARD_DEVIATION 12.6 |
| Race/Ethnicity, Customized Race/Ethnicity Asian or Native Hawaiian | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latino | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 13 Participants |
| Region of Enrollment United States | 21 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 1 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Recruitment
total participants enrolled in intervention (out of total patients identified as eligible)
Time frame: 2 months
Population: Data represents the total number of participants who completed informed consent
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physical Activity | Recruitment | 24 Participants |
Attendance
Number of participants who attended 75% of session visits (3 out of 4 group sessions; 5 of 7 individual follow-up calls)
Time frame: 1 month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Physical Activity | Attendance | Attendance at Group Sessions | 19 Participants |
| Physical Activity | Attendance | Attendance at Individual Follow-up | 20 Participants |
Retention
Number of participants who complete post-intervention assessments at 4 months follow-up
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physical Activity | Retention | 17 Participants |
Total # Participants Completing Acceptability Interviews
Number of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance
Time frame: 4 months
Population: Participants who enrolled in study and were invited to interviews
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physical Activity | Total # Participants Completing Acceptability Interviews | 19 Participants |
6 Minute Walk
distance walked in 6 min (in meters)
Time frame: 4 months
Population: complete follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | 6 Minute Walk | 539 meters | Standard Deviation 114 |
Depressive Symptoms
Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse)
Time frame: 4 months
Population: complete follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Depressive Symptoms | 7.63 units on a scale | Standard Deviation 5.54 |
Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue
Time frame: 4 months
Population: participants with complete follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Fatigue | 55.8 score on a scale | Standard Deviation 11.2 |
Pain Intensity and Interference
PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference
Time frame: 4 months
Population: complete follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Pain Intensity and Interference | 5.1 units on a scale | Standard Deviation 2.1 |
Physical Activity
Activity tracking (wearable device), number of days meeting activity goal (per week) at 8 weeks
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Physical Activity | 3.41 days meeting activity goal/week | Standard Deviation 1.85 |
Physical Functioning
Physical Component Score of Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning
Time frame: 4 months
Population: Participants who completed 4 months follow-up surveys
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Physical Functioning | 30.9 units on a scale | Standard Deviation 5.7 |
PTSD Symptoms
PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse)
Time frame: 4 months
Population: Complete baseline and follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | PTSD Symptoms | 49.6 units on a scale | Standard Deviation 16.1 |
Sit to Stand
\# of sit-to-stands completed in 30 seconds
Time frame: 4 months
Population: complete follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Sit to Stand | 19.1 sit-to-stand events | Standard Deviation 9.6 |
Sleep-related Impairment
PROMIS sleep measure, standardized T score (0-100), higher is poorer sleep
Time frame: 4 months
Population: complete follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Sleep-related Impairment | 56.7 score on a scale | Standard Deviation 11.2 |