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Increasing Activity for Veterans With PTSD

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04383496
Acronym
I CARE for Vet
Enrollment
24
Registered
2020-05-12
Start date
2021-03-02
Completion date
2022-06-28
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

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

BEHAVIORALPhysical Activity

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Recruitment2 monthstotal participants enrolled in intervention (out of total patients identified as eligible)

Secondary

MeasureTime frameDescription
Total # Participants Completing Acceptability Interviews4 monthsNumber of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance
Attendance1 monthNumber of participants who attended 75% of session visits (3 out of 4 group sessions; 5 of 7 individual follow-up calls)
Retention4 monthsNumber of participants who complete post-intervention assessments at 4 months follow-up

Other

MeasureTime frameDescription
Pain Intensity and Interference4 monthsPEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference
Fatigue4 monthsPatient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue
Physical Activity2 monthsActivity tracking (wearable device), number of days meeting activity goal (per week) at 8 weeks
6 Minute Walk4 monthsdistance walked in 6 min (in meters)
Sit to Stand4 months\# of sit-to-stands completed in 30 seconds
Sleep-related Impairment4 monthsPROMIS sleep measure, standardized T score (0-100), higher is poorer sleep
Physical Functioning4 monthsPhysical Component Score of Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning
PTSD Symptoms4 monthsPTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse)
Depressive Symptoms4 monthsPatient 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

ArmCount
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
Total21

Baseline characteristics

CharacteristicPhysical Activity
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
5 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
Age, Continuous53.9 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 typeEG000
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

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Physical ActivityRecruitment24 Participants
Secondary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Physical ActivityAttendanceAttendance at Group Sessions19 Participants
Physical ActivityAttendanceAttendance at Individual Follow-up20 Participants
Secondary

Retention

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

Time frame: 4 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Physical ActivityRetention17 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Physical ActivityTotal # Participants Completing Acceptability Interviews19 Participants
Other Pre-specified

6 Minute Walk

distance walked in 6 min (in meters)

Time frame: 4 months

Population: complete follow-up data

ArmMeasureValue (MEAN)Dispersion
Physical Activity6 Minute Walk539 metersStandard Deviation 114
Other Pre-specified

Depressive Symptoms

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

Time frame: 4 months

Population: complete follow-up data

ArmMeasureValue (MEAN)Dispersion
Physical ActivityDepressive Symptoms7.63 units on a scaleStandard Deviation 5.54
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Physical ActivityFatigue55.8 score on a scaleStandard Deviation 11.2
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Physical ActivityPain Intensity and Interference5.1 units on a scaleStandard Deviation 2.1
Other Pre-specified

Physical Activity

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

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Physical ActivityPhysical Activity3.41 days meeting activity goal/weekStandard Deviation 1.85
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Physical ActivityPhysical Functioning30.9 units on a scaleStandard Deviation 5.7
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Physical ActivityPTSD Symptoms49.6 units on a scaleStandard Deviation 16.1
Other Pre-specified

Sit to Stand

\# of sit-to-stands completed in 30 seconds

Time frame: 4 months

Population: complete follow-up data

ArmMeasureValue (MEAN)Dispersion
Physical ActivitySit to Stand19.1 sit-to-stand eventsStandard Deviation 9.6
Other Pre-specified

Sleep-related Impairment

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

Time frame: 4 months

Population: complete follow-up data

ArmMeasureValue (MEAN)Dispersion
Physical ActivitySleep-related Impairment56.7 score on a scaleStandard Deviation 11.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026