Increasing Activity for Veterans With PTSD

NCT04383496 | Completed Phase 1 Results

• 2 other identifiers: D3302-PRX003302-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; Exercise; Physical Performance; Mobility Limitation; Wearable Electronic Devices

Outcome Measures

Primary Outcomes (1)

• Recruitment

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

  2 months

Secondary Outcomes (3)

• Total # Participants Completing Acceptability Interviews

  4 months

• Attendance

  1 month

• Retention

  4 months

Other Outcomes (9)

• Physical Activity

  2 months

• Physical Functioning

  4 months

• PTSD Symptoms

  4 months

Study Arms (1)

Physical Activity

EXPERIMENTAL

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

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

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

Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity; Mobility Limitation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Wei Duan-Porter
• Organization: Minneapolis VA Health Care System

wei.duanporter@va.gov

6124675845

Study Officials

• Wei Denise Duan-Porter, MD PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 12, 2020
• Study Start: March 2, 2021
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: March 4, 2025
• Results First Posted: October 10, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)