An Integrative, Digital Health Approach to Veteran-Centered PTSD Care

Part of paid clinical trials in College Station, Texas.

Sponsor
Texas A&M University
Study ID
NCT06993012
Status
Enrolling By Invitation

Conditions

  • Depression/Anxiety
  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Mobile Health Stress Self Management System — BEHAVIORAL
    FWD has been developed using proprietary machine-learning algorithms to detect physiological markers of stress/PTSD hyperarousal in veterans using a wearable smart watch sensor. Additionally, FWD includes a suite of self-management and monitoring tools through the smartphone app designed through several rounds of human factors design
  • Intensive Cycling Activity — BEHAVIORAL
    The Project Hero Ride 2 Recovery is a unique event hosted by Project Hero where veterans participate in a week long cycling challenge where they cycle across the continental US about 50-70 miles per day for a total of over 350 miles within a group of peers.

Study Details

The goal of this study is to test the effectiveness of a stress self-management mobile health system (smartphone app + wearable sensor) alongside an intense physical cycling intervention to reduce symptoms of stress in a veteran population. The main questions this study aims to answer are: Does a mobile stress self-management system alongside intensive physical activity reduce the amount of physiologically detected, via machine-learning algorithm, stressful moments or PTSD hyperarousals? Can a mobile stress self-management system alongside intensive physical activity reduce symptoms of stress, anxiety, and depression on self-assessments like PCL-5, GAD-7, and PHQ-8? Participants will: Use a stress self-management system called First Watch Device (FWD) and confirm/deny detected stress moments on the app for a 2 month period. Use FWD self-management features as coping stragies for mental health and stressors for a 2 month period. Participate in the Project Hero 1-week Ride 2 Recovery Challenge events in the middle of the study.

Key Dates

Start date
Apr 21, 2025
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital intevention + physical intervention
    This group will receive full access to FWD and participate in the 1-week intensive cycling intervention.
  • Active Comparator: Physical intervention only
    This group will have a control version of FWD and participate in the intensive cycling intervention.
  • No Intervention: No intervention
    This group will have a control version of FWD and not participate in the intensive cycling intervention.

Primary Outcome Measure

ML-detected Stress Moments [ Time Frame: From enrollment through completion of the study, an average of 10 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Texas A&M UniversityCollege StationTexas77843-

Find similar trials in College Station, TX

By research site
Texas A&M University· College Station, TX

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