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

NCT06993012 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-02

No results posted yet for this study

Summary

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.

Conditions

  • PTSD - Post Traumatic Stress Disorder
  • Depression/Anxiety

Interventions

BEHAVIORAL

Mobile Health Stress Self Management System

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

BEHAVIORAL

Intensive Cycling Activity

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.

Sponsors & Collaborators

Principal Investigators

  • Farzan Sasangohar, Ph.D. Industrial Engineering · Texas A&M University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-21
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06993012 on ClinicalTrials.gov