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

NCT06993012 | Enrolling By Invitation

• 1 other identifier: STUDY2025-0124
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mobile health; veterans; ptsd; wearable sensor; machine-learning; stress self-management

Outcome Measures

Primary Outcomes (1)

• ML-detected Stress Moments

  Stress Moments is a conceptual real-time measure derived from a combination of physiological heart rate (heartbeats per minute - bpm) measurements and subjective self-reports, both collected through the FWD application on the Apple Watch. Continuous HR data were recorded using either the Apple Watch Series 4 or 5, measuring bpm at a frequency of 1 Hz, enabling high-resolution monitoring for precise identification of physiological stress indicators. Stress events were detected using an integrated algorithm analyzing HR fluctuations, and these were automatically logged in the dataset under a designated "stress detection" column.

  From enrollment through completion of the study, an average of 10 weeks

Secondary Outcomes (3)

• PCL-5 Score

  Weekly through study completion, an average of 10 weeks

• GAD-7 Score

  Weekly through study completion, an average of 10 weeks

• PHQ-8 Score

  Weekly through study completion, an average of 10 weeks

Study Arms (3)

Digital intevention + physical intervention

EXPERIMENTAL

This group will receive full access to FWD and participate in the 1-week intensive cycling intervention.

Behavioral: Mobile Health Stress Self Management System; Behavioral: Intensive Cycling Activity

Physical intervention only

ACTIVE COMPARATOR

This group will have a control version of FWD and participate in the intensive cycling intervention.

Behavioral: Intensive Cycling Activity

No intervention

NO INTERVENTION

This group will have a control version of FWD and not participate in the intensive cycling intervention.

Interventions

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.

Digital intevention + physical intervention; Physical intervention only

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

Digital intevention + physical intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and older
• Self-identifies as Veteran
• Participant has reliable internet access for their phone (Either WIFI or mobile data plan)
• Own an iPhone (IOS 13 or newer)
• score \>10 on the PCL-5 test
• Additionally, participants to be assigned to either intervention group must have registered for a Project Hero Ride 2 Recovery event.

You may not qualify if:

• people unable to consent
• pregnant women where the activities of the research may affect the pregnancy or the fetus
• minors under 18 years of age
• prisoners

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Combat Disorders; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Farzan Sasangohar, Ph.D. Industrial Engineering

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive full access to FWD and participate in the 1-week intensive cycling intervention. One group will have a control version of FWD and participate in the intensive cycling intervention. One group will have a control version of FWD and not participate in the intensive cycling intervention.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 28, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)