Cycling + Mobile Health System for Post-Traumatic Stress Disorder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Disqualifiers: Pregnancy, Minors, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Farzan Sasangohar, Ph.D. Industrial Engineering

Principal Investigator

Texas A&M University

Eligibility Criteria

This trial is for veterans experiencing PTSD, stress, anxiety, or depression. Participants will use a mobile health system and engage in intensive cycling for two months. They must be willing to confirm stress moments via an app and partake in a week-long cycling event.

Inclusion Criteria

I own an iPhone with IOS 13 or newer.

Participant has reliable internet access for their phone (Either WIFI or mobile data plan)

Additionally, participants to be assigned to either intervention group must have registered for a Project Hero Ride 2 Recovery event.

Exclusion Criteria

Prisoners

I am under 18 years old.

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants undergo baseline assessments and prepare for the intervention

4 weeks

1 visit (in-person), weekly virtual check-ins

Intervention

Participants engage in a 1-week intensive cycling event and use the FWD app for stress management

1 week

Daily in-person cycling sessions

Post-intervention

Participants continue using the FWD app and complete follow-up assessments

4 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Intensive Cycling Activity
• Mobile Health Stress Self Management System

Trial Overview The study tests if combining a mobile health stress self-management system (app + sensor) with intense physical activity can reduce physiologically detected stressful moments and improve mental health symptoms as measured by standard assessments.

Participant Groups

Group I: Digital intevention + physical intervention Experimental Treatment 2 Interventions

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

Group II: Physical intervention only Active Control 1 Intervention

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

Group III: No intervention Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+