An Integrative, Digital Health Approach to Veteran-Centered PTSD Care (NCT06993012) | Clinical Trial Compass
By InvitationNot Applicable
An Integrative, Digital Health Approach to Veteran-Centered PTSD Care
United States36 participantsStarted 2025-04-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ML-detected Stress Moments
Timeframe: From enrollment through completion of the study, an average of 10 weeks