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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a smartphone app and wearable sensor, known as the Mobile Health Stress Self Management System, can help veterans manage stress alongside intense cycling activities. The goal is to determine if this combination can reduce stress and symptoms of anxiety and depression. Participants will use the app to track and manage stress while participating in a week-long cycling challenge. Veterans with PTSD symptoms who have iPhones and internet access might be suitable candidates, especially if they are enrolled in the Project Hero Ride. As an unphased trial, this study offers veterans the chance to explore innovative stress management tools and contribute to research that could benefit others.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile health system and cycling intervention are safe for veterans with PTSD?

Research has shown that mobile health apps can help manage symptoms of PTSD (post-traumatic stress disorder) and depression. One study found that using a self-management app reduced these symptoms and was well-received by users. Users have not reported major side effects, making these apps a promising option for symptom management.

Exercise, particularly cycling, is known to improve symptoms of anxiety and PTSD. Studies indicate that physical activity benefits both the mind and body. Specifically, exercise has reduced PTSD symptoms and enhanced overall emotional well-being. While exercise is generally safe, individuals should be mindful of personal limits.

Overall, both mobile health apps and regular cycling are considered safe for most people. However, discussing any concerns with a healthcare provider is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines cycling with a Mobile Health Stress Self Management System to help people with PTSD. Unlike traditional treatments like therapy or medication, this approach uses a digital platform to support mental health, allowing users to access help anytime, anywhere. The cycling component adds a physical activity element, which is known to have mental health benefits. This innovative combination could offer a more holistic, accessible, and flexible way to manage PTSD symptoms.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that smartphone apps can help reduce symptoms of PTSD and depression. One study found that a self-help app effectively lowered these symptoms for users. Another study demonstrated that using a PTSD Coach app for three months led to noticeable improvements in stress and depression. However, not all studies agree, with some showing only small improvements. In this trial, one group will receive a Mobile Health Stress Self Management System alongside an intensive cycling intervention, while another group will participate in the cycling intervention only. Physical activities like intense cycling generally reduce stress and improve mental health. Combining these methods might offer a promising way to manage stress and PTSD symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Farzan Sasangohar, Ph.D. Industrial Engineering

Principal Investigator

Texas A&M University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5680516/

Posttraumatic Stress Disorder and Mobile Health: App ... Patients can use apps to monitor and manage their symptoms, record and replay therapy sessions, connect with clinicians or emergency personnel in the case of ...

2. jmir.org jmir.org/2025/1/e69426

Cost-Effectiveness of App-Guided Self-Management for ... Objective: This study aimed to assess the cost-effectiveness of an app-based intervention for self-management of posttraumatic stress compared ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2020.00003/full

Efficacy of Self-Management Smartphone-Based Apps for ... Overall, despite positive pre-post effects, current results indicate that smartphone-apps for PTSD patients are not significantly more effective ...

4. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id47101.pdf

A randomized controlled trial of a smartphone app for ... This randomized controlled trial suggests that a self-management mobile app may be an efficacious intervention that can reduce PTSD and depression symptom ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2214782923000180

Longitudinal follow-up of the randomized controlled trial ... We found that the Swedish version of the self-management app PTSD Coach confers benefits on posttraumatic stress and depressive symptoms after three months use.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5438780/

Post-traumatic Stress Disorder and 20-Year Physical ... Individuals with PTSD may limit exercise owing to a heightened concern for safety ... In this subsample, PA data before and after trauma exposure or PTSD symptom ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/4294753

Physical Activity and Exercise as a Tool to Cure Anxiety ... Exercise has been shown to positively affect the signs and symptoms of generalized anxiety disorder (GAD), posttraumatic stress disorder (PTSD), ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11125787/

Enjoyment and Affective Responses to Moderate and High- ... This study is among the first to assess acute changes in affective states relative to various exercise modes in individuals living with subsyndromal PTSD.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06127342

Exercise and Emotional Learning in Posttraumatic Stress ... The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a ...

10. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1483077/full

A narrative review of exercise intervention mechanisms for ... Exercise was found to reduce PTSD symptoms in veterans at both psychological and physiological levels, which in turn inhibits their suicidal tendencies.