Mobile App Support for Post-Traumatic Stress Disorder

(PTSDCoach911 Trial)

Overseen By Roberto Lucchini, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Suicidal ideation, Severe alcohol use, Illicit drugs, Neurologic conditions, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist World Trade Center General Responders dealing with PTSD and related issues such as depression and anxiety. It will evaluate two versions of a mobile app called PTSD Coach: one with clinician support (Clinician Supported PTSD Coach) and one without (Self Managed PTSD Coach), to determine which is more effective at reducing symptoms. Participants must live in Florida, have a smartphone, and speak English or Spanish. The goal is to enhance mental health support for this group, particularly those who are Latinx and may have relocated. As an unphased trial, this study offers participants the chance to contribute to innovative mental health solutions that could benefit many in similar situations.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently receiving mental health treatment for PTSD, you may not be eligible to participate.

What prior data suggests that this mobile app intervention is safe for WTC General Responders?

Research has shown that the Clinician-Supported PTSD Coach app holds promise in reducing PTSD symptoms. Studies have found that users, particularly those with clinician support, experience significant improvements in managing PTSD and depression symptoms. Users report high satisfaction with the treatment, indicating it is well-tolerated.

For the Self-Managed PTSD Coach app, findings indicate that participants generally feel satisfied and find the app helpful for their PTSD symptoms. Some studies suggest it may not be more effective than no treatment, yet users still report improvements and appreciate having access to the app.

Overall, both versions of the PTSD Coach app are considered safe and accepted by users, with many reporting positive experiences and relief from symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PTSD Coach mobile app because it provides a unique, accessible way to support individuals with PTSD. Unlike traditional therapies that often require in-person sessions and can be costly, this app allows users to manage their symptoms remotely. The Clinician Supported version of the app combines digital self-help with professional guidance, offering tailored strategies for symptom monitoring and management. Meanwhile, the Self Managed version empowers users to independently navigate their treatment, offering flexibility and privacy. This trial could pave the way for more inclusive and affordable mental health care options.

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

Research has shown that the Clinician Supported PTSD Coach app, a treatment option in this trial, helps reduce PTSD symptoms. Studies found that people using this app with clinician support experience more symptom relief than those receiving standard care. Another treatment option in this trial, the Self-Managed PTSD Coach app, also shows promise, with users reporting satisfaction and moderate to significant symptom relief. Both app versions are designed to help manage stress and improve mental health, making them valuable tools for people dealing with PTSD. ^{1 3 6 7 8}

Who Is on the Research Team?

Mark Macgowan, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

This trial is for World Trade Center General Responders now living in Florida, who have smartphones and are fluent in English or Spanish. It's not for those with recent suicidal thoughts, low distress levels, severe alcohol use, recent illicit drug use (except cannabis), or significant cognitive impairment.

Inclusion Criteria

World Trade Center General Responders (GRs) currently living in Florida

My age does not limit my participation.

Must have a smartphone device capable of using the PTSD Coach app

Exclusion Criteria

Active or recent (past month) suicidal ideation or attempt

Low levels of distress as measured by the PCL-5 (score below 30)

Severe alcohol use measured by an AUDIT score of 20 or above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Clinician-Supported PTSD Coach or Self-Managed PTSD Coach over 8 weeks

8 weeks

4 remotely-delivered sessions for Clinician-Supported group

Follow-up

Participants are monitored for changes in PTSD, depression, anxiety, and sleep disturbances

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinician Supported PTSD Coach
• Self Managed PTSD Coach

Trial Overview The study tests a mobile app called PTSD Coach to manage PTSD symptoms. Participants will either use the app on their own (Self-Managed) or with clinician support over eight weeks. A third group waits without treatment initially. The effectiveness of reducing mental health symptoms is measured after 8 and 12 weeks.

How Is the Trial Designed?

Group I: Clinician Supported PTSD Coach Experimental Treatment 1 Intervention

PTSD Coach application combined with remotely delivered clinician support, focusing on app use, symptom monitoring, and management strategies.

Group II: Self Managed PTSD Coach application Active Control 1 Intervention

Participant remotely receives basic instructions on using the PTSD Coach application but receives no further clinician support

Group III: Wait list control Active Control 1 Intervention

No intervention until after the follow-up assessment when they have a choice of receiving either CS PTSD Coach or SM PTSD Coach.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

National Institute for Occupational Safety and Health (NIOSH/CDC)

Collaborator

Trials

44

Recruited

50,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

Clinicians rated the PTSD Coach Australia app as having an 'average' to 'good' quality, viewing it as a useful tool for tracking symptoms and enhancing engagement between therapy sessions.

Despite its potential benefits, clinicians raised concerns about the app's user-friendliness and technical issues, such as freezing on Android devices, highlighting the need for improvements to ensure better usability for Defence members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicians' perceptions of PTSD Coach Australia. Strodl, E., Shakespeare-Finch, J., Alichniewicz, KK., et al.[2022]

The pilot study involving 49 trauma survivors indicated that the PTSD Coach app is feasible and acceptable, with participants using it frequently and reporting it as moderately helpful for managing their symptoms.

While the app showed modest effect sizes for PTSD symptom improvement, the results were not statistically significant, suggesting that more research is needed to fully evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and potential efficacy of the PTSD Coach app: A pilot randomized controlled trial with community trauma survivors. Miner, A., Kuhn, E., Hoffman, JE., et al.[2022]

A smartphone-based intervention program for military service members with subthreshold PTSD symptoms showed significant reductions in PTSD Checklist scores from baseline to post-intervention, with effects maintained at a 3-month follow-up.

The program, which included a Skype session and daily text messages guiding app use, was found to be feasible and acceptable to participants, indicating potential for broader application in addressing PTSD symptoms in military populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GETSmart: Guided Education and Training via Smart Phones to Promote Resilience. Roy, MJ., Highland, KB., Costanzo, MA.[2022]

The 'PTSD Coach' intervention, available as both a web-based and mobile application, is feasible and generally well-accepted among trauma-exposed individuals, with high satisfaction reported in most studies.

However, the effectiveness of the 'PTSD Coach' in significantly reducing posttraumatic stress symptoms (PTSS) remains unclear, as the pooled effect size was not statistically significant, indicating a need for further research, especially in low-middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and effectiveness of web-based and mobile PTSD Coach: a systematic review and meta-analysis. Bröcker, E., Suliman, S., Olff, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10022983/

A Randomized Clinical Trial of Clinician-Supported PTSD ... CS PTSD Coach participants improved more on patient-reported PTSD severity at post-treatment than TAU participants (D = . 28, p = .

2. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id44682.pdf

Using PTSD Coach in primary care with and without clinician ... Clinician-Supported PTSD Coach resulted in more specialty PTSD care use postintervention and possibly greater reductions in PTSD symptoms. Conclusions: Both ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02685358

An RCT of a Primary Care-Based PTSD Intervention ... This randomized clinical trial will enroll and treat 260 VA primary care patients (female and male) who have PTSD and are not currently being treated for it.

4. tandfonline.com tandfonline.com/doi/full/10.1080/20008066.2023.2209469

Feasibility, acceptability, and effectiveness of web-based ... Findings support the feasibility and acceptability of 'PTSD Coach' in trauma-exposed individuals. However, evidence on the effectiveness on PTSS remains ...

5. reporter.nih.gov reporter.nih.gov/project-details/9079205

Clinician-Supported PTSD Coach - NIH RePORTER This proposal will contribute to improving the mental health of primary care patients with PTSD by teaching coping skills to manage PTSD symptoms and increasing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10808979/

A counsellor-supported 'PTSD Coach' intervention versus ... We hypothesised that PTSD Coach-CS is superior to e-TAU in reducing clinician-monitored PTSD symptoms (primary outcome) as well as self-reported PTSD, ...

7. mental.jmir.org mental.jmir.org/2022/3/e34744/PDF

PTSD Coach Version 3.1 This study focuses on assessing the public health impact of an. mHealth app for posttraumatic stress disorder (PTSD), with substantial updates ...

8. mhealth.amegroups.org mhealth.amegroups.org/article/view/19622/html

PTSD Coach around the world - Kuhn - mHealth Emerging research on PTSD Coach demonstrates high user satisfaction, feasibility, and improvement in PTSD symptoms and other psychosocial ...