PE Coach App for PTSD

Overseen By Greg M Reger, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Psychotropics

Disqualifiers: Neurological conditions, Psychosis, Suicide, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8-15 weeks

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app called PE Coach can help Veterans with PTSD (post-traumatic stress disorder) improve their treatment outcomes. The study will compare two groups: one using the app alongside therapy and one without the app. Researchers seek to understand if the app can enhance PTSD-related functioning, quality of life, and therapy participation. Veterans diagnosed with PTSD, receiving therapy through the VA, and comfortable using a mobile device may be a good fit for this trial. As an unphased study, this trial offers Veterans the opportunity to contribute to innovative research that could improve PTSD treatment for themselves and others.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their psychotropic medications (medications affecting the mind, emotions, and behavior) for at least 6 weeks before joining. This means you should not change your current medications during this period before starting the trial.

What prior data suggests that the PE Coach app is safe for use in PTSD treatment?

Research has shown that both therapists and patients appreciate the PE Coach app. Therapists find it useful for assisting patients with prolonged exposure therapy for PTSD (Post-Traumatic Stress Disorder). Early results suggest that veterans using the app are more likely to complete their therapy homework, indicating strong involvement in treatment.

No known safety issues exist with using the PE Coach app. As a tool to aid therapy, not a treatment or medication itself, it is generally safe for use during therapy sessions. Studies have not reported any specific negative effects, making it a low-risk option for those considering it for PTSD therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PE Coach app for PTSD because it integrates technology into traditional therapy, making treatment more accessible and engaging. Unlike standard prolonged exposure therapy, which relies solely on in-person sessions, PE Coach supports patients with a mobile app that guides them through therapy and homework. This app could enhance adherence to therapy and make it easier for patients to practice techniques between sessions, potentially leading to better outcomes. By using technology to support mental health treatment, PE Coach offers a modern approach that could increase the effectiveness of proven therapies.

What evidence suggests that the PE Coach app is effective for PTSD?

Research has shown that the PE Coach app, available to participants in this trial, can enhance the effectiveness of prolonged exposure therapy for PTSD. In earlier studies, patients using the app completed more therapy homework, which is crucial for improvement. The app assists patients in organizing and managing their therapy tasks. Early results indicate that patients using the app experience better functioning and fewer PTSD symptoms. Therapists also find the app useful for supporting patients during treatment. Overall, the app appears promising in helping Veterans with PTSD gain more from prolonged exposure therapy. Meanwhile, another group in this trial will receive standard prolonged exposure therapy without the app, serving as an active comparator. ^{3 4 5 6 7}

Who Is on the Research Team?

Greg M. Reger, PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18-65 with PTSD, fluent in English, willing to use the PE Coach mobile app alongside therapy. They must be enrolled in VA healthcare and have a PTSD diagnosis with a severity score of at least 26. Exclusions include severe neurological conditions or TBI, ongoing threatening situations, other current recommended PTSD therapies, inability to use mobile devices properly due to physical conditions, severe alcohol use disorder, multiple prior PE therapy sessions for PTSD, psychotic symptoms-related mental health conditions or instability on psychotropic medications.

Inclusion Criteria

I have been diagnosed with PTSD with a severity score of 26 or higher.

enrolled in VA healthcare and eligible for VA PTSD psychotherapy

I am willing to attend therapy sessions in person or via video call and use a mobile device for it.

Exclusion Criteria

You are currently in a dangerous situation, such as experiencing domestic violence.

I am currently receiving recommended psychotherapy for PTSD.

I haven't been stable on my mental health medications for 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8-15 weekly individual PE psychotherapy sessions with or without the PE Coach app

8-15 weeks

8-15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PE Coach
• Prolonged exposure without PE Coach

Trial Overview The study tests the effectiveness of the 'PE Coach' app as an adjunct to prolonged exposure psychotherapy for treating PTSD among Veterans. It compares outcomes between those using the app and those undergoing standard therapy without it. The focus is on whether the app improves functioning and symptoms of PTSD while increasing engagement with recovery-oriented homework and reducing dropout rates from treatment.

How Is the Trial Designed?

Group I: Prolonged exposure with PE Coach Experimental Treatment 1 Intervention

The mobile application will be incorporated into each PE psychotherapy session and used to support homework between sessions.

Group II: Prolonged exposure without PE Coach Active Control 1 Intervention

Standard PE treatment protocol without PE Coach

PE Coach is already approved in United States for the following indications:

Approved in United States as PE Coach for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury

Collaborator

Trials

3

Recruited

320+

Published Research Related to This Trial

A training workshop on prolonged exposure (PE) therapy for PTSD significantly improved the self-efficacy and outcome expectations of 45 psychologists, leading to increased use of PE techniques in their practice.

The study highlights the importance of combining training with intensive consultation to enhance the delivery of evidence-based PTSD treatments, suggesting that such approaches could help more emergency service patients receive effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. Wade, D., Terhaag, S., Putica, A., et al.[2021]

Prolonged exposure (PE) therapy is an effective first-line treatment for PTSD in Veterans and military personnel, significantly reducing symptoms and comorbid issues like anger and depression, supported by extensive research and clinical guidelines.

The PE protocol includes key components such as psychoeducation and exposure techniques, and the Veterans Health Administration has trained over 1,300 mental health providers to deliver this therapy, indicating a strong commitment to improving PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of exposure therapy: a gold standard for PTSD treatment. Rauch, SA., Eftekhari, A., Ruzek, JI.[2021]

A randomized clinical trial involving 124 veterans with PTSD will assess the effectiveness of the PE Coach app in enhancing the outcomes of prolonged exposure therapy, focusing on improvements in social and occupational functioning, quality of life, and reductions in PTSD symptoms.

The study aims to determine if the PE Coach app increases treatment adherence and reduces dropout rates, potentially leading to better overall engagement with the therapy and improved mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and methods of a randomized controlled trial evaluating the effects of the PE Coach mobile application on prolonged exposure among veterans with PTSD. Reger, GM., Smolenski, D., Williams, R., et al.[2023]

Providers who received post-workshop consultation after a 4-day prolonged exposure therapy (PE) training reported significantly higher self-efficacy and used more components of PE, leading to better treatment delivery.

Patients treated by providers with post-workshop consultation experienced faster reductions in PTSD symptoms and lower severity at follow-up assessments, indicating that ongoing support for providers can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Foa, EB., McLean, CP., Brown, LA., et al.[2022]

A study involving 160 active-duty military personnel with PTSD found that 60-minute prolonged exposure (PE) therapy sessions are just as effective as the standard 90-minute sessions, making treatment more accessible in settings that typically use shorter appointment times.

Both the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5) showed that the efficacy of 60-minute sessions was noninferior to 90-minute sessions, suggesting that shorter sessions can be effectively implemented without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. Foa, EB., Bredemeier, K., Acierno, R., et al.[2022]

Prolonged exposure (PE) therapy significantly reduced PTSD symptoms in five patients with severe chronic combat-related PTSD, showing a mean decrease of 48% in PTSD Symptom Scale scores after 10-15 sessions.

Four out of five patients maintained or continued to improve their symptoms 6-18 months post-treatment, indicating the long-term efficacy of PE therapy for combat-related PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for chronic combat-related PTSD: a case report of five veterans. Nacasch, N., Foa, EB., Fostick, L., et al.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423000381

Design and methods of a randomized controlled trial ... This study evaluating the PTSD-related functioning and mental health symptom improvements of PE with and without PE Coach is of clear VA and public health ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04959695

Study Details | NCT04959695 | Evaluation of the PE Coach ... PE Coach may provide the cognitive and organizational support that Veterans with PTSD need to successfully complete treatment and maximize outcomes. However, ...

3. ptsd.va.gov ptsd.va.gov/PTSD/professional/articles/article-pdf/id41830.pdf

The "PE Coach" Smartphone Application The data generated and stored on that device during use of PE Coach is sensitive and includes audio recordings of psychotherapy sessions, multiple self-reports ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36758935/

Design and methods of a randomized controlled trial ... We also hypothesize that including PE Coach will reduce assessor-masked PTSD symptom severity, relative to PE without the app, as assessed by ...

5. psycnet.apa.org psycnet.apa.org/record/2024-48475-001

Pilot randomized, crossover trial of prolonged exposure with ... Prolonged exposure (PE) Coach is a mobile application designed to support the tasks of PE psychotherapy for posttraumatic stress disorder (PTSD).

6. ptsd.va.gov ptsd.va.gov/appvid/mobile/pecoach_app_public.asp

Mobile App: PE Coach - PTSD: National Center for PTSD PE Coach is a free mobile app that helps you work with your therapist during Prolonged Exposure therapy. The app helps you keep track of homework and PTSD ...

7. play.google.com play.google.com/store/apps/details?id=gov.va.mobilehealth.ncptsd.pecoach&hl=en_US

PE Coach 2 - Apps on Google Play The app will guide you through the exercises assigned by your therapist and allows you to track and record your progress.