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

Trial Summary

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 data supports the effectiveness of the treatment PE Coach App for PTSD?

Prolonged Exposure (PE) therapy is a proven treatment for PTSD, and the PE Coach app is designed to help patients engage more with this therapy. Research shows that PE therapy significantly reduces PTSD symptoms, and the app may enhance this effect by increasing patient involvement. ^{1 2 3 4 5}

How is the PE Coach App treatment for PTSD different from other treatments?

The PE Coach App is unique because it is a mobile application designed to support patients undergoing prolonged exposure therapy for PTSD, potentially increasing patient engagement and supporting recovery by making therapy components more accessible. ^{1 3 4 5 6}

What is the purpose of this trial?

Thousands of mental health mobile applications (apps) are available but limited research has been conducted on their effectiveness. VA has been a leader in mental health mobile app development and must research whether these apps work, and if so, how? PE Coach is a well-designed treatment companion app to one of the most researched, efficacious psychotherapies for PTSD (prolonged exposure), a treatment that has been broadly disseminated throughout VA mental health clinics. Research suggests that VA therapists find the app helpful in supporting patients. Preliminary results suggest that Veteran patients prefer to receive therapy withPE Coach and Veterans complete more recovery-oriented homework when they do. This study will randomize 124 Veterans with PTSD to treatment with or without PE Coach. The project will evaluate the effect of the app on PTSD-related functioning, quality of life, and PTSD symptoms. The investigators will test whether the app improves functioning and symptoms, increases homework, and reduces drop out.

Research Team

Greg M. Reger, PhD

Principal Investigator

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States 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. [2023]

2. England 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. [2022]

3. United States 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. [2022]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for chronic combat-related PTSD: a case report of five veterans. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Review of exposure therapy: a gold standard for PTSD treatment. [2021]