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PE Coach App for PTSD
N/A
Recruiting
Led By Greg M. Reger, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
current diagnosis of PTSD based on CAPS-5, Minimum total severity score of 26 or higher
Veterans aged 18-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx week 8 (mid-treatment), approx. week 16 (post-treatment), approx week 20 (1-month f/up), approx week 32 (4-month f/up)
Awards & highlights
Study Summary
This trial will test whether the PE Coach app improves symptoms of PTSD, quality of life, and PTSD-related functioning in veterans.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a psychological intervention through an app rather than medication or medical procedures, traditional side effects are not applicable. However, participants may experience discomfort or emotional distress related to engaging more intensively with their therapeutic process due to increased homework completion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD with a severity score of 26 or higher.
Select...
I am a veteran between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approx week 8 (mid-treatment), approx. week 16 (post-treatment), approx week 20 (1-month f/up), approx week 32 (4-month f/up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx week 8 (mid-treatment), approx. week 16 (post-treatment), approx week 20 (1-month f/up), approx week 32 (4-month f/up)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-Traumatic Stress Disorder
Secondary outcome measures
Mental Depression
Change in Beck Depression Inventory-II (BDI-II) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, 4-month post-treatment f/up
Change in Clinical Global Impression of Change - Symptoms and Improvement (CGI-Symptoms) from mid-treatment to post-treatment, 1-month post-treatment f/up, and 4-month post-treatment f/up
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged exposure with PE CoachExperimental Treatment1 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 CoachActive Control1 Intervention
Standard PE treatment protocol without PE Coach
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,160 Total Patients Enrolled
Defense Centers of Excellence for Psychological Health and Traumatic Brain InjuryFED
2 Previous Clinical Trials
195 Total Patients Enrolled
Greg M. Reger, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently in a dangerous situation, such as experiencing domestic violence.I am currently receiving recommended psychotherapy for PTSD.I have been diagnosed with PTSD with a severity score of 26 or higher.I haven't been stable on my mental health medications for 6 weeks.I do not have severe neurological conditions that could affect treatment.I have a condition that makes it hard for me to use a mobile device.You have thoughts of harming or killing yourself.I am willing to attend therapy sessions in person or via video call and use a mobile device for it.I have undergone 3 or more PE therapy sessions for PTSD.I am a veteran between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Prolonged exposure with PE Coach
- Group 2: Prolonged exposure without PE Coach
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial open to participants over sixty-five years of age?
"This study only accepts participants between the ages of 18 and 65. For those under 18, there are 46 trials available; for people over 65, 328 medical studies are currently listed."
Answered by AI
Are new participants being welcomed into this research endeavor?
"Clinicaltrials.gov attests that recruitment for this medical study is currently underway, commencing on July 29th 2022 and being revised as recently as September 6th 2022."
Answered by AI
Could I partake in this research project?
"Aspiring participants for this trial must be aged 18-65 and have a current diagnosis of PTSD according to the CAPS-5 criteria. Furthermore, they need to be Veterans registered in VA Healthcare who comprehend English fluently and are willing to participate in individual psychotherapy sessions either through face-to-face meetings or via telemental health proceedings which involve the usage of mobile devices."
Answered by AI
How many participants are currently being included in this trial?
"Confirmative, the clinical trial is currently recruiting. It was first published on July 29th and updated most recently on September 6th of this year; it requires 124 participants from a single medical site."
Answered by AI
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