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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-months
Awards & highlights
Study Summary
This trial is testing a new way to do talk therapy for PTSD that could be more helpful than current methods.
Who is the study for?
This trial is for individuals with PTSD receiving care at certain Michigan health centers, who score ≥33 on the PTSD checklist and have stable psychotropic medication use for 4 weeks. They must own a mobile device compatible with the PTSD Coach App. Excluded are those currently in trauma-focused treatment, with severe cognitive impairment, non-English speakers, high suicide risk, active psychosis or unmanaged bipolar disorder, severe substance abuse issues, or unstable housing.Check my eligibility
What is being tested?
The study tests a stepped-care talk therapy model for PTSD patients by starting them on different therapies and potentially switching after four sessions based on their response. It compares beginning with either Clinician Supported PTSD Coach App or Prolonged Exposure for Primary Care (PE-PC), and then possibly moving to Full Prolonged Exposure.See study design
What are the potential side effects?
While specific side effects are not listed for these interventions as they are forms of therapy rather than medications, participants may experience emotional discomfort or increased distress related to discussing traumatic events during the course of treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental disorders
Secondary outcome measures
Post-Traumatic Stress Disorder
Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)
Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)
Trial Design
6Treatment groups
Experimental Treatment
Group I: Prolonged Exposure for Primary Care (PE-PC) then full PEExperimental Treatment2 Interventions
PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to full PE will have sessions once a week for eight weeks. During these 60 minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.
Group II: Prolonged Exposure for Primary Care (PE-PC) then continued PE-PCExperimental Treatment1 Intervention
PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to continue with PE-PC (medium intensity) will continue weekly sessions for 8 weeks.
Group III: Prolonged Exposure for Primary Care (PE-PC) then continue as early responderExperimental Treatment1 Intervention
PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage (for 8 weeks).
Group IV: Clinician Supported PTSD Coach App then full PEExperimental Treatment2 Interventions
During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to full PE will have sessions once a week for eight weeks. During these 60 minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.
Group V: Clinician Supported PTSD Coach App then continued CS PTSD Coach AppExperimental Treatment1 Intervention
During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to continue this treatment will have the frequency reduced to twice monthly.
Group VI: Clinician Supported (CS) PTSD Coach App then continue as early responderExperimental Treatment1 Intervention
During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first). Early responders will be encouraged to continue app use but will discontinue clinician support sessions for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prolonged Exposure for Primary Care (PE-PC)
2019
N/A
~120
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,628 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,337 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in therapy for trauma, like Prolonged Exposure or Cognitive Processing Therapy.You are a patient of a participating FQHC.I speak English.My mental health medication has been stable for over a month.You have a mobile device that can run the PTSD Coach App.
Research Study Groups:
This trial has the following groups:- Group 1: Clinician Supported PTSD Coach App then full PE
- Group 2: Prolonged Exposure for Primary Care (PE-PC) then continue as early responder
- Group 3: Clinician Supported (CS) PTSD Coach App then continue as early responder
- Group 4: Prolonged Exposure for Primary Care (PE-PC) then full PE
- Group 5: Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC
- Group 6: Clinician Supported PTSD Coach App then continued CS PTSD Coach App
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.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05457985 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widespread is the implementation of this trial?
"At present, the clinical trial is enrolling patients at 7 distinct locations. These are situated in Baldwin, Monroe and Sterling along with 4 other areas. To limit travel time for participants, it's recommended to select a site that's close to you when signing up for this study."
Answered by AI
Is it feasible to join this trial at this point in time?
"Affirmative. According to the information accessible on clinicaltrials.gov, this trial is actively searching for enrollees and was initially published on June 23rd 2022 with its latest update taking place July 11th that same year. In total, 430 subjects will be admitted at 7 different sites of research."
Answered by AI
How many participants has this clinical trial attracted?
"Correct. Evidence from clinicaltrials.gov indicates that this medical study, first posted on June 23rd 2022, is still open for recruitment purposes. 430 participants have to be sourced from 7 different sites in order for the trial to commence."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
How old are they?
18 - 65
What site did they apply to?
Family Health Care
Hamilton Community Health Network
CommUnityCare Health Centers
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
Nothing is working. I hope healing from trauma evolves.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Hamilton Community Health Network: < 48 hours
Average response time
- < 2 Days
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