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Adaptive PTSD Interventions for PTSD
N/A
Recruiting
Research Sponsored by University of Michigan
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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mental disorders
Secondary study objectives
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,863 Previous Clinical Trials
6,441,151 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,741,583 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