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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-months for reporting.

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

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

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