Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers

University of Michigan

Status: Enrolling

Conditions: PTSD

Treatments: Behavioral: Clinician Supported PTSD Coach App; Behavioral: Prolonged Exposure for Primary Care (PE-PC); Behavioral: Full Prolonged Exposure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05457985

HUM00203165

1R01MH125857-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.

The central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receive care at a participating federally qualified health center (FQHC)
• Have a Posttraumatic Stress Disorder checklist (PCL-5) score greater or equal (≥) to 33
• Own a mobile device that can be used for the PTSD Coach App
• Have had psychotropic medication stability for at least 4 weeks

Exclusion criteria

• Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
• High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form
• Severe alcohol or substance use disorder (moderate-severe alcohol use disorder on Alcohol Use Disorders Identification Test (AUDIT) (scores ≥ 15) or high risk on National Institute on Drug Abuse Quick Screen (scores ≥ 27))
• Active psychosis or unmanaged bipolar disorder
• Unstable housing
• Current engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
• Patients who do not speak English will be excluded for logistical reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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430 participants in 6 patient groups

Prolonged Exposure for Primary Care (PE-PC) then continue as early responder

Experimental group

Description:

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).

Treatment:

Behavioral: Prolonged Exposure for Primary Care (PE-PC)

Clinician Supported (CS) PTSD Coach App then continue as early responder

Experimental group

Description:

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:

Behavioral: Clinician Supported PTSD Coach App

Prolonged Exposure for Primary Care (PE-PC) then full PE

Experimental group

Description:

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.

Treatment:

Behavioral: Full Prolonged Exposure

Behavioral: Prolonged Exposure for Primary Care (PE-PC)

Clinician Supported PTSD Coach App then full PE

Experimental group

Description:

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.

Treatment:

Behavioral: Full Prolonged Exposure

Behavioral: Clinician Supported PTSD Coach App

Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC

Experimental group

Description:

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.

Treatment:

Behavioral: Prolonged Exposure for Primary Care (PE-PC)

Clinician Supported PTSD Coach App then continued CS PTSD Coach App

Experimental group

Description:

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.

Treatment:

Behavioral: Clinician Supported PTSD Coach App