Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Michigan
- Enrollment
- 430
- Locations
- 26
- Primary Endpoint
- Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The primary outcome, the Clinician-Administered PTSD Scale (CAP-5), will be administered by a blinded study team member.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Prolonged Exposure for Primary Care (PE-PC) then continue as early responder
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).
Intervention: Prolonged Exposure for Primary Care (PE-PC) (Behavioral)
Prolonged Exposure for Primary Care (PE-PC) then full PE
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 and 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.
Intervention: Prolonged Exposure for Primary Care (PE-PC) (Behavioral)
Prolonged Exposure for Primary Care (PE-PC) then full PE
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 and 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.
Intervention: Full Prolonged Exposure (Behavioral)
Clinician Supported PTSD Coach App then full PE
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.
Intervention: Full Prolonged Exposure (Behavioral)
Clinician Supported PTSD Coach App then full PE
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.
Intervention: Clinician Supported PTSD Coach App (Behavioral)
Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC
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.
Intervention: Prolonged Exposure for Primary Care (PE-PC) (Behavioral)
Clinician Supported PTSD Coach App then continued CS PTSD Coach App
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.
Intervention: Clinician Supported PTSD Coach App (Behavioral)
Clinician Supported (CS) PTSD Coach App then continue as early responder
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 the remaining 8 weeks.
Intervention: Clinician Supported PTSD Coach App (Behavioral)
Outcomes
Primary Outcomes
Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5)
Time Frame: Baseline, 3-months
The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.
Secondary Outcomes
- Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)(Baseline, 3-months)
- Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)(Baseline, 3-months)
- Change in PTSD symptoms by the PTSD Checklist (PCL-5)(Baseline, 3-months)
Investigators
Rebecca Sripada
Associate Professor of Psychiatry
University of Michigan