Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PTSD
- Sponsor
- University of Michigan
- Enrollment
- 430
- Locations
- 13
- 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)
- Status
- Recruiting
- Last Updated
- 8 months ago
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.
Investigators
Rebecca Sripada
Associate Professor of Psychiatry
University of Michigan
Eligibility Criteria
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.
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)