Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers
- Conditions
- PTSD
- Interventions
- Behavioral: Clinician Supported PTSD Coach AppBehavioral: Prolonged Exposure for Primary Care (PE-PC)Behavioral: Full Prolonged Exposure
- Registration Number
- NCT05457985
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 430
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Clinician Supported (CS) PTSD Coach App then continue as early responder Clinician Supported PTSD Coach App 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. Prolonged Exposure for Primary Care (PE-PC) then full PE Prolonged Exposure for Primary Care (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 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. Clinician Supported PTSD Coach App then full PE Clinician Supported 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 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. Prolonged Exposure for Primary Care (PE-PC) then full PE Full Prolonged Exposure 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. Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC Prolonged Exposure for Primary Care (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. Prolonged Exposure for Primary Care (PE-PC) then continue as early responder Prolonged Exposure for Primary Care (PE-PC) 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). Clinician Supported PTSD Coach App then full PE Full Prolonged Exposure 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. Clinician Supported PTSD Coach App then continued CS PTSD Coach App Clinician Supported 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.
- Primary Outcome Measures
Name Time Method Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5) 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 Outcome Measures
Name Time Method Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9) Baseline, 3-months There are 9 questions that reflects the overall functioning and impairment due to the depressive symptoms. Scores ranges from 0 to 27, with a higher score indicating more severe symptoms.
Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L) Baseline, 3-months The EQ-5D-5L assesses patients' overall quality of life and health. This measure asks questions related to mobility, self-care, activity, pain, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. The participant indicates his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension. The measure also includes one 0-100 scale assessing how patients perceive their overall health.
Change in PTSD symptoms by the PTSD Checklist (PCL-5) Baseline, 3-months The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment. The minimum score is 0, the maximum is 80 (higher scores indicate increased PTSD severity).
Trial Locations
- Locations (13)
Family Health Care
🇺🇸Baldwin, Michigan, United States
Grace Health
🇺🇸Battle Creek, Michigan, United States
Genesee Community Health Center
🇺🇸Flint, Michigan, United States
Hamilton Community Health Network
🇺🇸Flint, Michigan, United States
Cherry Health
🇺🇸Grand Rapids, Michigan, United States
MidMichigan Community Health Services
🇺🇸Houghton Lake, Michigan, United States
Sterling Area Health Center
🇺🇸Sterling, Michigan, United States
Upper Great Lakes Family Health Care Center
🇺🇸Menominee, Michigan, United States
Family Medical Center of Michigan
🇺🇸Monroe, Michigan, United States
Family Care Health Centers
🇺🇸Saint Louis, Missouri, United States
CommUnityCare Health Centers
🇺🇸Austin, Texas, United States
Western North Carolina Community Health Services
🇺🇸Asheville, North Carolina, United States
Unity Care NW
🇺🇸Bellingham, Washington, United States