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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457985
• Other study ID #: HUM00203165
• Secondary ID: 1R01MH125857-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: May 2026

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: Kayla Longuski, MS
• Phone: 734-647-6258
• Email: kaylsmit[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Prolonged Exposure for Primary Care (PE-PC)
Treatment follows the standardized PE-PC manual and workbook.PE-PC consists of four weekly 30-minute sessions. In vivo and imaginal exposure are introduced at the first session and reviewed at Sessions 2-4. To conduct in vivo exposure, participants repeatedly and systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. 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.
• Full Prolonged Exposure
Treatment will follow the standardized PE manual. Participants will have 60 minute sessions once a week for eight weeks During these sessions, participants will practice in vivo, imaginal, and emotional exposure as well as continue these exposure exercises every day at home.
• Clinician Supported PTSD Coach App
This is a brief psychotherapy that uses the PTSD Coach mobile app developed by the study team. The PTSD Coach app incorporates evidence-based assessment, psychoeducation, and cognitive behavioral therapy and self-management strategies that are customizable to the user.

Locations

Country	Name	City	State
United States	Western North Carolina Community Health Services	Asheville	North Carolina
United States	CommUnityCare Health Centers	Austin	Texas
United States	Family Health Care	Baldwin	Michigan
United States	Grace Health	Battle Creek	Michigan
United States	Unity Care NW	Bellingham	Washington
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	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	Sterling Area Health Center	Sterling	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5)	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.	Baseline, 3-months
Secondary	Change in PTSD symptoms by the PTSD Checklist (PCL-5)	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).	Baseline, 3-months
Secondary	Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)	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.	Baseline, 3-months
Secondary	Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)	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.	Baseline, 3-months