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

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05457985

Collaborator

National Institute of Mental Health (NIMH) (NIH)

430

Enrollment

Locations

Arms

35.3

Anticipated Duration (Months)

61.4

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD	Behavioral: Prolonged Exposure for Primary Care (PE-PC) Behavioral: Full Prolonged Exposure Behavioral: Clinician Supported PTSD Coach App	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

430 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

All eligible participants will initially be randomized to one of the two first-stage options, either PE-PC or PTSD coach with clinician support. Participants that have experienced less than a 15-point reduction, have a PCL score of greater than 60 ("very severe"), or cannot be reached for assessment will be classified as slow responders and will be re-randomized to one of two second-stage tactics, either (a) continue in their first-stage treatment strategy, or (b) step up to full PE. Participants who have experienced at least a 15-point symptom reduction or have a PCL score of less than 29 will be classified as early responders and will step down to a lower intensity of their current treatment strategy (i.e., early responders will not be re-randomized).All eligible participants will initially be randomized to one of the two first-stage options, either PE-PC or PTSD coach with clinician support. Participants that have experienced less than a 15-point reduction, have a PCL score of greater than 60 ("very severe"), or cannot be reached for assessment will be classified as slow responders and will be re-randomized to one of two second-stage tactics, either (a) continue in their first-stage treatment strategy, or (b) step up to full PE. Participants who have experienced at least a 15-point symptom reduction or have a PCL score of less than 29 will be classified as early responders and will step down to a lower intensity of their current treatment strategy (i.e., early responders will not be re-randomized).

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 23, 2022

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 6-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).	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 6-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage.
Experimental: 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 6 weeks (whichever occurs first). Early responders will be encouraged to continue app use but will discontinue clinician support sessions for 8 weeks.	Behavioral: 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.
Experimental: Prolonged Exposure for Primary Care (PE-PC) then full PE PE-PC consists of four weekly 30-minute sessions. At the 4th session or 6-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.	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 6-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage. Behavioral: 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.
Experimental: Clinician Supported PTSD Coach App then full PE During the first stage of treatment, participants will receive four weekly clinician support sessions or 6 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.	Behavioral: 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. Behavioral: 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.
Experimental: 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 6-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.	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 6-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage.
Experimental: 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 6 weeks (whichever occurs first), slow responders that are then randomized to continue this treatment will have the frequency reduced to twice monthly.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Receive care at a participating Michigan federally qualified community 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Family Health Care	Baldwin	Michigan	United States	49304
2	Grace Health	Battle Creek	Michigan	United States	49037
3	Hamilton Community Health Network	Flint	Michigan	United States	48503
4	Cherry Health	Grand Rapids	Michigan	United States	49503
5	Upper Great Lakes Family Health Care Center	Menominee	Michigan	United States	49858
6	Family Medical Center of Michigan	Monroe	Michigan	United States	48162
7	Sterling Area Health Center	Sterling	Michigan	United States	48659