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

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ClinicalTrials.gov Identifier: NCT05457985
Recruitment Status : Recruiting
First Posted : July 14, 2022
Last Update Posted : July 14, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rebecca Sripada, 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.


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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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 : June 23, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in PTSD symptoms by the PTSD Checklist (PCL-5) [ Time Frame: 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).

  2. Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9) [ Time Frame: 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.

  3. Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05457985


Contacts
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Contact: Kayla Smith, MS 734-647-6258 kaylsmit@umich.edu
Contact: Heather Walters 734-845-3650 heawalte@umich.edu

Locations
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United States, Michigan
Family Health Care Recruiting
Baldwin, Michigan, United States, 49304
Contact: Rebecca London         
Principal Investigator: Rebecca London         
Grace Health Recruiting
Battle Creek, Michigan, United States, 49037
Contact: Eric Macleod         
Principal Investigator: Eric Macleod         
Hamilton Community Health Network Recruiting
Flint, Michigan, United States, 48503
Contact: Tauheed Hasan         
Principal Investigator: Tauheed Hasan         
Cherry Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Lindsey Metts         
Principal Investigator: Eric Achtyes         
Upper Great Lakes Family Health Care Center Recruiting
Menominee, Michigan, United States, 49858
Contact: Savanna Weber         
Principal Investigator: Donald Simila         
Family Medical Center of Michigan Recruiting
Monroe, Michigan, United States, 48162
Contact: Erica Keith         
Principal Investigator: Erica Keith         
Sterling Area Health Center Recruiting
Sterling, Michigan, United States, 48659
Contact: Linda LaTulip         
Principal Investigator: Linda LaTulip         
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
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Responsible Party: Rebecca Sripada, Assistant Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT05457985    
Other Study ID Numbers: HUM00203165
1R01MH125857-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Sripada, University of Michigan:
Prolonged Exposure for Primary Care
Mobile device
Clinician Supported PTSD Coach App
PTSD symptoms
Prolonged Exposure/PE
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders