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

Primary Purpose

PTSD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure for Primary Care (PE-PC)
Full Prolonged Exposure
Clinician Supported PTSD Coach App
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Prolonged Exposure for Primary Care, Mobile device, Clinician Supported PTSD Coach App, PTSD symptoms, Prolonged Exposure/PE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Family Health Care
  • Grace HealthRecruiting
  • Hamilton Community Health NetworkRecruiting
  • Cherry HealthRecruiting
  • MidMichigan Community Health ServicesRecruiting
  • Upper Great Lakes Family Health Care CenterRecruiting
  • Family Medical Center of MichiganRecruiting
  • Sterling Area Health CenterRecruiting
  • Family Care Health CentersRecruiting
  • Western North Carolina Community Health ServicesRecruiting
  • CommUnityCare Health CentersRecruiting
  • Unity Care NWRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Prolonged Exposure for Primary Care (PE-PC) then continue as early responder

Clinician Supported (CS) PTSD Coach App then continue as early responder

Prolonged Exposure for Primary Care (PE-PC) then full PE

Clinician Supported PTSD Coach App then full PE

Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC

Clinician Supported PTSD Coach App then continued CS PTSD Coach App

Arm Description

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).

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.

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.

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.

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.

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.

Outcomes

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)
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)
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)
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)
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.

Full Information

First Posted
July 11, 2022
Last Updated
September 4, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05457985
Brief Title
Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers
Official Title
Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
Prolonged Exposure for Primary Care, Mobile device, Clinician Supported PTSD Coach App, PTSD symptoms, Prolonged Exposure/PE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
Outcomes Assessor
Masking Description
The primary outcome, the Clinician-Administered PTSD Scale (CAP-5), will be administered by a blinded, study team member.
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure for Primary Care (PE-PC) then continue as early responder
Arm Type
Experimental
Arm Description
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).
Arm Title
Clinician Supported (CS) PTSD Coach App then continue as early responder
Arm Type
Experimental
Arm Description
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.
Arm Title
Prolonged Exposure for Primary Care (PE-PC) then full PE
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinician Supported PTSD Coach App then full PE
Arm Type
Experimental
Arm Description
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.
Arm Title
Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinician Supported PTSD Coach App then continued CS PTSD Coach App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure for Primary Care (PE-PC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Full Prolonged Exposure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinician Supported PTSD Coach App
Intervention Description
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 Measure Information:
Title
Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5)
Description
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.
Time Frame
Baseline, 3-months
Secondary Outcome Measure Information:
Title
Change in PTSD symptoms by the PTSD Checklist (PCL-5)
Description
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).
Time Frame
Baseline, 3-months
Title
Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Baseline, 3-months
Title
Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)
Description
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.
Time Frame
Baseline, 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Longuski, MS
Phone
734-647-6258
Email
kaylsmit@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Walters
Phone
734-845-3650
Email
heawalte@umich.edu
Facility Information:
Facility Name
Family Health Care
City
Baldwin
State/Province
Michigan
ZIP/Postal Code
49304
Country
United States
Individual Site Status
Terminated
Facility Name
Grace Health
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Macleod
First Name & Middle Initial & Last Name & Degree
Eric Macleod
Facility Name
Hamilton Community Health Network
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Ujkaj
First Name & Middle Initial & Last Name & Degree
Albert Ujkaj
Facility Name
Cherry Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Metts
First Name & Middle Initial & Last Name & Degree
Eric Achtyes
Facility Name
MidMichigan Community Health Services
City
Houghton Lake
State/Province
Michigan
ZIP/Postal Code
48629
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Gedeon
First Name & Middle Initial & Last Name & Degree
Stacey Gedeon
Facility Name
Upper Great Lakes Family Health Care Center
City
Menominee
State/Province
Michigan
ZIP/Postal Code
49858
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savanna Weber
First Name & Middle Initial & Last Name & Degree
Donald Simila
Facility Name
Family Medical Center of Michigan
City
Monroe
State/Province
Michigan
ZIP/Postal Code
48162
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Keith
First Name & Middle Initial & Last Name & Degree
Erica Keith
Facility Name
Sterling Area Health Center
City
Sterling
State/Province
Michigan
ZIP/Postal Code
48659
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda LaTulip
First Name & Middle Initial & Last Name & Degree
Linda LaTulip
Facility Name
Family Care Health Centers
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordanna Riebel
First Name & Middle Initial & Last Name & Degree
Jordanna Riebel
Facility Name
Western North Carolina Community Health Services
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Parsil
First Name & Middle Initial & Last Name & Degree
Jessica Parsil
Facility Name
CommUnityCare Health Centers
City
Austin
State/Province
Texas
ZIP/Postal Code
78702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Gause
First Name & Middle Initial & Last Name & Degree
Heather Gause
Facility Name
Unity Care NW
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Williams
First Name & Middle Initial & Last Name & Degree
Beth Williams

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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