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

University of Michigan430 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

430

Conditions

PTSD

Interventions

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 ExposureBEHAVIORAL

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 AppBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

Family Health Care

Baldwin, Michigan, United States

TERMINATED

Grace Health

Battle Creek, Michigan, United States

RECRUITING

Genesee Community Health Center

Flint, Michigan, United States

RECRUITING

Hamilton Community Health Network

Flint, Michigan, United States

RECRUITING

Cherry Health

Grand Rapids, Michigan, United States

RECRUITING

MidMichigan Community Health Services

Houghton Lake, Michigan, United States

RECRUITING

Upper Great Lakes Family Health Care Center

Menominee, Michigan, United States

RECRUITING

Family Medical Center of Michigan

Monroe, Michigan, United States

RECRUITING

Sterling Area Health Center

Sterling, Michigan, United States

RECRUITING

Family Care Health Centers

St Louis, Missouri, United States

RECRUITING

...and 3 more locations

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 3-months

Secondary Outcomes

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).

Time frame: Baseline, 3-months

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.

Time frame: Baseline, 3-months

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.

Time frame: Baseline, 3-months

Central Contacts

Kayla Longuski, MS

CONTACT

734-647-6258 kaylsmit@umich.edu

Heather Walters

CONTACT

734-845-3650 heawalte@umich.edu