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NCT05457985NARecruiting

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

University of Michigan

Start Date

6/23/2022

Completion Date

9/30/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BEHAVIORAL

Prolonged Exposure for Primary Care (PE-PC)

BEHAVIORAL

Full Prolonged Exposure

BEHAVIORAL

Clinician Supported PTSD Coach App

Interested in This Trial?

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Conditions

PTSD

Locations

Family Health Care

Baldwin, Michigan 49304

United States

Grace Health

Battle Creek, Michigan 49037

United States

Genesee Community Health Center

Flint, Michigan 48503

United States

Hamilton Community Health Network

Flint, Michigan 48503

United States

Cherry Health

Grand Rapids, Michigan 49503

United States

MidMichigan Community Health Services

Houghton Lake, Michigan 48629

United States

Upper Great Lakes Family Health Care Center

Menominee, Michigan 49858

United States

Family Medical Center of Michigan

Monroe, Michigan 48162

United States

Sterling Area Health Center

Sterling, Michigan 48659

United States

Family Care Health Centers

St Louis, Missouri 63111

United States

Western North Carolina Community Health Services

Asheville, North Carolina 28801

United States

CommUnityCare Health Centers

Austin, Texas 78702

United States

Unity Care NW

Bellingham, Washington 98225

United States