RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-23
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05457985

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Receive care at a participating federally qualified health center (FQHC)
  2. * Have a Posttraumatic Stress Disorder checklist (PCL-5) score greater or equal (≥) to 33
  3. * Own a mobile device that can be used for the PTSD Coach App
  4. * Have had psychotropic medication stability for at least 4 weeks
  1. * 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)
  2. * High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form
  3. * 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))
  4. * Active psychosis or unmanaged bipolar disorder
  5. * Unstable housing
  6. * Current engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
  7. * Patients who do not speak English will be excluded for logistical reasons.

Contacts and Locations

Study Contact

Kayla Longuski, MS
CONTACT
734-647-6258
kaylsmit@umich.edu
Heather Walters
CONTACT
734-845-3650
heawalte@umich.edu

Study Locations (Sites)

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
Saint 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

Collaborators and Investigators

Sponsor: University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-23
Study Completion Date2026-05

Study Record Updates

Study Start Date2022-06-23
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Prolonged Exposure for Primary Care
  • Mobile device
  • Clinician Supported PTSD Coach App
  • PTSD symptoms
  • Prolonged Exposure/PE

Additional Relevant MeSH Terms

  • PTSD