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NCT05457985 · ClinicalTrials.gov registry record · NA
Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers
A NA study of PTSD, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 430
- Enrollment target
- 13
- Study locations
NCT05457985: Recruiting NA study of PTSD, sponsored by University of Michigan.
NCT05457985 is a NA study of PTSD that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 430 participants, above the 299-participant average among 154 other PTSD trials with a reported enrollment target (44% higher). The trial reports 13 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05457985, a NA study of PTSD, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 430 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Prolonged Exposure for Primary Care (PE-PC)
- BEHAVIORAL Full Prolonged Exposure
- BEHAVIORAL Clinician Supported PTSD Coach App
Study Locations (13)
Michigan
- Family Health Care - Baldwin
- Grace Health - Battle Creek
- Genesee Community Health Center - Flint
- Hamilton Community Health Network - Flint
- Cherry Health - Grand Rapids
- MidMichigan Community Health Services - Houghton Lake
- Upper Great Lakes Family Health Care Center - Menominee
- Family Medical Center of Michigan - Monroe
- Sterling Area Health Center - Sterling
Missouri
- Family Care Health Centers - St Louis
North Carolina
- Western North Carolina Community Health Services - Asheville
Texas
- CommUnityCare Health Centers - Austin
Washington
- Unity Care NW - Bellingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2026-05 |
| Phase | NA |
What NCT05457985 shows while recruiting
NCT05457985 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, above the 299-participant average among 154 other PTSD trials with a reported enrollment target (44% higher).
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 3 interventions - of which Prolonged Exposure for Primary Care (PE-PC) is the first listed.
NCT05457985 lists 13 locations in 5 states (Michigan, Missouri, North Carolina).
Frequently Asked Questions
What is clinical trial NCT05457985 about?
NCT05457985 is a clinical study titled "Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers". 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 mo...
What is the current status of trial NCT05457985?
This trial is currently recruiting. It is a NA study. The enrollment target is 430 participants. The study started on 2022-06-23. Estimated completion is 2026-05.
What conditions does trial NCT05457985 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT05457985?
The interventions under investigation include: Prolonged Exposure for Primary Care (PE-PC) (BEHAVIORAL), Full Prolonged Exposure (BEHAVIORAL), Clinician Supported PTSD Coach App (BEHAVIORAL).
Who is sponsoring clinical trial NCT05457985?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05457985 being conducted?
This trial has 13 study locations across Michigan, Missouri, North Carolina, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05457985's enrollment target sits among peer trials
430 10th of 154 higher than 145 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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