Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
Family Health Care
TERMINATED
Baldwin
Grace Health
RECRUITING
Battle Creek
Genesee Community Health Center
RECRUITING
Flint
Hamilton Community Health Network
RECRUITING
Flint
Cherry Health
RECRUITING
Grand Rapids
MidMichigan Community Health Services
RECRUITING
Houghton Lake
Upper Great Lakes Family Health Care Center
RECRUITING
Menominee
Family Medical Center of Michigan
RECRUITING
Monroe
Sterling Area Health Center
RECRUITING
Sterling
Missouri
Family Care Health Centers
RECRUITING
St Louis
North Carolina
Western North Carolina Community Health Services
RECRUITING
Asheville
Texas
CommUnityCare Health Centers
RECRUITING
Austin
Washington
Unity Care NW
RECRUITING
Bellingham
Contact Information
Primary
Kayla Longuski, MS
kaylsmit@umich.edu
734-647-6258
Backup
Heather Walters
heawalte@umich.edu
734-845-3650
Time Frame
Start Date: 2022-06-23
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 430
Treatments
Experimental: Prolonged Exposure for Primary Care (PE-PC) then continue as early responder
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).
Experimental: Clinician Supported (CS) PTSD Coach App then continue as early responder
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 the remaining 8 weeks.
Experimental: Prolonged Exposure for Primary Care (PE-PC) then full PE
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 and 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.
Experimental: Clinician Supported PTSD Coach App then full PE
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.
Experimental: Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC
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.
Experimental: Clinician Supported PTSD Coach App then continued CS PTSD Coach App
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: University of Michigan

This content was sourced from clinicaltrials.gov

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