Status:
ACTIVE_NOT_RECRUITING
Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
Lead Sponsor:
VA Office of Research and Development
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 se...
Detailed Description
Background: One third of post-9/11 Veterans in VHA suffer from posttraumatic stress disorder (PTSD), and among those who initiate Cognitive Processing Therapy (CPT), up to 70% drop out before receivin...
Eligibility Criteria
Inclusion
- The investigators designed the sample to be representative of Veterans with PTSD who are treated in PTSD Clinical Teams (PCTs), with minimal exclusion criteria. PCT clinicians will provide care for those with exclusionary comorbidities or preference for a medication-based approach, as per standard policies and procedures. Inclusion criteria are:
- score of 33 or above on the PCL-5
- at least 4 weeks on a stable dose for individuals who are taking psychotropic medication
- over the age of 18
Exclusion
- active suicidality (assessed by the Columbia Suicide Severity Rating Scale with scores indicating elevated acute risk for suicide warranting hospitalization or intensive treatment)
- need for detoxification
- severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can provide informed consent or 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)
- psychosis or unmanaged bipolar disorder
- previous receipt of CPT in the past year
- current engagement in trauma-focused psychotherapy (Prolonged Exposure or Cognitive Processing Therapy)
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT05220137
Start Date
August 1 2022
End Date
March 31 2026
Last Update
September 24 2025
Active Locations (3)
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1
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
2
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States, 45220-2213
3
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001