- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04765319
Delivery Considerations of Cognitive Processing Therapy for PTSD
Study Overview
Detailed Description
Background and Introduction Cognitive Processing Therapy (CPT) is an evidenced based psychotherapy for PTSD. It is considered a first line treatment and has ample evidence supporting it's effectiveness (ISTSS and VA/DOD clinical practice guidelines). This therapy is manualized and a framework is provided to ensure consistent delivery. Additionally, the VA Office of Mental Health Operations sponsors training and dissemination of CPT throughout the VA system and the PI of this study is a trainer and consultant of this therapy. Flexibility exists in the protocol and CPT can be delivered in unorthodox modalities such as telehealth (Moreland et al, 2015) and on compressed time schedules (Held et al, 2020; Bryan et al, 2018). While the literature supports the effectiveness of these interventions in unique settings, no known studies have looked at outcome data of real-world outpatient clinics. The PTSD Clinical Team provides CPT as part of it's standard care with a variety of adaptations. The team practices measurement based care and routinely collects self-report symptom inventories to track patient progress. This study aims to use data collected as part of standard care in this clinic to evaluate the effectiveness of these treatment adaptations in this setting.
Purpose and Objectives The purpose of this study is to explore the impact of how CPT for PTSD is delivered. Initial areas of review will include in person vs. telehealth delivery and timing (daily vs. weekly).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84148
- Salt Lake City VAMC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- PTSD diagnosis
- Veterans eligible for VA care
- Treatment seeking Veterans
Exclusion Criteria:
- PTSD not priority of treatment due to comorbidity, safety, etc. All patients that would be treated for PTSD in outpatient clinic are included.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Vets
Veterans receiving care from the PTSD Clinical Team at the Salt Lake City VAMC.
All participants are adults with a diagnosis of PTSD.
This study plans on reviewing data collected as part of standard clinical practices.
The study will have no impact on the treatment provided to the patient.
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Evidence based psychotherapy for PTSD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Checklist 5
Time Frame: Through study completion, an average of 12 sessions (3 months)
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Self report PTSD symptom inventory
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Through study completion, an average of 12 sessions (3 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PHQ-9
Time Frame: Through study completion, an average of 12 sessions (3 months)
|
Self report depression symptom inventory
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Through study completion, an average of 12 sessions (3 months)
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Collaborators and Investigators
Investigators
- Principal Investigator: Harrison R Weinstein, PhD, VA Salt Lake City
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB_00133139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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