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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04765319
Other study ID # IRB_00133139
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2024

Study information

Verified date February 2021
Source VA Salt Lake City Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Review treatment outcomes of modifications to standard delivery of CPT for PTSD that are delivered as routine care at in VA outpatient clinic.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date August 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CPT for PTSD
Evidence based psychotherapy for PTSD

Locations

Country Name City State
United States Salt Lake City VAMC Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTSD Checklist 5 Self report PTSD symptom inventory Through study completion, an average of 12 sessions (3 months)
Secondary PHQ-9 Self report depression symptom inventory Through study completion, an average of 12 sessions (3 months)
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