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Clinical Trials/NCT02449421
NCT02449421
Active, not recruiting
Not Applicable

A Comparison of the Effects of Internet-Based Strategies to Support Mental Health Clinicians' Use of an Effective Psychotherapy for Post Traumatic Stress Disorder (PTSD) in Mental Health Systems

Toronto Metropolitan University3 sites in 2 countries90 target enrollmentMay 6, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
Toronto Metropolitan University
Enrollment
90
Locations
3
Primary Endpoint
Change in PTSD Symptoms over 6 months (PCL-5 measure)
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The purpose of the study is to compare the impact of two strategies to sustain and improve the delivery of an evidence-based psychotherapy for PTSD, Cognitive Processing Therapy (CPT) in three different mental health systems. These approaches are based on two different theories of what is necessary to promote successful implementation. We will examine whether these strategies lead to improved patient outcomes, clinician skill, proportion of clients who receive CPT, and other outcomes that are relevant to the implementation of evidence-based psychosocial treatments. By examining these questions in 3 different mental health systems, we will also examine whether the implementation strategies yield different results in different systems.

Detailed Description

This project will compare two different methods of post-training support to promote sustained and improved CPT delivery: Fidelity-oriented learning community (FID-LC) and Continuous Quality Improvement Learning Community (CQI-LC). Clinics in which clinicians have previously received CPT training will be randomly assigned to one of these conditions. Outcomes will be observed changes in patient symptoms during and following treatment, independent expert assessment of clinician fidelity and adaptations in delivering the psychotherapy (via audio-recordings), proportion of eligible caseloads that receive CPT, and capacity to deliver CPT. Data will also be collected to assess clinician and setting characteristics that may contribute to the success of each strategy. The study results will help inform how best to support the ongoing implementation and benefits of evidence-based psychotherapy (e.g., CPT) in routine clinical settings. This is a knowledge translation project in partnership with 3 systems; VA Canada, U.S. Veterans Health Care System and the National Centre for PTSD.

Registry
clinicaltrials.gov
Start Date
May 6, 2015
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Candice Monson

Professor

Toronto Metropolitan University

Eligibility Criteria

Inclusion Criteria

  • All clinicians that provide psychotherapy to patients with PTSD
  • Agree to provide CPT to 6 patients over 2 years
  • Consent to be randomized to one of two study conditions
  • Are willing to record therapy sessions
  • Continue to have computer/internet access.
  • Patients will be clients of clinician participants that
  • Are 18 years or older
  • Have a diagnosis of PTSD
  • Are willing to have their sessions audiorecorded

Exclusion Criteria

  • Ineligible patient participants are those having
  • Current uncontrolled psychotic or bipolar disorder
  • Unremitted substance dependence
  • Current imminent suicidality or homicidality that requires imminent attention
  • Significant cognitive impairment

Outcomes

Primary Outcomes

Change in PTSD Symptoms over 6 months (PCL-5 measure)

Time Frame: Participants will be followed for an expected duration of 12 weeks of therapy. PCL-5 will be measured at baseline, at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, post-treatment week, and at 3-month follow-up.

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is measured on a 5-point Likert scale. The PCL will track change from baseline to the 3 month follow up.

Secondary Outcomes

  • Fidelity Measure(At baseline, at 12 and 24 months)
  • Content-Level and Context-Level Adaptation(At baseline, at 12 and 24 months)
  • CPT Activity Reporting(monthly for up to 1 year)

Study Sites (3)

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