Sustaining and Improving Clinicians' Use of Evidence-Based Psychotherapy (EBP) for PTSD

Not Applicable

Active, not recruiting

• Conditions: Post Traumatic Stress Disorder
• Interventions: Behavioral: Fidelity-oriented Learning Community; Behavioral: Quality Improvement Learning Community

• Registration Number: NCT02449421
• Lead Sponsor: Toronto Metropolitan University

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.

Study Timeline

• Study First Submitted: 2015-02-09
• Study Start: 2015-05-06
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-20
• Primary Completion: 2022-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

  1. Are 18 years or older
  2. Have a diagnosis of PTSD
  3. Are willing to have their sessions audiorecorded

Exclusion Criteria

• Ineligible patient participants are those having

  1. Current uncontrolled psychotic or bipolar disorder
  2. Unremitted substance dependence
  3. Current imminent suicidality or homicidality that requires imminent attention
  4. Significant cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fidelity-oriented Learning Community	Fidelity-oriented Learning Community	The Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings.
Quality Improvement Learning Community	Quality Improvement Learning Community	The Quality Improvement Learning Community arm will include clinicians who set goals related to CPT delivery, execute a plan, study results, refine plan, and continue each cycle until goals are met.

Primary Outcome Measures

Name	Time	Method
Change in PTSD Symptoms over 6 months (PCL-5 measure)	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 Outcome Measures

Name	Time	Method
Fidelity Measure	At baseline, at 12 and 24 months	The fidelity measure examines clinicians' adherence and competence to specific CPT interventions prescribed in each session. Clinicians are rated on their adherence to the protocol (on a 0-2 Likert-type scale), as well as their competence in delivery of these elements (rated on a 7-point, Likert-type scale).
Content-Level and Context-Level Adaptation	At baseline, at 12 and 24 months	Using a framework and coding system of modifications and adaptations made to EBPs, sessions will be rated to identify 11 potential content-level adaptations, as well as 5 context-level modifications.
CPT Activity Reporting	monthly for up to 1 year	All clinicians will report monthly on CPT activity: caseload size, frequency, duration and satisfaction with the LC over the past month, number of new CPT patients, clinician confidence rating in their CPT delivery.

Trial Locations

Locations (3)

UTHSCSA; 🇺🇸 San Antonio, California, United States

VA Palo Alto Healthcare System; 🇺🇸 Menlo Park, California, United States

Ryerson University; 🇨🇦 Toronto, Ontario, Canada