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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02449421
• Other study ID #: REB: 2014-345
• Secondary ID: 137012R01MH10650
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2015
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Toronto Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Quality Improvement Learning Community
Consultation with CPT experts to effectively use evidence-based psychotherapy.
• 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.

Locations

Country	Name	City	State
Canada	Ryerson University	Toronto	Ontario
United States	VA Palo Alto Healthcare System	Menlo Park	California
United States	UTHSCSA	San Antonio	California

Sponsors (6)

Lead Sponsor	Collaborator
Toronto Metropolitan University	Canadian Institutes of Health Research (CIHR), National Center for PTSD, National Institute of Mental Health (NIMH), Palo Alto Veterans Institute for Research, Stanford University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Symptoms over 6 months (PCL-5 measure)	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.	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.
Secondary	Fidelity Measure	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).	At baseline, at 12 and 24 months
Secondary	Content-Level and Context-Level Adaptation	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.	At baseline, at 12 and 24 months
Secondary	CPT Activity Reporting	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.	monthly for up to 1 year