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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Fidelity-oriented Learning Community; Behavioral: Quality Improvement Learning Community

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 2K3
      • Ryerson University
• United States
  • California
    • Menlo Park, California, United States, 94024
      • VA Palo Alto Healthcare System
    • San Antonio, California, United States, 78229
      • UTHSCSA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: Quality Improvement Learning Community; Consultation with CPT experts to effectively use evidence-based psychotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Toronto Metropolitan University
• Collaborators: National Institute of Mental Health (NIMH); Canadian Institutes of Health Research (CIHR); Stanford University; Palo Alto Veterans Institute for Research; National Center for PTSD
• Investigators: Principal Investigator: Shannon Wiltsey Stirman, PhD, National Center for PTSD; Principal Investigator: Norman Shields, PhD, Royal Canadian Mounted Police; Principal Investigator: Candice Monson, PhD, Toronto Metropolitan University

Publications and helpful links

General Publications

• Wiltsey Stirman S, Finley EP, Shields N, Cook J, Haine-Schlagel R, Burgess JF Jr, Dimeff L, Koerner K, Suvak M, Gutner CA, Gagnon D, Masina T, Beristianos M, Mallard K, Ramirez V, Monson C. Improving and sustaining delivery of CPT for PTSD in mental health systems: a cluster randomized trial. Implement Sci. 2017 Mar 6;12(1):32. doi: 10.1186/s13012-017-0544-5.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2015
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimated): May 20, 2015

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: trauma
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: REB: 2014-345; 137012 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR)); R01MH106506-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD.