Sustaining and Improving Clinicians' Use of Evidence-Based Psychotherapy (EBP) for PTSD
Primary Purpose
Post Traumatic Stress Disorder
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Quality Improvement Learning Community
Fidelity-oriented Learning Community
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring trauma
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
Sites / Locations
- VA Palo Alto Healthcare System
- UTHSCSA
- Ryerson University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fidelity-oriented Learning Community
Quality Improvement Learning Community
Arm Description
The Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
Full Information
NCT ID
NCT02449421
First Posted
February 9, 2015
Last Updated
April 27, 2023
Sponsor
Toronto Metropolitan University
Collaborators
Stanford University, Canadian Institutes of Health Research (CIHR), National Institute of Mental Health (NIMH), Palo Alto Veterans Institute for Research, National Center for PTSD
1. Study Identification
Unique Protocol Identification Number
NCT02449421
Brief Title
Sustaining and Improving Clinicians' Use of Evidence-Based Psychotherapy (EBP) for PTSD
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 6, 2015 (Actual)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
Stanford University, Canadian Institutes of Health Research (CIHR), National Institute of Mental Health (NIMH), Palo Alto Veterans Institute for Research, National Center for PTSD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fidelity-oriented Learning Community
Arm Type
Experimental
Arm Description
The Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings.
Arm Title
Quality Improvement Learning Community
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Quality Improvement Learning Community
Intervention Description
Consultation with CPT experts to effectively use evidence-based psychotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Fidelity-oriented Learning Community
Intervention Description
The Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings.
Primary Outcome Measure Information:
Title
Change in PTSD Symptoms over 6 months (PCL-5 measure)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Fidelity Measure
Description
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).
Time Frame
At baseline, at 12 and 24 months
Title
Content-Level and Context-Level Adaptation
Description
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.
Time Frame
At baseline, at 12 and 24 months
Title
CPT Activity Reporting
Description
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.
Time Frame
monthly for up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candice Monson, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shannon Wiltsey Stirman, PhD
Organizational Affiliation
National Center for PTSD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norman Shields, PhD
Organizational Affiliation
Royal Canadian Mounted Police
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Healthcare System
City
Menlo Park
State/Province
California
ZIP/Postal Code
94024
Country
United States
Facility Name
UTHSCSA
City
San Antonio
State/Province
California
ZIP/Postal Code
78229
Country
United States
Facility Name
Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD.
Citations:
PubMed Identifier
28264720
Citation
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.
Results Reference
derived
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Sustaining and Improving Clinicians' Use of Evidence-Based Psychotherapy (EBP) for PTSD
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