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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02449421
Recruitment Status : Enrolling by invitation
First Posted : May 20, 2015
Last Update Posted : March 10, 2020
Sponsor:
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
Information provided by (Responsible Party):
Candice Monson, Ryerson 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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: Quality Improvement Learning Community Behavioral: Fidelity-oriented Learning Community Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 6, 2015
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Fidelity Measure [ Time Frame: 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).

  2. Content-Level and Context-Level Adaptation [ Time Frame: 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.

  3. CPT Activity Reporting [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449421


Locations
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United States, California
VA Palo Alto Healthcare System
Menlo Park, California, United States, 94024
UTHSCSA
San Antonio, California, United States, 78229
Canada, Ontario
Ryerson University
Toronto, Ontario, Canada, M5B 2K3
Sponsors and Collaborators
Ryerson University
Stanford University
Canadian Institutes of Health Research (CIHR)
National Institute of Mental Health (NIMH)
Palo Alto Veterans Institute for Research
National Center for PTSD
Investigators
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Principal Investigator: Candice Monson, PhD Ryerson University
Principal Investigator: Shannon Wiltsey Stirman, PhD National Center for PTSD
Principal Investigator: Norman Shields, PhD Royal Canadian Mounted Police

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Candice Monson, Professor, Ryerson University
ClinicalTrials.gov Identifier: NCT02449421    
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 )
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD.
Keywords provided by Candice Monson, Ryerson University:
trauma
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders