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

NCT02449421 | Unknown DMC

• 3 other identifiers: REB: 2014-345137012R01MH106506-01
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 3

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.

Conditions

Post Traumatic Stress Disorder

Keywords

trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fidelity Measure

  At baseline, at 12 and 24 months

• Content-Level and Context-Level Adaptation

  At baseline, at 12 and 24 months

• CPT Activity Reporting

  monthly for up to 1 year

Study Arms (2)

Fidelity-oriented Learning Community

EXPERIMENTAL

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

Quality Improvement Learning Community

EXPERIMENTAL

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

Interventions

Quality Improvement Learning Community BEHAVIORAL

Consultation with CPT experts to effectively use evidence-based psychotherapy.

Quality Improvement Learning Community

Fidelity-oriented Learning Community BEHAVIORAL

The Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings.

Fidelity-oriented Learning Community

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Stanford University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• National Institute of Mental Health (NIMH): collaborator
• Palo Alto Veterans Institute for Research: collaborator
• National Center for PTSD: collaborator

Study Sites (3)

VA Palo Alto Healthcare System

Menlo Park, California, 94024, United States

Location

UTHSCSA

San Antonio, California, 78229, United States

Location

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (2)

• Thomas FC, Loskot T, Mutschler C, Burdo J, Lagdamen J, Sijercic I, Lane JEM, Liebman RE, Finley EP, Monson CM, Wiltsey-Stirman S. Initiating Cognitive Processing Therapy (CPT) in Community Settings: A Qualitative Investigation of Therapist Decision-Making. Adm Policy Ment Health. 2023 Jan;50(1):137-150. doi: 10.1007/s10488-022-01229-8. Epub 2022 Nov 12.

  PMID: 36370226 DERIVED

• 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.

  PMID: 28264720 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Candice Monson, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

• Shannon Wiltsey Stirman, PhD

  National Center for PTSD

  PRINCIPAL INVESTIGATOR

• Norman Shields, PhD

  Royal Canadian Mounted Police

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: May 20, 2015
• Study Start: May 6, 2015
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)