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

NCT ID: NCT02449421

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-06

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fidelity-oriented Learning Community

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Quality Improvement Learning Community

Intervention Type BEHAVIORAL

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

Interventions

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Quality Improvement Learning Community

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role collaborator

National Center for PTSD

FED

Sponsor Role collaborator

Toronto Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Candice Monson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Candice Monson, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Shannon Wiltsey Stirman, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for PTSD

Norman Shields, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Canadian Mounted Police

Locations

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VA Palo Alto Healthcare System

Menlo Park, California, United States

Site Status

UTHSCSA

San Antonio, California, United States

Site Status

Ryerson University

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 36370226 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28264720 (View on PubMed)

Other Identifiers

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137012

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R01MH106506-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

REB: 2014-345

Identifier Type: -

Identifier Source: org_study_id

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