Clinical trial NCT02449421: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: trauma
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Canadian Institutes of Health Research (CIHR)
name: National Institute of Mental Health (NIMH)
name: Palo Alto Veterans Institute for Research
name: National Center for PTSD
First posted: 2015-05-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

  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

Primary outcomes:
measure: Change in PTSD Symptoms over 6 months (PCL-5 measure)
timeFrame: 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:
measure: Fidelity Measure
timeFrame: At baseline, at 12 and 24 months
measure: Content-Level and Context-Level Adaptation
timeFrame: At baseline, at 12 and 24 months
measure: CPT Activity Reporting
timeFrame: monthly for up to 1 year
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: VA Palo Alto Healthcare System
state: California
city: San Antonio
country: United States
facility: UTHSCSA
state: California
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Candice Monson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for PTSD
name: Shannon Wiltsey Stirman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Canadian Mounted Police
name: Norman Shields, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.