Clinical trial NCT04002050: Creating Resilient Workplaces Study
Official title: Cognitive Behaviour Therapy With Mindfulness Course for Building Workplace Resilience: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Anxiety Disorders
Depression
Stress Disorders, Posttraumatic
Keywords: Resilience
Workplace Engagement
Public Safety Personnel
Stress Disorders
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study aims to understand the impact of a 5-Class CBTm Course on variables contributing to workplace resilience among Public Safety Personnel (PSP). This involves examining the impact of the CBTm Course on prevention of PTSD and related conditions among PSPs. This research project will be undertaken using a randomized-controlled trial design. Questionnaires will be completed 1) before taking the course, 2) during the course, 3) after the course, and 4) at three-month follow-up.

Detailed description: The current proposal plans to implement and evaluate a CBT intervention for building workplace resilience by preventing symptoms of PTSD and related conditions in Public Safety Personnel (i.e., police officers, firefighters, paramedics, emergency communications, and correctional officers), in Manitoba, Canada. The intervention used in this study is the Cognitive Behaviour Therapy with Mindfulness (CBTm) Course.

Participants will be randomized into either the intervention group (CBTm) arm or the comparison arm. Participants placed in the intervention arm will be invited to immediately participate in the CBT intervention. Participants in the comparison arm will be placed on a 3-month waiting-list and will be invited to attend the CBT intervention following completion of the study. While placed in the comparison arm, participants may access the usual mental health supports that are normally offered through their respective occupational organizations, EAP programs, and other programs in the community.

Those who do not meet eligibility criteria will not be enrolled into the study, but will still be invited to attend the CBTm classes as space allows. Ineligible participants will not be randomized and their data will not be used in our analysis of the trial.

The Cognitive Behaviour Therapy with Mindfulness (CBTm) Course for Public Safety Personnel is a brief psychoeducational course consisting of 5 classes (90 minutes each) occurring on a weekly basis. The CBTm course addresses the fundamentals of CBT and provides participants with practical strategies for managing stress (such as relaxation strategies, cognitive restructuring, goal setting, behavioural activation, and exposure therapy). The sessions will be facilitated by a mental health-professional (i.e. psychiatrist, psychologist, and/or social worker).

Participants will complete self-report evaluation forms at baseline, weekly at CBTm Classes 1 to 5, post-intervention at 6 weeks, and follow-up at 3 months. They will be asked to complete the following measures: (1) Modified DSM-5 Self-Rated Level 1 Cross-Cutting Measure - Adult, (2) Generalized Anxiety Disorder 7-item, (3) Patient Health Questionnaire 9-item (PHQ-9), (4) Session Evaluation questionnaire, (5) Homework Evaluation Form, (6) Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5) with Life Events Checklist (LEC-5) and Criterion A, (7) Connor-Davidson Resilience Scale 10 item (CD-RISC 10), (8) Client Satisfaction Questionnaire (CSQ-8), (9) Short Form-12 (SF-12), (10) Drop out Form, (11) Five Facet Mindfulness Questionnaire 15-Item (FFMQ-15), (12) Perceived Stress Scale, (13) Utrecht Work Engagement Scale 9-Item (UWES-9), and (14) Service Utilization Follow Up.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Employed and on active duty as a police officer, firefighter, paramedic, dispatcher, or corrections officer
3. Employed in Manitoba

Exclusion Criteria:

1. Diagnosed by a psychologist or psychiatrist with a mental health disorder in the past 6 months
2. A history of mental health service use related to a mental disorder in the past 6 months
3. PCL-5 score ≥37
4. PHQ-9 score ≥10
5. GAD-7 score ≥10
6. Suicidal ideation in the past 6 months

Primary outcomes:
measure: Changes in PTSD Symptoms
timeFrame: To be completed at Baseline, at CBTm Classes at week 1,2,3,4,5, post-intervention at 6 weeks, and follow-up at 3 months.
measure: Changes in Anxiety Symptoms
timeFrame: To be completed at Baseline, at CBTm Classes at week 1,2,3,4,5, post-intervention at 6 weeks, and follow-up at 3 months.
measure: Changes in Depressive Symptoms
timeFrame: To be completed at Baseline, at CBTm Classes at week 1,2,3,4,5, post-intervention at 6 weeks, and follow-up at 3 months.
measure: Changes in Resilience Level.
timeFrame: To be completed at Baseline, at CBTm Classes at week 1,2,3,4,5, post-intervention at 6 weeks, and follow-up at 3 months.
Secondary outcomes:
measure: Changes in Physiological and Mental Health Symptoms
timeFrame: To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.
measure: Changes in Perceived Stress Levels
timeFrame: To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.
measure: Evaluation of Client Satisfaction
timeFrame: To be completed at the 5th CBTm Class at Week 5 of the intervention.
measure: Changes in the ability to engage in Mindfulness
timeFrame: To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.
measure: Changes in Work Engagement
timeFrame: To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.
measure: Service Utilization Follow Up
timeFrame: To be completed at the 3 month follow-up.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba Department of Psychiatry
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Shay-Lee Bolton, PhD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Dov Millstone, MPH
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Jitender Sareen, MD
role: PRINCIPAL_INVESTIGATOR
References: