Creating Resilient Workplaces Study

Depression Clinical Trial

— CReW  

Official title:

Cognitive Behaviour Therapy With Mindfulness Course for Building Workplace Resilience: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002050
• Other study ID #: 2019:165
• Status: Completed
• Phase: N/A
• Start date: August 10, 2019
• Est. completion date: January 29, 2021

Study information

• Verified date: April 2022
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 29, 2021
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Disease
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Posttraumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Behavioural Therapy with Mindfulness Course
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).

Locations

Country	Name	City	State
Canada	University of Manitoba Department of Psychiatry	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in PTSD Symptoms	To examine the impact of the CBTm Course on symptoms of PTSD as measured by the Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5). A 10% change in score on this measurement tool is considered clinically significant.	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.
Primary	Changes in Anxiety Symptoms	To examine the impact of the CBTm course on symptoms of anxiety as measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7). This questionnaire objectively determines initial symptom severity and monitors symptom changes/effect of treatment over time. Each item is scored on a scale of "0" (not at all) to "3" (nearly every day). Scores of 5, 10, and 15 are used as the cut-off points for mild, moderate and severe anxiety, respectively.	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.
Primary	Changes in Depressive Symptoms	To examine the impact of the CBTm course on symptoms of depression as measured by the Patient Health Questionnaire 9-item (PHQ-9). This questionnaire objectively determines initial symptom severity and monitors symptom changes/effect of treatment over time. Each item is scored on a scale of "0" (not at all) to "3" (nearly every day). Scores of 5, 10, and 15 are used as the cut-off points for mild, moderate and severe depression, respectively.	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.
Primary	Changes in Resilience Level.	To examine the impact of the CBTm Course on resilience as measured by the Connor-Davidson Resilience Scale 10 (CD-RISC10). This questionnaire is used to rate an individual's resilience on a scale of 1 - 40 with a higher score reflecting a higher level of self-identified resilience.	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	Changes in Physiological and Mental Health Symptoms	To examine the impact of the CBTm Course on physiological and mental health symptoms as measured by the Short Form 12 (SF-12). The total score is compared to the mean scores of the general population to give ratings of above average, average and below average.	To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.
Secondary	Changes in Perceived Stress Levels	To examine the impact of the CBTm Course on perceived levels of stress as measured by the Perceived Stress Scale. This scale classifies perceived stress levels into low (scores of 0-13), moderate (score of 14-26) and high stress (score of 27- 40).	To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.
Secondary	Evaluation of Client Satisfaction	To examine client satisfaction of the CBTm Course as measured by the Client Satisfaction Questionnaire. Higher total scores indicate greater satisfaction.	To be completed at the 5th CBTm Class at Week 5 of the intervention.
Secondary	Changes in the ability to engage in Mindfulness	To examine the impact of the CBTm Course on one's ability to engage in mindfulness as measured by the 15-Item Five Facet Mindfulness Questionnaire. The five areas of mindfulness measured are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Higher total/sub-scale scores indicate increased engagement in mindfulness.	To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.
Secondary	Changes in Work Engagement	To examine the impact of the CBTm Course on work engagement as measured by the 9-Item Utrecht Work Engagement Scale. The measure is scored over three dimensions: vigor, dedication, and absorption. Higher total scores are negative correlates of burnout.	To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.
Secondary	Service Utilization Follow Up	To determine whether any participants received service or treatment for emotional, alcohol or drug problems while enrolled in the study, which are confounding variables that may potentially affect the study's results	To be completed at the 3 month follow-up.