Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Creating Resilient Workplaces Study (CReW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002050
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Jitender Sareen, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
PTSD Anxiety Disorders Depression Stress Disorders, Posttraumatic Behavioral: Cognitive Behavioural Therapy with Mindfulness Course Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Cognitive Behaviour Therapy With Mindfulness Course for Building Workplace Resilience: A Pilot Randomized Controlled Trial
Actual Study Start Date : August 10, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: CBTm Course Intervention
Participants placed in the intervention group will receive the CBTm Course. The CBTm Course consists of 5 classes, 90 minutes each, and held in-person on a weekly basis.
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).

No Intervention: Comparison Group
Participants in the comparison group will not receive the intervention during the study, but will be offered intervention once the study has been completed (i.e. 3 month waiting-period). However, in the event that a stressful situation arises while a participant is placed in the comparison group, the participant may seek assistance from the usual mental health supports offered through their respective occupational organizations, EAP programs, and other programs in the community. Following completion of the study, participants in the comparison group will be invited to attend the CBTm Course.



Primary Outcome Measures :
  1. Changes in PTSD Symptoms [ Time Frame: 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. ]
    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.

  2. Changes in Anxiety Symptoms [ Time Frame: 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. ]
    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.

  3. Changes in Depressive Symptoms [ Time Frame: 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. ]
    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.

  4. Changes in Resilience Level. [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Changes in Physiological and Mental Health Symptoms [ Time Frame: To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months. ]
    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.

  2. Changes in Perceived Stress Levels [ Time Frame: To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months. ]
    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).

  3. Evaluation of Client Satisfaction [ Time Frame: To be completed at the 5th CBTm Class at Week 5 of the intervention. ]
    To examine client satisfaction of the CBTm Course as measured by the Client Satisfaction Questionnaire. Higher total scores indicate greater satisfaction.

  4. Changes in the ability to engage in Mindfulness [ Time Frame: To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months. ]
    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.

  5. Changes in Work Engagement [ Time Frame: To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months. ]
    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.

  6. Service Utilization Follow Up [ Time Frame: To be completed at the 3 month 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 or older
  2. Employed and on active duty as a police officer, firefighter, or paramedic
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002050


Contacts
Layout table for location contacts
Contact: Jacquelyne Wong, MA 204-787-7729 jwong8@hsc.mb.ca
Contact: Jitender Sareen, MD 204-294-7344 Jitender.Sareen@umanitoba.ca

Locations
Layout table for location information
Canada, Manitoba
University of Manitoba Department of Psychiatry Recruiting
Winnipeg, Manitoba, Canada, R3E 3N4
Contact: Jacquelyne Wong, MA    204-787-7729    jwong8@hsc.mb.ca   
Contact: Jitender Sareen, MD    204-787-7056    jitender.sareen@umanitoba.ca   
Principal Investigator: Jacquelyne Wong, MA         
Sub-Investigator: Jitender Sareen, MD         
Sub-Investigator: Tanya Sala, MD         
Sub-Investigator: Debbie Whitney, PhD         
Sub-Investigator: Natalie Mota, PhD         
Sub-Investigator: Pam Holens, PhD         
Sub-Investigator: Sarvesh Logsetty, MD         
Sub-Investigator: Joshua Aquin, MD         
Sub-Investigator: Laurence Katz, MD         
Sub-Investigator: Nicholas Carleton, PhD         
Sub-Investigator: Gordon Asmundson, PhD         
Sub-Investigator: Heather Hadjistavropoulos, PhD         
Sub-Investigator: Jolene Kinley, PhD         
Sub-Investigator: Shay-Lee Bolton, PhD         
Sponsors and Collaborators
University of Manitoba
Investigators
Layout table for investigator information
Principal Investigator: Jacquelyne Wong, MA University of Manitoba
Layout table for additonal information
Responsible Party: Dr. Jitender Sareen, Professor of Psychiatry, University of Manitoba
ClinicalTrials.gov Identifier: NCT04002050    
Other Study ID Numbers: 2019:165
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Jitender Sareen, University of Manitoba:
Resilience
Workplace Engagement
Public Safety Personnel
Stress Disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Stress Disorders, Traumatic
Anxiety Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders