Creating Resilient Workplaces Study

NCT04002050 | Completed

• 1 other identifier: 2019:165
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Anxiety Disorders; Depression; Stress Disorders, Posttraumatic

Keywords

Resilience; Workplace Engagement; Public Safety Personnel; Stress Disorders

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (6)

• Changes in Physiological and Mental Health Symptoms

  To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.

• Changes in Perceived Stress Levels

  To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.

• Evaluation of Client Satisfaction

  To be completed at the 5th CBTm Class at Week 5 of the intervention.

• Changes in the ability to engage in Mindfulness

  To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.

• Changes in Work Engagement

  To be completed at Baseline, CBTm Class in week 3, post-intervention at week 6, and follow-up at 3 months.

Study Arms (2)

CBTm Course Intervention

ACTIVE COMPARATOR

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

Comparison Group

NO INTERVENTION

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.

Interventions

Cognitive Behavioural Therapy with Mindfulness Course BEHAVIORAL

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).

CBTm Course Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba Department of Psychiatry

Winnipeg, Manitoba, R3E 3N4, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression; Stress Disorders, Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shay-Lee Bolton, PhD

  University of Manitoba

  STUDY DIRECTOR

• Dov Millstone, MPH

  University of Manitoba

  STUDY DIRECTOR

• Jitender Sareen, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 28, 2019
• Study Start: August 10, 2019
• Primary Completion: September 30, 2019
• Study Completion: January 29, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)