Evaluation of Virtual CBTm for Public Safety Personnel

NCT05121194 | Active Not Recruiting

• 2 other identifiers: H2021:196PJI-175442
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The principal aim of this study is to evaluate whether virtual CBTm is effective in improving mental wellness among public safety personnel (PSP). The investigators have adapted the CBTm classes to two virtual formats: 1) a facilitator-led set of virtual CBTm classes, and 2) an online self-guided version of the program. Primary Objective: Can virtual CBTm increase resiliency among PSP? Secondary Objectives: i. Does virtual CBTm improve clinical symptoms of mental and substance use disorders (e.g., depression, anxiety, PTSD, alcohol abuse) among PSP? ii. Does virtual CBTm improve self-perceived health-related quality of life among PSP? iii. Does virtual CBTm reduce burnout among PSP? Evaluation of all primary and secondary objectives will focus on clinically significant improvement in scores on well-validated measures. Steps to evaluate these objectives will include: 1) Recruit a cohort of PSP; 2) Assess baseline levels of resiliency, mental health symptoms, substance use, level of burnout, and current health-related quality of life; 3) Randomize individuals to one of two intervention arms or a waitlist control group; 4) Deliver CBTm in 2 different virtual formats; 5) Evaluate whether scores over time are significantly improved among individuals in each of the virtual CBTm groups compared with the waitlist control group. Comparisons of similarities and differences between the two intervention arms will also be conducted, particularly in terms of feasibility, acceptability, and facilitators/barriers of the virtual format for participants. The investigators will identify the demographic/symptom profiles of those who benefit most from each virtual-based CBTm.

Conditions

Cognitive Behaviour Therapy

Keywords

Mental Health; Telemedicine; Public Safety Personnel; Resiliency; Cognitive Behaviour Therapy; Evaluation; Intervention; Prevention

Outcome Measures

Primary Outcomes (1)

• Change in 10-item Connor-Davidson Resilience Scale

  changes in scores This 10-item version of the original 25-item scale was developed to measure resiliency. Scale Range: 0-40 (total score) Lower scores indicate less resiliency (i.e., worse outcome) Higher scores indicate more resiliency (i.e., better outcome)

  5 weeks (change from baseline to end of treatment)

Secondary Outcomes (17)

• Change in 10-item Connor-Davidson Resilience Scale

  6 months (change from end of treatment to 6-month follow-up)

• Change in Short Form 12 (SF-12)

  5 weeks (change from baseline to end of treatment)

• Change in Short Form 12 (SF-12)

  6 months (change from end of treatment to 6-month follow-up)

• Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)

  5 weeks (change from baseline to end of treatment)

• Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)

  6 months (change from end of treatment to 6-month follow-up)

Study Arms (3)

ZOOM Video Conference Participants

ACTIVE COMPARATOR

Participants will be offered the opportunity to join one of two weekly meeting times. Participants will be sent a link to join a Zoom videoconference session at the outset of each week, allowing them to log in at their chosen timeslot. These meeting times will be arranged based on discussions with the PAC around optimal timeslots for their shift workers. Sessions will be 90 minutes in length and will be facilitated by a minimum of 2 trained clinician facilitators and 1 research assistant. The session will include a PowerPoint presentation of the CBTm material in a lecture format. Participants will be invited and encouraged to discuss, comment and ask questions of the facilitators about the material throughout the presentation. Homework will be assigned each session relating to the material that was covered. Participants will have 1 week to work through and practice the skills learned, and this homework will be discussed at the next session.

Behavioral: Cognitive Behaviour Therapy

WEB Online CBTm Course Participants

ACTIVE COMPARATOR

Participants will receive access to the online self-guided CBTm course. The material is identical to the material taught in the facilitator-led group. Participants will receive access to the Class 1 upon joining the study at which point they can move through the material. The material is presented in a slide show format with pre-recorded audio to accompany each slide, in accordance with the material covered for in person classes. Material may be completed in a single sitting or they can choose to pause and return to it at a later time. Homework will be assigned as in Arm 1, through online forms at the end of each class. If a participant has questions, they can use a 'contact us' button, allowing questions to be sent to our research team. One week after completion of Class 1, participants will receive access to Class 2. The one-week timeframe prior to accessing the next class is used to mirror the timeline in the facilitator-led groups (Arm 1)

Behavioral: Cognitive Behaviour Therapy

WAIT participants

NO INTERVENTION

(WAIT) participants will be assigned to a waitlist control. These individuals will not receive any type of active intervention but will continue to receive mental health questionnaires to complete in line with the ZOOM and WEB participants at weekly intervals. These individuals will be offered a choice of videoconference CBTm or online CBTm at completion of their waitlist period (6 months).

Interventions

Cognitive Behaviour Therapy BEHAVIORAL

Group-based cognitive behaviour therapy (CBT) is an evidence-based treatment that allows service providers to interact with high volumes of individuals who need mental health support. CBT is the most well-researched and well-recognized of all psychotherapies, and is often considered the gold-standard in psychotherapy treatment. While CBT has shown efficacy in the treatment of a range of mental and substance use disorders, it has also been shown to be useful in building resiliency, being used as a tool to better cope during stressful life situations even among individuals who do not have an existing mental illness. Furthermore, research suggests that gains achieved in mental health during CBT are maintained long after treatment completion.

WEB Online CBTm Course Participants; ZOOM Video Conference Participants

Eligibility Criteria

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

You may qualify if:

• Individuals must be of legal adult status (age 18 or older)
• currently employed as a public safety worker (e.g., police officer, law enforcement, fire fighter, paramedic, dispatcher, correctional worker),
• and located within Manitoba

You may not qualify if:

• None

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 3N4, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shay-Lee Bolton, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: November 16, 2021
• Study Start: January 15, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)