Clinical trial NCT05121194: Evaluation of Virtual CBTm for Public Safety Personnel
Official title: Adaptation and Evaluation of Virtual Group-Based Cognitive Behavior Therapy Classes for Mental Wellness in Public Safety Personnel
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Behaviour Therapy
Keywords: Mental Health
Telemedicine
Public Safety Personnel
Resiliency
Cognitive Behaviour Therapy
Evaluation
Intervention
Prevention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The study will be a nonblinded three-arm randomized controlled trial evaluating the effectiveness of a 5-session CBTm program. Arm 1 will be a videoconference-based, facilitator-led, group CBTm course (ZOOM); Arm 2 will be a self-guided online web-based CBTm course (WEB); and Arm 3 will be a waitlist control group (WAIT).

The investigators initially developed a 4-session (90 min each) facilitator-led CBTm program. As part of their initial pilot work with this population, they created a Project Advisory Committee (PAC), formed of researchers and PSP stakeholders and leaders. Based on their discussions with the PAC, it was recommended that a fifth class be added that focused on responding to traumatic events and stress using a CBT approach along with safety planning for managing crisis situations. As such, the program was adapted to a 5-session model for use in PSP. Session topics are as follows:

Session 1. Mindfulness, Basics of Cognitive Therapy, Thought Records Session 2. Mindfulness, Basics of Behaviour Therapy, Exposure Therapy Session 3. Mindfulness, Healthy Activity, Sleep Hygiene Session 4. Mindfulness, Goal Setting, Assertiveness Session 5. Mindfulness, Dealing with Stress and Stressful Experiences, Wellness Planning

For the proposed study, Arm 1 (ZOOM) participants will be offered the opportunity to join one of 2-3 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 time slot. These meeting times will be arranged based on discussions with the PAC around optimal time slots 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. Arm 2 (WEB) participants will receive access to the online self-guided CBTm course. The material within that program is identical to the material taught within the facilitator-led groups. Participants will receive access to the Session 1 material upon joining the study at which point they will be able to move through the material at their own pace. The material is presented in a slide show format with pre-recorded audio to accompany each slide, in accordance with the material that they would cover if the class was held in-person. Material may be completed in a single sitting or the participant can choose to pause the session and return to it at a later time. Homework will be assigned as in the ZOOM arm through online forms that appear at the end of each session. These forms will be able to be completed online at any point during or after the session. Handouts will be able to be printed if the participant would like to complete the homework on paper. If the participant has any questions, they will have access to a 'contact us' button which will allow questions to be sent to the research team. These emails will be accessed daily by the research team. Some questions may need to be forwarded on to facilitators or clinicians depending on the content. One week after completion of Session 1, participants will receive access to Session 2. This one-week timeframe prior to accessing the next session is used to mirror most closely the time in which participants in the facilitator-led groups will have to practice the skills learned each week before another class is held. The online CBTm course has been in development through Safeandcertified.com, a company with substantial experience in developing and delivering courses for workplace safety and the SafeWork initiative in Manitoba. Arm 3 (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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in 10-item Connor-Davidson Resilience Scale
timeFrame: 5 weeks (change from baseline to end of treatment)
Secondary outcomes:
measure: Change in 10-item Connor-Davidson Resilience Scale
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
measure: Change in Short Form 12 (SF-12)
timeFrame: 5 weeks (change from baseline to end of treatment)
measure: Change in Short Form 12 (SF-12)
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
measure: Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
timeFrame: 5 weeks (change from baseline to end of treatment)
measure: Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
measure: Change in Patient Health Questionnaire 9-Item (PHQ-9)
timeFrame: 5 weeks (change from baseline to end of treatment)
measure: Change in Patient Health Questionnaire 9-Item (PHQ-9)
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
measure: Change in Generalized Anxiety Disorder 7-Item (GAD-7)
timeFrame: 5 weeks (change from baseline to end of treatment)
measure: Change in Generalized Anxiety Disorder 7-Item (GAD-7)
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
measure: Change in Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 5 weeks (change from baseline to end of treatment)
measure: Change in Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
measure: Change in Cannabis Use Disorders Identification Test (CUDIT-R)
timeFrame: 5 weeks (change from baseline to end of treatment)
measure: Change in Cannabis Use Disorders Identification Test (CUDIT-R)
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
measure: Change in Five-Facet Mindfulness Questionnaire (FFMQ-15)
timeFrame: 5 weeks (change from baseline to end of treatment)
measure: Change in Five-Facet Mindfulness Questionnaire (FFMQ-15)
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
measure: Change in The Posttraumatic Stress Disorder Checklist DSM-5 (PCL-5)
timeFrame: 5 weeks (change from baseline to end of treatment)
measure: Change in The Posttraumatic Stress Disorder Checklist DSM-5 (PCL-5)
timeFrame: 6 months (change from end of treatment to 6-month follow-up)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Shay-Lee Bolton, PhD
role: PRINCIPAL_INVESTIGATOR
References: