Cognitive Behaviour TherapyNCT05121194
Evaluation of Virtual CBTm for Public Safety Personnel
A study testing Cognitive Behaviour Therapy in people with Cognitive Behaviour Therapy, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Behaviour Therapy
- What is being tested?
- Cognitive Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Evaluation of Virtual Group-Based Cognitive Behavior Therapy Classes for Mental Wellness in Public Safety Personnel
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?
Read more
Secondary Objectives:
- 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.
Read the 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).
- Conditions
- Cognitive Behaviour Therapy
- Being tested
- Cognitive Behaviour Therapy
- Keywords
- Mental Health, Telemedicine, Public Safety Personnel, Resiliency, Cognitive Behaviour Therapy, Evaluation, Intervention, Prevention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 weeks (change from baseline to end of treatment)
Secondary outcomes (17)
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)
Measured: 6 months (change from end of treatment to 6-month follow-up)
Change in Short Form 12 (SF-12)
change in scores
This 12-item version of the original 36-item scale is a self-report of health-related quality of life. The scale includes 2 subscales, the physical component score (PCS-12) and mental component score (MCS-12) Scale Range: 0-100 (standard score for total and each subscale) Lower scores indicate worse physical and mental health functioning (i.e., worse outcome) Higher scores indicate better physical and mental health functioning (i.e., better outcome)
Measured: 5 weeks (change from baseline to end of treatment)
Change in Short Form 12 (SF-12)
change in scores
This 12-item version of the original 36-item scale is a self-report of health-related quality of life. The scale includes 2 subscales, the physical component score (PCS-12) and mental component score (MCS-12) Scale Range: 0-100 (standard score for total and each subscale) Lower scores indicate worse physical and mental health functioning (i.e., worse outcome) Higher scores indicate better physical and mental health functioning (i.e., better outcome)
Measured: 6 months (change from end of treatment to 6-month follow-up)
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
change in scores
Designed specifically for assessing burnout among those working in the human services. The MBI-HSS comprises 22 questions across 3 subscales; Emotional Exhaustion (EE)-9 questions, Depersonalization (DP)-5 questions, and self-perceived lack of Personal Accomplishment (PA)-8 questions.
Scale Range: EE (0-54), DP (0-30), PA (0-48) Lower scores indicate less EE, DP, and PA (i.e., better outcome) Higher scores indicate more EE, DP, and PA (i.e., worse outcome)
Measured: 5 weeks (change from baseline to end of treatment)
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
change in scores
Designed specifically for assessing burnout among those working in the human services. The MBI-HSS comprises 22 questions across 3 subscales; Emotional Exhaustion (EE)-9 questions, Depersonalization (DP)-5 questions, and self-perceived lack of Personal Accomplishment (PA)-8 questions.
Scale Range: EE (0-54), DP (0-30), PA (0-48) Lower scores indicate less EE, DP, and PA (i.e., better outcome) Higher scores indicate more EE, DP, and PA (i.e., worse outcome)
Measured: 6 months (change from end of treatment to 6-month follow-up)
Change in Patient Health Questionnaire 9-Item (PHQ-9)
change in scores
Validated and reliable 9-item measure for assessing the severity of depression in the general population Scale range: 0-27 (total score_ Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: 5 weeks (change from baseline to end of treatment)
Change in Patient Health Questionnaire 9-Item (PHQ-9)
change in scores
Validated and reliable 9-item measure for assessing the severity of depression in the general population Scale range: 0-27 (total score_ Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: 6 months (change from end of treatment to 6-month follow-up)
Change in Generalized Anxiety Disorder 7-Item (GAD-7)
change in scores
This 7-item measure assesses anxiety in the general population Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)
Measured: 5 weeks (change from baseline to end of treatment)
Change in Generalized Anxiety Disorder 7-Item (GAD-7)
change in scores
This 7-item measure assesses anxiety in the general population Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)
Measured: 6 months (change from end of treatment to 6-month follow-up)
Change in Alcohol Use Disorders Identification Test (AUDIT)
change in scores
This 10-item screening tool is used to assess alcohol consumption, drinking behaviors, and alcohol-related problems Scale range: (0-40) A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
Measured: 5 weeks (change from baseline to end of treatment)
Change in Alcohol Use Disorders Identification Test (AUDIT)
change in scores
This 10-item screening tool is used to assess alcohol consumption, drinking behaviors, and alcohol-related problems Scale range: (0-40) A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
Measured: 6 months (change from end of treatment to 6-month follow-up)
Change in Cannabis Use Disorders Identification Test (CUDIT-R)
change in scores
This 8-item screening tool was developed to assess possible cannabis use issues.
Scale range: (0-32) Scores of 8 or more indicate hazardous cannabis use, while scores of 12 or more indicate a possible cannabis use disorder for which further intervention may be required.
Measured: 5 weeks (change from baseline to end of treatment)
Change in Cannabis Use Disorders Identification Test (CUDIT-R)
change in scores
This 8-item screening tool was developed to assess possible cannabis use issues.
Scale range: (0-32) Scores of 8 or more indicate hazardous cannabis use, while scores of 12 or more indicate a possible cannabis use disorder for which further intervention may be required.
Measured: 6 months (change from end of treatment to 6-month follow-up)
Change in Five-Facet Mindfulness Questionnaire (FFMQ-15)
change in scores
This 15-item scale is used to assess level of mindfulness (observing, describing, etc).
Scale range: (0-75) Lower scores indicate lower level of mindfulness (i.e., worse outcome) Higher scores indicate higher level of mindfulness (i.e., better outcome)
Measured: 5 weeks (change from baseline to end of treatment)
Change in Five-Facet Mindfulness Questionnaire (FFMQ-15)
change in scores
This 15-item scale is used to assess level of mindfulness (observing, describing, etc).
Scale range: (0-75) Lower scores indicate lower level of mindfulness (i.e., worse outcome) Higher scores indicate higher level of mindfulness (i.e., better outcome)
Measured: 6 months (change from end of treatment to 6-month follow-up)
Change in The Posttraumatic Stress Disorder Checklist DSM-5 (PCL-5)
change in scores
This questionnaire is a 20-item self-report measure of posttraumatic stress disorder Scale range: 0-80 (total score) Lower scores indicate lower severity of PTSD symptoms (i.e., better outcome) Higher scores indicate higher severity of PTSD symptoms (i.e., worse outcome)
Measured: 5 weeks (change from baseline to end of treatment)
Change in The Posttraumatic Stress Disorder Checklist DSM-5 (PCL-5)
change in scores
This questionnaire is a 20-item self-report measure of posttraumatic stress disorder Scale range: 0-80 (total score) Lower scores indicate lower severity of PTSD symptoms (i.e., better outcome) Higher scores indicate higher severity of PTSD symptoms (i.e., worse outcome)
Measured: 6 months (change from end of treatment to 6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start15 Jan 2022
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behaviour TherapyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shay-Lee Bolton, University of Manitoba
- Investigators
- Shay-Lee Bolton, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121194
- Sponsor's protocol ID
- H2021:196
- Other IDs
- PJI-175442
- Status last verified
- May 2024
- First submitted
- 15 Sep 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Evaluation of Virtual Group-Based Cognitive Behavior Therapy Classes for Mental Wellness in Public Safety Personnel
- ClinicalTrials.gov ID
- NCT05121194
- Acronym / sponsor ID
- H2021:196
- Conditions
- Cognitive Behaviour Therapy
- Keywords
- Mental Health, Telemedicine, Public Safety Personnel, Resiliency, Cognitive Behaviour Therapy, Evaluation, Intervention, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZOOM Video Conference Participants | Active comparator | Behavioral: Cognitive Behaviour TherapyParticipants 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. |
| WEB Online CBTm Course Participants | Active comparator | Behavioral: Cognitive Behaviour TherapyParticipants 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) |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behaviour TherapyGroup-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. | Behavioural | WEB Online CBTm Course Participants, ZOOM Video Conference Participants |
Primary outcome
Change in 10-item Connor-Davidson Resilience Scale
Time frame: 5 weeks (change from baseline to end of treatment)
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)
17 secondary outcomes
Change in 10-item Connor-Davidson Resilience Scale
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Change in Short Form 12 (SF-12)
Time frame: 5 weeks (change from baseline to end of treatment)
Change in Short Form 12 (SF-12)
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
Time frame: 5 weeks (change from baseline to end of treatment)
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Change in Patient Health Questionnaire 9-Item (PHQ-9)
Time frame: 5 weeks (change from baseline to end of treatment)
Change in Patient Health Questionnaire 9-Item (PHQ-9)
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Change in Generalized Anxiety Disorder 7-Item (GAD-7)
Time frame: 5 weeks (change from baseline to end of treatment)
Change in Generalized Anxiety Disorder 7-Item (GAD-7)
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Change in Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 5 weeks (change from baseline to end of treatment)
Change in Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Change in Cannabis Use Disorders Identification Test (CUDIT-R)
Time frame: 5 weeks (change from baseline to end of treatment)
Change in Cannabis Use Disorders Identification Test (CUDIT-R)
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Change in Five-Facet Mindfulness Questionnaire (FFMQ-15)
Time frame: 5 weeks (change from baseline to end of treatment)
Change in Five-Facet Mindfulness Questionnaire (FFMQ-15)
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Change in The Posttraumatic Stress Disorder Checklist DSM-5 (PCL-5)
Time frame: 5 weeks (change from baseline to end of treatment)
Change in The Posttraumatic Stress Disorder Checklist DSM-5 (PCL-5)
Time frame: 6 months (change from end of treatment to 6-month follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shay-Lee Bolton, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behaviour Therapy in people with Cognitive Behaviour Therapy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10-item Connor-Davidson Resilience Scale (time frame: 5 weeks (change from baseline to end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.