Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666974
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2020-12-05
Brief Title:
Delivering ICBT to Address Mental Health Challenges in Correctional Officers and Other Public Safety Personnel
Sponsor:
Dr Nazanin Alavi
Organization:
Queens University
Study Overview
Official Title:
Delivering Online Cognitive Behavioural Therapy iCBT to Address Mental Health Challenges in Correctional Officers and Other Public Safety Personnel
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Public safety personnel PSP have regular and often intense exposure to potentially traumatic events at work and are at higher risk for developing mental health problems such as posttraumatic stress disorder PTSD Studies have shown up to 4 times higher suicidal ideation attempt and death among this population compared to the general population Despite the high rate of mental health problems among PSPs their willingness to receive mental healthcare support is fairly low mainly due to the stigma attached to these disorders Those who are willing to seek help face unique barriers including their irregular shift hours limiting their access to resources otherwise available to the public Given these challenges and the critical contribution of PSPs to public safety developing innovative solutions to address their mental health must be a healthcare priority
This proposal aims to study the efficacy of using an innovative approach in delivering mental health online to address mental health problems among correctional workers CW who are especially prone to mental health problems given the high rate of workplace violence It is hypothesized that using an online platform to deliver cognitive behavioural therapy CBT would lower the stigma of receiving care in a secure and confidential environment easing CWs concerns about stigma from co-workers The content is delivered through interactive and engaging therapy modules designed for specific groups of CWs and customized by situational examples to make therapy more relatable These online modules would provide CWs with 247 access to therapy content solving the irregular work hour problem The online CBT modules developed in this study would provide high quality and clinically validated resources to address mental health problems of CWs all across Canada Knowledge acquired through this project could also be beneficial to using iCBT in general for addressing mental health challenges among other PSPs
This proposal aims to study the efficacy of using an innovative approach in delivering mental health online to address mental health problems among correctional workers CW who are especially prone to mental health problems given the high rate of workplace violence It is hypothesized that using an online platform to deliver cognitive behavioural therapy CBT would lower the stigma of receiving care in a secure and confidential environment easing CWs concerns about stigma from co-workers The content is delivered through interactive and engaging therapy modules designed for specific groups of CWs and customized by situational examples to make therapy more relatable These online modules would provide CWs with 247 access to therapy content solving the irregular work hour problem The online CBT modules developed in this study would provide high quality and clinically validated resources to address mental health problems of CWs all across Canada Knowledge acquired through this project could also be beneficial to using iCBT in general for addressing mental health challenges among other PSPs
Detailed Description:
Phase 1 An expert end-user group of correctional workers n 5 will help the research team across all phases of this project These experts will have in-depth knowledge of CW problems and will be chosen in consultation with CW union members Provincial correctional workers n 40 20 male 20 female will be recruited to participate in individual interviews and then in virtual focus groups through Microsoft Teams These interviews will be used to identify the main mental health challenges and the best methods to address them in the context of different groups of CWs administrative operational workers direct vs indirect contact with prisoners working in a prison vs working in probation offices etc and investigate the barriers specific to each group Interviewfocus group members will be recruited through flyers distributed in place of work advertisements in specialized journals through union representatives and through word of mouth Each individual will be independently interviewed by a trained research assistant RA hired for the project 60-90-minute interviews Interviews will occur remotely via a secure video conference with Microsoft Teams Questions will include topics of the level of interaction with prisoners types and frequency of violence at work sexual assault work condition staffing shift length relationship with superiors and co-workers work-load over-crowdedness socio-economic factors racial gender language sexuality religious discrimination mental challenges anxiety depression PTSD suicidal ideation resources training peer-support and professional help and frequency they use them reasons for refraining to use resources the preferred method of support onsite vs offsite individual vs group and attitude towards online care willing to do so and what content they want to be covered Information gathered through individual interviews will form the basis for further virtual focus group discussions with Microsoft Teams The final format of the questionnaire will be decided in consultation between the PI and all co-applicants including experts of the field Drs Simpson Gerritsen and Martin and the expert end-user group to ensure the validity of each question from psychiatric epidemiologic psychologic forensic and professional aspects
Following individual interviews 5 half-day focus groups 8 participants per group 2 exclusively female 2 exclusively male 1 evenly mixed will be conducted to gather more information regarding issues uncovered in individual interviews These focus groups will occur remotely via a virtual video conference with Microsoft Teams A list of challenges to be addressed in phases 2-4 will be formed from these interviews The PI one psychiatrist one psychologist one RA and at least 2 members of the end-user expert group will attend each group meeting to form a better understanding of the problems faced by each group All interviews and focus group discussions will be recorded and transcribed verbatim for further discussion at the investigative team meetings
Phase 2 Following the first round of content development each CBT module will be presented to the end-user expert group and a smaller number of interviewfocus group participants 10 males 10 females for feedback Each participant will be asked to provide feedback on one of the six therapeutic modules regarding content form presentation examples and helpfulness based on the challenges it tries to address All feedback will be summarized and compiled by project RAs and discussed in 6 separate focus group discussions attended by the PI one psychiatrist one psychologist one RA and at least 2 members of the end-user expert group Each participant is requested to attend two virtual focus group discussions on the module they have not seen yet or commented on This step is done to ensure each participant can provide feedback on all gender-specific therapy contents A list of recommended changes to each module is developed through these group discussions Recommendations will be reviewed by the PI co-applicants and the knowledge users for clinical validation The final changes compiled by clinicians will be applied to each module and proper graphical changes will be made
Phase 3 CW participants will be recruited for this phase of the study through flyers distributed in place of work advertisements in specialized journals through union representatives and through word of mouth Also in this phase the investigators will accept participants based on referrals from family physicians or psychiatrists in small cities with correctional facilities who could be easily informed of the study through academic recourses All CWs will go through a comprehensive initial mental health assessment by a psychiatrist either in person or through video using Ontario Telemedicine Network OTN All diagnoses are validated by a structured Mini-International Neuropsychiatric Interview MINI performed by a trained RA To be included for the study the CW should be between 18-55 years of age at the start of the study diagnosed with either major depressive disorder MDD generalized anxiety disorder GAD or post-traumatic stress disorder PTSD according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition DSM-5 by a psychiatrist on the team competence to provide informed consent and participate able to speak and read English and consistent and reliable access to the internet The CWs are excluded from the study if they are diagnosed with hypomanicmanic episodes psychosis severe alcohol or substance use disorder and active suicidal or homicidal ideation
The 100 CWs 50 males 50 females meeting the inclusionexclusion criteria will complete a set of socioeconomic and demographic questionnaires and baseline quantitative clinical questionnaires delivered online through the Online Psychotherapy Tool OPTT DASS42 Q-LES-Q QIDS-SR16 PHQ-9 GAD7 PCL-5 OPTT is a secure cloud-based online platform After the initial assessment the CWs will be randomly assigned to one of two study arms 50 CWs receiving iCBT TAU treatment vs 50 CWs receiving TAU control
CWs in the iCBT group will be assigned to one of the six therapy modules based on their gender and diagnosis ie FemaleMale GAD MDD or PTSD Each CW will be assigned a specific clinician a trained psychiatristpsychologist social worker who would be their care liaison through the study Each week the clinician would send one session of the 12-session curriculum to the CW on a pre-determined day of the week Each weekly session consists of 20-30 slides followed by a homework assignment It usually takes 40-60 minutes for a participant to complete one weekly session which they have to complete by a specific day of the week The clinician will review the CWs assignments and provide feedback on their performance The clinician feedback is structured and takes approximately 15 minutes to complete The clinician will then send the content for the next session along with the feedback
CWs in both study arms will be asked to complete biweekly questionnaires depending on diagnosis to evaluate any change in diagnostic symptoms At the end of week 12 the CWs will be asked to complete a final set of questionnaires same as baseline and another MINI In order to evaluate long-term effects follow up evaluations of both study arms will be done at 6 and 12 months following initial enrolment using the same quantitative questionnaires In addition to clinical evaluations CWs receiving iCBT will fill a qualitative questionnaire regarding their experience using OPTT These questions will include -whether OPTT was aesthetically appealing whether OPTT was intuitive if they needed technical support whether the navigation was simple enough devices they used to access their therapy The results of this feasibility survey will be discussed with the end-user expert group and system changes will be made for a better experience for the next phase As data is collected through the experiment anonymized data diagnosis initial and week 12 assessments bi-weekly progress and 6- and 12-month follow-up assessments will be shared with the other co-investigators to use in publications or presentations
Phase 4 CWs will be recruited for the study using the same methods as in phase 3 going through a comprehensive interview by a psychiatrist and validated by a MINI performed by trained RAs Similar inclusionexclusion criteria as in phase 3 are used for this phase as well 100 CWs gender-balanced meeting inclusionexclusion criteria will complete a set of socio-economic and demographic questionnaires and baseline quantitative clinical questionnaires delivered online through OPTT Following the initial assessment the CWs will then be randomly assigned to either iCBT TAU n50 or in-person CBT TAU n50
CWs in either study arm will be will then be assigned to one of the therapy modules based on primary diagnosis and gender FemaleMale GAD MDD or PTSD Each CW will be assigned a specific clinician trained psychiatristpsychologistsocial worker who will be their care liaison through the study The in-person CBT group will receive similar content homework and feedback as in the iCBT group All in-person CBT will be delivered by a trained professional psychiatristpsychologistSW Each appointment is expected to take 60-75 minutes per week
CWs in both study arms will complete biweekly tests depending on diagnosis to evaluate progress At the end of the 12 weeks the CWs will be asked to complete a final set of quantitative questionnaires and to complete another MINI Feasibility questionnaires will be sent to CWs in the iCBT group and the responses will be discussed with the end-user expert group to form recommendations for improving OPTT As data is collected through the study anonymized data diagnosis initial bi-weekly and 12-week assessments will be openly shared for other researchers to use as well
Following individual interviews 5 half-day focus groups 8 participants per group 2 exclusively female 2 exclusively male 1 evenly mixed will be conducted to gather more information regarding issues uncovered in individual interviews These focus groups will occur remotely via a virtual video conference with Microsoft Teams A list of challenges to be addressed in phases 2-4 will be formed from these interviews The PI one psychiatrist one psychologist one RA and at least 2 members of the end-user expert group will attend each group meeting to form a better understanding of the problems faced by each group All interviews and focus group discussions will be recorded and transcribed verbatim for further discussion at the investigative team meetings
Phase 2 Following the first round of content development each CBT module will be presented to the end-user expert group and a smaller number of interviewfocus group participants 10 males 10 females for feedback Each participant will be asked to provide feedback on one of the six therapeutic modules regarding content form presentation examples and helpfulness based on the challenges it tries to address All feedback will be summarized and compiled by project RAs and discussed in 6 separate focus group discussions attended by the PI one psychiatrist one psychologist one RA and at least 2 members of the end-user expert group Each participant is requested to attend two virtual focus group discussions on the module they have not seen yet or commented on This step is done to ensure each participant can provide feedback on all gender-specific therapy contents A list of recommended changes to each module is developed through these group discussions Recommendations will be reviewed by the PI co-applicants and the knowledge users for clinical validation The final changes compiled by clinicians will be applied to each module and proper graphical changes will be made
Phase 3 CW participants will be recruited for this phase of the study through flyers distributed in place of work advertisements in specialized journals through union representatives and through word of mouth Also in this phase the investigators will accept participants based on referrals from family physicians or psychiatrists in small cities with correctional facilities who could be easily informed of the study through academic recourses All CWs will go through a comprehensive initial mental health assessment by a psychiatrist either in person or through video using Ontario Telemedicine Network OTN All diagnoses are validated by a structured Mini-International Neuropsychiatric Interview MINI performed by a trained RA To be included for the study the CW should be between 18-55 years of age at the start of the study diagnosed with either major depressive disorder MDD generalized anxiety disorder GAD or post-traumatic stress disorder PTSD according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition DSM-5 by a psychiatrist on the team competence to provide informed consent and participate able to speak and read English and consistent and reliable access to the internet The CWs are excluded from the study if they are diagnosed with hypomanicmanic episodes psychosis severe alcohol or substance use disorder and active suicidal or homicidal ideation
The 100 CWs 50 males 50 females meeting the inclusionexclusion criteria will complete a set of socioeconomic and demographic questionnaires and baseline quantitative clinical questionnaires delivered online through the Online Psychotherapy Tool OPTT DASS42 Q-LES-Q QIDS-SR16 PHQ-9 GAD7 PCL-5 OPTT is a secure cloud-based online platform After the initial assessment the CWs will be randomly assigned to one of two study arms 50 CWs receiving iCBT TAU treatment vs 50 CWs receiving TAU control
CWs in the iCBT group will be assigned to one of the six therapy modules based on their gender and diagnosis ie FemaleMale GAD MDD or PTSD Each CW will be assigned a specific clinician a trained psychiatristpsychologist social worker who would be their care liaison through the study Each week the clinician would send one session of the 12-session curriculum to the CW on a pre-determined day of the week Each weekly session consists of 20-30 slides followed by a homework assignment It usually takes 40-60 minutes for a participant to complete one weekly session which they have to complete by a specific day of the week The clinician will review the CWs assignments and provide feedback on their performance The clinician feedback is structured and takes approximately 15 minutes to complete The clinician will then send the content for the next session along with the feedback
CWs in both study arms will be asked to complete biweekly questionnaires depending on diagnosis to evaluate any change in diagnostic symptoms At the end of week 12 the CWs will be asked to complete a final set of questionnaires same as baseline and another MINI In order to evaluate long-term effects follow up evaluations of both study arms will be done at 6 and 12 months following initial enrolment using the same quantitative questionnaires In addition to clinical evaluations CWs receiving iCBT will fill a qualitative questionnaire regarding their experience using OPTT These questions will include -whether OPTT was aesthetically appealing whether OPTT was intuitive if they needed technical support whether the navigation was simple enough devices they used to access their therapy The results of this feasibility survey will be discussed with the end-user expert group and system changes will be made for a better experience for the next phase As data is collected through the experiment anonymized data diagnosis initial and week 12 assessments bi-weekly progress and 6- and 12-month follow-up assessments will be shared with the other co-investigators to use in publications or presentations
Phase 4 CWs will be recruited for the study using the same methods as in phase 3 going through a comprehensive interview by a psychiatrist and validated by a MINI performed by trained RAs Similar inclusionexclusion criteria as in phase 3 are used for this phase as well 100 CWs gender-balanced meeting inclusionexclusion criteria will complete a set of socio-economic and demographic questionnaires and baseline quantitative clinical questionnaires delivered online through OPTT Following the initial assessment the CWs will then be randomly assigned to either iCBT TAU n50 or in-person CBT TAU n50
CWs in either study arm will be will then be assigned to one of the therapy modules based on primary diagnosis and gender FemaleMale GAD MDD or PTSD Each CW will be assigned a specific clinician trained psychiatristpsychologistsocial worker who will be their care liaison through the study The in-person CBT group will receive similar content homework and feedback as in the iCBT group All in-person CBT will be delivered by a trained professional psychiatristpsychologistSW Each appointment is expected to take 60-75 minutes per week
CWs in both study arms will complete biweekly tests depending on diagnosis to evaluate progress At the end of the 12 weeks the CWs will be asked to complete a final set of quantitative questionnaires and to complete another MINI Feasibility questionnaires will be sent to CWs in the iCBT group and the responses will be discussed with the end-user expert group to form recommendations for improving OPTT As data is collected through the study anonymized data diagnosis initial bi-weekly and 12-week assessments will be openly shared for other researchers to use as well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None