Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-03
Brief Title:
Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
iCBT-SAD
Brief Summary:
The objectives of the study are to 1 to translate and adapt iCBT Shyness Program to the Canadian context 2 to examine the completion and effectiveness of the Canadian adapted including the French translated and English iCBT Shyness Program in improving SAD symptoms 3 to explore barriers and facilitating factors to the programs implementation The overall study design is a hybrid effectiveness-implementation study of a quasi-experimental parallel group trial reflecting real world pathways recommended and self-referrals The project will be conducted in two Canadian provinces Quebec Montérégie and Ontario Prior to implementing the iCBT Shyness Program it will undergo an initial adaptation to the Canadian context and focus groups will be conducted with key actor groups to discuss the adaptations to the graphics narration of the modules and this to better reflect varying sociocultural context among Canadian French- and English-speaking populations We will then evaluate the outcomes associated with the implementation of the program in a three-pathway parallel trial As a last step to this trial semi-structured interviews will be conducted with study participants and health care providers to explore facilitating factors and barriers to the implementation of the iCBT adapted program
Detailed Description:
Study rational Social anxiety disorder SAD is one of the most prevalent anxiety disorders with lifetime and past-year prevalence estimates reaching 12 and 7 in Canada In the absence of treatment SAD is a chronic disorder with significant impairment in functioning associated with reduced school performance loss of productivity and decreased quality of life During COVID-19 studies highlight increased mental health needs but barriers to mental health service access due inpart to limited resources available Viable therapy options for the treatment of SAD include CBT being delivered virtually with effectiveness being shown in youth and adults The Clinical Research Unit for Anxiety and Depression CRUfAD in Australia has developed implemented and demonstrated the effectiveness of an innovative guided and unguided internet delivered cognitive-behavioural therapy iCBT program for social anxiety To make available high-quality and real-time evidence in response to the current COVID-19 mental health crisis and crucially needed access to psychological services to meet population mental health needs including for high risk populations including individuals with pre-existing psychiatric conditions youth and young adults self identifying as belonging to a visible minority group including from linguistic minority groups we propose to conduct a Canadian adaptation of Australias Shyness Program and to examine the adapted programs effectiveness and implementation in two Canadian provinces Quebec and Ontario
Objectives
1 to translate and adapt iCBT Shyness Program to the Canadian context 2 to examine the completion and effectiveness of the Canadian-adapted including the French translated and English iCBT Shyness Program in improving SAD symptoms 3 to explore barriers and facilitating factors to the programs implementation
Methods
The overall study design is a hybrid effectiveness-implementation study of a quasi-experimental parallel group trial reflecting real world pathways recommended and self-referrals The project will be conducted in two Canadian provinces Quebec Montérégie and Ontario
To build on the current knowledge regarding the effectiveness of guided and unguided iCBT for SAD and inform on generalizability we will evaluate the outcomes associated with the implementation of the program in a three-pathway parallel trial The iCBT Shyness Program includes six online lessons based on CBT strategies with homework assignments to be completed within 90 days The study will be carried out in Quebec and Ontario
Phase 1
Prior to implementing the iCBT Shyness Program it will undergo an initial adaptation to the Canadian context Focus groups in each province will be conducted with key actor groups patients-partners community leaders service providers ie consultant-partners to the research team to discuss the adaptations to the graphics narration of the modules and this to better reflect varying sociocultural context eg socioeconomically disadvantaged environment cultural backgrounds among Canadian French- and English-speaking populations
Phase 2
Then individuals with social anxiety will either 1 self-refer to the adapted intervention self referral undirected iCBT 2 be recommended the adapted intervention by a registered health professional and will complete the program without guidance recommended undirected iCBT or 3 be recommended the adapted intervention by a registered health professional with low intensity guidance throughout the program recommended directed iCBT The program will be implemented via the virtual clinic at Université de Sherbrooke wwwequiliaca as we have acquired and implemented a license for the virtual clinic in Canada Data collection will be integrated into the virtual clinic web platform and the REDCap platform and carried out at baseline at the beginning of each lesson 12-week and 6-month follow-up Individual-level outcomes measured will include anxiety and depressive symptoms psychological distress disability health-related quality of life as well as health service utilization and satisfaction
Phase 3
As a last step to this trial semi-structured interviews will be conducted with study participants and health care providers to explore facilitating factors and barriers to the implementation of the iCBT adapted program and this to inform implementation strategies for wider use across Canada
Anticipated results
This study will provide evidence on the effectiveness barriers and facilitating factors to implementing a low-intensity iCBT in the Canadian context for SAD which will bridge an important care gap for undeserved populations in Canada with SAD Findings will inform the eventual scaling up of the program in community-based primary health care across Canada This would improve equity of the health care system by helping a large number of Canadians including those from visible socio-cultural and linguistic minority groups timely access to mental health services post-pandemic
Objectives
1 to translate and adapt iCBT Shyness Program to the Canadian context 2 to examine the completion and effectiveness of the Canadian-adapted including the French translated and English iCBT Shyness Program in improving SAD symptoms 3 to explore barriers and facilitating factors to the programs implementation
Methods
The overall study design is a hybrid effectiveness-implementation study of a quasi-experimental parallel group trial reflecting real world pathways recommended and self-referrals The project will be conducted in two Canadian provinces Quebec Montérégie and Ontario
To build on the current knowledge regarding the effectiveness of guided and unguided iCBT for SAD and inform on generalizability we will evaluate the outcomes associated with the implementation of the program in a three-pathway parallel trial The iCBT Shyness Program includes six online lessons based on CBT strategies with homework assignments to be completed within 90 days The study will be carried out in Quebec and Ontario
Phase 1
Prior to implementing the iCBT Shyness Program it will undergo an initial adaptation to the Canadian context Focus groups in each province will be conducted with key actor groups patients-partners community leaders service providers ie consultant-partners to the research team to discuss the adaptations to the graphics narration of the modules and this to better reflect varying sociocultural context eg socioeconomically disadvantaged environment cultural backgrounds among Canadian French- and English-speaking populations
Phase 2
Then individuals with social anxiety will either 1 self-refer to the adapted intervention self referral undirected iCBT 2 be recommended the adapted intervention by a registered health professional and will complete the program without guidance recommended undirected iCBT or 3 be recommended the adapted intervention by a registered health professional with low intensity guidance throughout the program recommended directed iCBT The program will be implemented via the virtual clinic at Université de Sherbrooke wwwequiliaca as we have acquired and implemented a license for the virtual clinic in Canada Data collection will be integrated into the virtual clinic web platform and the REDCap platform and carried out at baseline at the beginning of each lesson 12-week and 6-month follow-up Individual-level outcomes measured will include anxiety and depressive symptoms psychological distress disability health-related quality of life as well as health service utilization and satisfaction
Phase 3
As a last step to this trial semi-structured interviews will be conducted with study participants and health care providers to explore facilitating factors and barriers to the implementation of the iCBT adapted program and this to inform implementation strategies for wider use across Canada
Anticipated results
This study will provide evidence on the effectiveness barriers and facilitating factors to implementing a low-intensity iCBT in the Canadian context for SAD which will bridge an important care gap for undeserved populations in Canada with SAD Findings will inform the eventual scaling up of the program in community-based primary health care across Canada This would improve equity of the health care system by helping a large number of Canadians including those from visible socio-cultural and linguistic minority groups timely access to mental health services post-pandemic
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