Social AnxietyiCBT-SADNCT06403995
Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety
A study testing Self-referred, undirected Internet-based cognitive behavioral therapy for social anxiety, Recommended, undirected Internet-based cognitive behavioral therapy for social anxiety and Recommended, directed Internet-based cognitive behavioral therapy for social anxiety in people with Social Anxiety, run by Université de Sherbrooke at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Self-referred, undirected Internet-based cognitive behavioral therapy for social anxiety, Recommended, undirected Internet-based cognitive behavioral therapy for social anxiety and Recommended, directed Internet-based cognitive behavioral therapy for social anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years; and
- Speak and write in French or English; and
- Have access to the internet and a digital device; and
- Screen for social anxiety using the 17-item Social Phobia Inventory (SPIN) questionnaire (> 20).
Who cannot join
- Self-report severe symptoms of depressions (PHQ-9 score ≥ 23); or
- Thoughts they would be better off dead or hurting themselves on the 9th item of PHQ-9 in the past two weeks or thoughts or wishes to kill themselves on the 9th item of the Beck Depression Inventory-II; or
- A diagnosis of schizophrenia, bipolar disorder or problems related to active substance use or dependence; or
- Current use of benzodiazepines.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
CISSS de la Montérégie-Centre
Greenfield Park, Quebec, J4V 2G9
Helen-Maria Vasiliadis, Ph.D., 450 466-5000 ext. 3701, helen-maria.vasiliadis@usherbrooke.ca
- Recruiting
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5H3
Helen-Maria Vasiliadis, Ph.D., 450 466-5000 ext. 3701, helen-maria.vasiliadis@usherbrooke.ca
About this study
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 program's 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.
Read the 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 Australia's Shyness Program and to examine the adapted program's effectiveness, and implementation in two Canadian provinces (Quebec and Ontario).
Objectives
- 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 program's 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, i.e., 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 (e.g., 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 (www.equilia.ca), 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.
- Conditions
- Social Anxiety
- Being tested
- Self-referred, undirected Internet-based cognitive behavioral therapy for social anxiety, Recommended, undirected Internet-based cognitive behavioral therapy for social anxiety, Recommended, directed Internet-based cognitive behavioral therapy for social anxiety
- Keywords
- Anxiety, Social anxiety, Internet Cognitive behavioural therapy, Community-based primary health care, Quasi-experimental design, Canada
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-referred, undirected Internet-based cognitive behavioral therapy for social anxietyBehavioural
The Shyness Program is presented in the form of illustrated stories of a working woman and young man with SAD and their health professional (a psychologist). The program comprises six online lessons that teach core cognitive and behavioral principles and skills, including psychoeducation about the symptoms and treatment of SAD (Lessons 1-2); graded exposure and behavioral experiments (Lesson 3); cognitive restructuring (Lessons 4-5); relapse prevention (Lesson 6). The program also includes lesson summaries, homework assignments, and regular scheduled emails to support program users in applying the CBT skills themselves (N. Titov, Andrews, Schwencke, et al., 2008). It is recommended that modules are completed every 1 to 2 weeks with the full program completed within 90 days (see https://thiswayup.org.au/courses/the-social-anxiety-course/).
Recommended, undirected Internet-based cognitive behavioral therapy for social anxietyBehavioural
The Shyness Program is presented in the form of illustrated stories of a working woman and young man with SAD and their health professional (a psychologist). The program comprises six online lessons that teach core cognitive and behavioral principles and skills, including psychoeducation about the symptoms and treatment of SAD (Lessons 1-2); graded exposure and behavioral experiments (Lesson 3); cognitive restructuring (Lessons 4-5); relapse prevention (Lesson 6). The program also includes lesson summaries, homework assignments, and regular scheduled emails to support program users in applying the CBT skills themselves (N. Titov, Andrews, Schwencke, et al., 2008). It is recommended that modules are completed every 1 to 2 weeks with the full program completed within 90 days (see https://thiswayup.org.au/courses/the-social-anxiety-course/).
Recommended, directed Internet-based cognitive behavioral therapy for social anxietyBehavioural
The Shyness Program is presented in the form of illustrated stories of a working woman and young man with SAD and their health professional (a psychologist). The program comprises six online lessons that teach core cognitive and behavioral principles and skills, including psychoeducation about the symptoms and treatment of SAD (Lessons 1-2); graded exposure and behavioral experiments (Lesson 3); cognitive restructuring (Lessons 4-5); relapse prevention (Lesson 6). The program also includes lesson summaries, homework assignments, and regular scheduled emails to support program users in applying the CBT skills themselves (N. Titov, Andrews, Schwencke, et al., 2008). It is recommended that modules are completed every 1 to 2 weeks with the full program completed within 90 days (see https://thiswayup.org.au/courses/the-social-anxiety-course/).
| Study group | Role | What they receive |
|---|---|---|
| Self-referred, undirected iCBT | Experimental | These individuals will do the program, but will not receive follow-up contact during the program. In case of severe psychological distress (i.e. score ≥30 on Kessler's 10-item psychological distress scale (K10), participants will receive an automated email with a list of resources and emergency contact numbers. Receives: Behavioral: Self-referred, undirected Internet-based cognitive behavioral therapy for social anxiety |
| Recommended, undirected iCBT | Experimental | Participants will have received the recommendation from a healthcare professional (e.g., family physician, nurse or social worker, psychologist) to complete the adapted program without guidance. Clinicians will provide the name and email of the patients they are referring the program to without providing participants with in-program support but will consult the dashboard as they have clinical responsibility for the patient. In case of severe distress (i.e., K10 score ≥30), the referring healthcare professional will receive an automated email informing them to go to their dashboard to identify that patient. Participants will also receive an automated email with a list of resources and emergency contact numbers. To support the generalization of findings to the real-world (ecological validity), clinicians may follow-up with patients at their discretion. Receives: Behavioral: Recommended, undirected Internet-based cognitive behavioral therapy for social anxiety |
| Recommended, directed iCBT | Experimental | Participants will be recommended the intervention by a healthcare professional and be provided low-intensity guidance (e.g., email or brief phone contact [5 to 10 minutes] after Lesson 1 and 2, and then on an as-needed basis or patient request). Clinicians at the primary care sites participating in the study will be able to recommend the adapted program to their patients, will remain responsible for their patients and, will check their dashboard to see how their patients are progressing through the program. In the event of severe distress (i.e., K10 score ≥30) in a patient, the referring healthcare professional will receive an automated email informing them to go to their dashboard to identify that patient and assess the appropriate action to take. Participants will also receive an automated email with a list of resources and emergency contact numbers. Receives: Behavioral: Recommended, directed Internet-based cognitive behavioral therapy for social anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Social Phobia Inventory (SPIN)
Social Phobia Inventory (SPIN). The 17-item SPIN questionnaire will be used to assess social anxiety symptoms, which are rated on a 5-point scale from 0 (not at all) to 4 (extremely), with a possible score range from 0 to 68 (Connor et al., 2000). A cut-off > 20 has been shown to reflect a probable case of SAD (Davidson, 2020).
Measured: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Secondary outcomes (8)
Change on the World Health Organization Disability Assessment Schedule (WHODAS 2.0)
World Health Organization Disability Assessment Schedule (WHODAS 2.0) (Andrews, Kemp, Sunderland, Von Korff, \& Ustun, 2009). The 12-item schedule measures activity limitations in the past 30 days in 6 domains (possible score range 0 to 60), will also be used to assess disability.
Measured: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Change in Health-related quality of life (HRQOL)
Health-related quality of life (HRQOL) will be ascertained with the four-dimension Assessment of Quality of Life (AQoL-4D) (Hawthorne G, Richardson J, Osborne R, 1999; Hawthorne G, Richarson J, Day NA, 2001) including 12 items on 4 dimensions: independent living, mental health, relationships, senses. Scoring will be based on available weights and utility scores range from 0 to 1.0 (AQol, 2014; Richardson et al., 2014).
Measured: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Change on the Kessler Psychological Distress Scale (K10)
Kessler Psychological Distress Scale (K10) (Kessler et al., 2002). The 10-item scale assesses psychological distress on a 5-point scale with scores ranging from 10 to 50. Scores ≥30 correspond to severe distress and an alert is sent to the study team, the participant, and referring health professional.
Measured: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Change in Patient Health Questionnaire-8 (PHQ-8)
Patient Health Questionnaire (PHQ-8). The 8-item questionnaire will be used to assess depressive symptoms. Symptoms are rated on a 0 (not at all) to 3 (nearly every day) point scale, with scores ranging from 0 to 24. A cut-off score ≥10 is used to identify a probable major depressive disorder (Kroenke et al., 2009).
Measured: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Change in generalized anxiety disorder scale (GAD-7)
Generalized Anxiety Scale (GAD-7). The 7-iem questionnaire will be used to assess generalized anxiety symptoms with scores ranging from 0 to 21. A cut-off score ≥10 is used to identify probable anxiety (Spitzer, Kroenke, Williams, \& Löwe, 2006).
Measured: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Past 3 and 6-month health and social service use
Past 3 and 6-month health and social service use (any emergency department visit, any hospitalisation, visit to a health professional, receipt of services from local community service centre, psychotropic drug use).
Measured: Baseline and 6-month post-treatment
Self-reported satisfaction with iCBT program
As in Williams et al., (2014) (Williams et al., 2014), self-reported satisfaction with the iCBT program will be assessed with a 5-point scale assessing how satisfied individuals were with the program: 1= very dissatisfied to 5=very satisfied; and how confident participants are in recommending the program to a family member/friend with social anxiety (1=not at all to 10= extremely confident).
Measured: 12-week post-treatment
Contacts with referring prescriber
Number of contacts (e.g. consultations) with referring prescriber of the program
Measured: 6-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start4 Apr 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403995
- Sponsor's protocol ID
- 2023-4843
- Acronym
- iCBT-SAD
- Status last verified
- Apr 2025
- First submitted
- 3 May 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors are not legally authorised to share or publicly publish participants' data. Participants were not requested to give informed consent for public data sharing. Requests for access to the data should be addressed to the Ethics Committee Board of the Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke.
Publications
Vasiliadis HM, Roberge P, Spagnolo J, Lamoureux-Lamarche C, Chapdelaine A, Brodeur M, Grenier J, Mahoney A, Koszycki D, Chomienne MH, Drapeau M, Labelle R, Provencher MD, Ishimo MC, Naslund JA, Lesage A. A digital iCBT intervention for social anxiety disorder in Quebec and Ontario: protocol for a multi-phase effectiveness-implementation study. BMC Psychiatry. 2024 Oct 8;24(1):662. doi: 10.1186/s12888-024-06082-7.
PubMed 39379845
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety
- ClinicalTrials.gov ID
- NCT06403995
- Acronym / sponsor ID
- iCBT-SAD / 2023-4843
- Conditions
- Social Anxiety
- Keywords
- Anxiety, Social anxiety, Internet Cognitive behavioural therapy, Community-based primary health care, Quasi-experimental design, Canada
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 2024 (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 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 program's 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 Australia's Shyness Program and to examine the adapted program's effectiveness, and implementation in two Canadian provinces (Quebec and Ontario).
Objectives
- 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 program's 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, i.e., 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 (e.g., 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 (www.equilia.ca), 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Self-referred, undirected iCBT | Experimental | Behavioral: Self-referred, undirected Internet-based cognitive behavioral therapy for social anxietyThese individuals will do the program, but will not receive follow-up contact during the program. In case of severe psychological distress (i.e. score ≥30 on Kessler's 10-item psychological distress scale (K10), participants will receive an automated email with a list of resources and emergency contact numbers. |
| Recommended, undirected iCBT | Experimental | Behavioral: Recommended, undirected Internet-based cognitive behavioral therapy for social anxietyParticipants will have received the recommendation from a healthcare professional (e.g., family physician, nurse or social worker, psychologist) to complete the adapted program without guidance. Clinicians will provide the name and email of the patients they are referring the program to without providing participants with in-program support but will consult the dashboard as they have clinical responsibility for the patient. In case of severe distress (i.e., K10 score ≥30), the referring healthcare professional will receive an automated email informing them to go to their dashboard to identify that patient. Participants will also receive an automated email with a list of resources and emergency contact numbers. To support the generalization of findings to the real-world (ecological validity), clinicians may follow-up with patients at their discretion. |
| Recommended, directed iCBT | Experimental | Behavioral: Recommended, directed Internet-based cognitive behavioral therapy for social anxietyParticipants will be recommended the intervention by a healthcare professional and be provided low-intensity guidance (e.g., email or brief phone contact [5 to 10 minutes] after Lesson 1 and 2, and then on an as-needed basis or patient request). Clinicians at the primary care sites participating in the study will be able to recommend the adapted program to their patients, will remain responsible for their patients and, will check their dashboard to see how their patients are progressing through the program. In the event of severe distress (i.e., K10 score ≥30) in a patient, the referring healthcare professional will receive an automated email informing them to go to their dashboard to identify that patient and assess the appropriate action to take. Participants will also receive an automated email with a list of resources and emergency contact numbers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18 years; and
- Speak and write in French or English; and
- Have access to the internet and a digital device; and
- Screen for social anxiety using the 17-item Social Phobia Inventory (SPIN) questionnaire (> 20).
Key exclusion criteria (4 listed)
- Self-report severe symptoms of depressions (PHQ-9 score ≥ 23); or
- Thoughts they would be better off dead or hurting themselves on the 9th item of PHQ-9 in the past two weeks or thoughts or wishes to kill themselves on the 9th item of the Beck Depression Inventory-II; or
- A diagnosis of schizophrenia, bipolar disorder or problems related to active substance use or dependence; or
- Current use of benzodiazepines.
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 |
|---|---|---|
| Self-referred, undirected Internet-based cognitive behavioral therapy for social anxietyThe Shyness Program is presented in the form of illustrated stories of a working woman and young man with SAD and their health professional (a psychologist). The program comprises six online lessons that teach core cognitive and behavioral principles and skills, including psychoeducation about the symptoms and treatment of SAD (Lessons 1-2); graded exposure and behavioral experiments (Lesson 3); cognitive restructuring (Lessons 4-5); relapse prevention (Lesson 6). The program also includes lesson summaries, homework assignments, and regular scheduled emails to support program users in applying the CBT skills themselves (N. Titov, Andrews, Schwencke, et al., 2008). It is recommended that modules are completed every 1 to 2 weeks with the full program completed within 90 days (see https://thiswayup.org.au/courses/the-social-anxiety-course/). | Behavioural | Self-referred, undirected iCBT |
| Recommended, undirected Internet-based cognitive behavioral therapy for social anxietyThe Shyness Program is presented in the form of illustrated stories of a working woman and young man with SAD and their health professional (a psychologist). The program comprises six online lessons that teach core cognitive and behavioral principles and skills, including psychoeducation about the symptoms and treatment of SAD (Lessons 1-2); graded exposure and behavioral experiments (Lesson 3); cognitive restructuring (Lessons 4-5); relapse prevention (Lesson 6). The program also includes lesson summaries, homework assignments, and regular scheduled emails to support program users in applying the CBT skills themselves (N. Titov, Andrews, Schwencke, et al., 2008). It is recommended that modules are completed every 1 to 2 weeks with the full program completed within 90 days (see https://thiswayup.org.au/courses/the-social-anxiety-course/). | Behavioural | Recommended, undirected iCBT |
| Recommended, directed Internet-based cognitive behavioral therapy for social anxietyThe Shyness Program is presented in the form of illustrated stories of a working woman and young man with SAD and their health professional (a psychologist). The program comprises six online lessons that teach core cognitive and behavioral principles and skills, including psychoeducation about the symptoms and treatment of SAD (Lessons 1-2); graded exposure and behavioral experiments (Lesson 3); cognitive restructuring (Lessons 4-5); relapse prevention (Lesson 6). The program also includes lesson summaries, homework assignments, and regular scheduled emails to support program users in applying the CBT skills themselves (N. Titov, Andrews, Schwencke, et al., 2008). It is recommended that modules are completed every 1 to 2 weeks with the full program completed within 90 days (see https://thiswayup.org.au/courses/the-social-anxiety-course/). | Behavioural | Recommended, directed iCBT |
Primary outcome
Change on the Social Phobia Inventory (SPIN)
Time frame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Social Phobia Inventory (SPIN). The 17-item SPIN questionnaire will be used to assess social anxiety symptoms, which are rated on a 5-point scale from 0 (not at all) to 4 (extremely), with a possible score range from 0 to 68 (Connor et al., 2000). A cut-off > 20 has been shown to reflect a probable case of SAD (Davidson, 2020).
8 secondary outcomes
Change on the World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Time frame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Change in Health-related quality of life (HRQOL)
Time frame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Change on the Kessler Psychological Distress Scale (K10)
Time frame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Change in Patient Health Questionnaire-8 (PHQ-8)
Time frame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Change in generalized anxiety disorder scale (GAD-7)
Time frame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Past 3 and 6-month health and social service use
Time frame: Baseline and 6-month post-treatment
Self-reported satisfaction with iCBT program
Time frame: 12-week post-treatment
Contacts with referring prescriber
Time frame: 6-month post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 39379845Vasiliadis HM, Roberge P, Spagnolo J, Lamoureux-Lamarche C, Chapdelaine A, Brodeur M, Grenier J, Mahoney A, Koszycki D, Chomienne MH, Drapeau M, Labelle R, Provencher MD, Ishimo MC, Naslund JA, Lesage A. A digital iCBT intervention for social anxiety disorder in Quebec and Ontario: protocol for a multi-phase effectiveness-implementation study. BMC Psychiatry. 2024 Oct 8;24(1):662. doi: 10.1186/s12888-024-06082-7.
- Individual participant dataSharing planned: No. The authors are not legally authorised to share or publicly publish participants' data. Participants were not requested to give informed consent for public data sharing. Requests for access to the data should be addressed to the Ethics Committee Board of the Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-referred, undirected Internet-based cognitive behavioral therapy for social anxiety, Recommended, undirected Internet-based cognitive behavioral therapy for social anxiety and Recommended, directed Internet-based cognitive behavioral therapy for social anxiety in people with Social Anxiety, run by Université de Sherbrooke at 2 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen-Maria Vasiliadis, PhD ((450) 466-5000 ext. 3701, helen-maria.vasiliadis@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the Social Phobia Inventory (SPIN) (time frame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403995, which also lists 1 linked publication.
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 30 May 2025.