Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety

Study Details

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 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.

Conditions

Social Anxiety

Study ID

NCT06403995

Start date

Apr 4, 2025

Status verified date

Apr, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Study Design

Enrollment

252 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self-referred, undirected iCBT

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.

experimental: Recommended, undirected iCBT

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.

experimental: Recommended, directed iCBT

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.

Interventions

Self-referred, undirected Internet-based cognitive behavioral therapy for social anxiety

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 anxiety

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 anxiety

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/).

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) ]

Central Contacts and Locations

Central contacts

Helen-Maria Vasiliadis, PhD

(450) 466-5000 helen-maria.vasiliadis@usherbrooke.ca

Locations

CISSS de la Montérégie-Centre

Recruiting

Greenfield Park, Quebec, Canada, J4V 2G9

Contacts

Helen-Maria Vasiliadis, Ph.D.

450 466-5000 helen-maria.vasiliadis@usherbrooke.ca

CIUSSS de l'Estrie - CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5H3

Contacts

Helen-Maria Vasiliadis, Ph.D.

450 466-5000 helen-maria.vasiliadis@usherbrooke.ca

Cognitive-Behavioral TherapyEvidence-based Internet Cognitive-behavioral Therapy for Social Anxiety

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

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