Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety

NCT06403995 | Recruiting DMC

• 1 other identifier: 2023-4843
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 2

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

Keywords

Anxiety; Social anxiety; Internet Cognitive behavioural therapy; Community-based primary health care; Quasi-experimental design; Canada

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  Baseline to post-treatment (12-week and 6-month follow-up post-treatment)

• Change in Health-related quality of life (HRQOL)

  Baseline to post-treatment (12-week and 6-month follow-up post-treatment)

• Change on the Kessler Psychological Distress Scale (K10)

  Baseline to post-treatment (12-week and 6-month follow-up post-treatment)

• Change in Patient Health Questionnaire-8 (PHQ-8)

  Baseline to post-treatment (12-week and 6-month follow-up post-treatment)

• Change in generalized anxiety disorder scale (GAD-7)

  Baseline to post-treatment (12-week and 6-month follow-up post-treatment)

Other Outcomes (1)

• Change in loneliness and social isolation

  Baseline to post-treatment (12-week and 6-month follow-up post-treatment)

Study Arms (3)

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.

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.

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.

Behavioral: Recommended, directed Internet-based cognitive behavioral therapy for social anxiety

Interventions

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

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/).

Self-referred, undirected iCBT

Recommended, undirected Internet-based cognitive behavioral therapy for social anxiety BEHAVIORAL

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 iCBT

Recommended, directed Internet-based cognitive behavioral therapy for social anxiety BEHAVIORAL

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 iCBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

CISSS de la Montérégie-Centre

Greenfield Park, Quebec, J4V 2G9, Canada

RECRUITING

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 39379845 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Helen-Maria Vasiliadis, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: April 4, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)