Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety

ConditionSocial Anxiety

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversité de Sherbrooke

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

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/).
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, 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/).

Treatment groups

252 Participants

are divided into 3 treatment groups

Group A: Self-referred, undirected iCBTExperimental treatment 1 intervention

Group B: Recommended, undirected iCBTExperimental treatment 1 intervention

Group C: Recommended, directed iCBTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame