Internet Cognitive Behavioral Therapy for Social Anxiety

(iCBT-SAD Trial)

Recruiting at 1 trial location

Overseen By Helen-Maria Vasiliadis, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: Benzodiazepines

Disqualifiers: Severe depression, Suicidal thoughts, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

252 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial requires that you do not use benzodiazepines (a type of medication often used for anxiety) while participating.

What data supports the effectiveness of the treatment Internet Cognitive-behavioral Therapy for Social Anxiety?

Research shows that Internet-based Cognitive Behavioral Therapy (CBT) can effectively reduce social anxiety symptoms in the short term, with some studies indicating long-term benefits similar to traditional face-to-face CBT. Additionally, a pilot study found significant reductions in social anxiety and depressive symptoms after a 7-day intensive online CBT program. ^{1 2 3 4 5}

Is Internet Cognitive Behavioral Therapy safe for humans?

The research does not specifically address safety concerns, but Internet Cognitive Behavioral Therapy has been tested in multiple studies for social anxiety disorder, suggesting it is generally considered safe for use in humans. ^{1 2 6 7 8}

How is Internet Cognitive Behavioral Therapy different from other treatments for social anxiety?

Internet Cognitive Behavioral Therapy (iCBT) for social anxiety is unique because it allows patients to receive therapy online, which can be more convenient and require less therapist time compared to traditional face-to-face sessions. This approach has been shown to be effective in multiple languages and cultures, making it a flexible option for diverse populations. ^{1 2 8 9 10}

Eligibility Criteria

This trial is for adults over 18 who speak and write in French or English, have internet access with a digital device, and score above 20 on the Social Phobia Inventory indicating social anxiety. It's not specified who can't join.

Inclusion Criteria

I can speak and write in French or English.

I have internet and a digital device.

My SPIN score for social anxiety is above 20.

Timeline

Adaptation

Initial adaptation of the iCBT Shyness Program to the Canadian context, including focus groups to discuss adaptations.

4-6 weeks

Implementation

Implementation of the adapted iCBT Shyness Program with three pathways: self-referred, recommended undirected, and recommended directed.

12 weeks

Virtual sessions and data collection at baseline, beginning of each lesson, 12-week follow-up

Follow-up

Participants are monitored for outcomes such as anxiety and depressive symptoms, psychological distress, and health-related quality of life.

6 months

Data collection at 6-month follow-up

Evaluation

Semi-structured interviews with participants and healthcare providers to explore barriers and facilitating factors for program implementation.

4-6 weeks

Treatment Details

Interventions

• Internet Cognitive-behavioral Therapy

Trial Overview The study tests Internet-based cognitive behavioral therapy (iCBT) for social anxiety in Canada. Participants will try either self-referred undirected iCBT, recommended undirected iCBT, or recommended directed iCBT to see which improves symptoms best.

Participant Groups

Group I: Self-referred, undirected iCBT Experimental Treatment 1 Intervention

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.

Group II: Recommended, undirected iCBT Experimental Treatment 1 Intervention

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.

Group III: Recommended, directed iCBT Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Internet cognitive behavior therapy (CBT) and face-to-face CBT were equally effective in treating social phobia, as shown in a randomized controlled trial with 75 patients, where significant improvements were noted in both groups.

The Internet CBT required significantly less therapist time (18 minutes per patient) compared to face-to-face therapy (240 minutes per patient), suggesting that Internet CBT could allow for more efficient use of resources in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness randomized controlled trial of face to face versus Internet cognitive behaviour therapy for social phobia. Andrews, G., Davies, M., Titov, N.[2022]

Remote cognitive behavior therapy (CBT) for social anxiety disorder (SAD) shows large effect sizes in improving symptoms, with a pooled effect size of 1.06 from pre-treatment to post-treatment based on 31 studies involving 2905 participants.

Remote CBT methods, including internet and application-delivered formats, are more effective than passive controls and non-CBT treatments, and are at least as effective as traditional face-to-face CBT, suggesting they can significantly enhance access to treatment for SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote cognitive behaviour therapy for social anxiety disorder: A meta-analysis. Winter, HR., Norton, AR., Burley, JL., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Therapist experience and knowledge acquisition in internet-delivered CBT for social anxiety disorder: a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness randomized controlled trial of face to face versus Internet cognitive behaviour therapy for social phobia. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Long-term outcome of Internet-delivered cognitive-behavioural therapy for social phobia: a 30-month follow-up. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot study of intensive 7-day internet-based cognitive behavioral therapy for social anxiety disorder. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adolescents' experience of receiving internet-delivered cognitive therapy for social anxiety disorder. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Remote cognitive behaviour therapy for social anxiety disorder: A meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive-behavioral therapy for social anxiety disorder in Romania: a randomized controlled trial. [2020]

9. England pubmed.ncbi.nlm.nih.gov

More than doubling the clinical benefit of each hour of therapist time: a randomised controlled trial of internet cognitive therapy for social anxiety disorder. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Commentary on Berger, Hohl, and Caspar's (2009) Internet-based treatment for social phobia: a randomized controlled trial. [2018]