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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test an online Cognitive Behavioral Therapy (CBT) program designed to reduce social anxiety symptoms. Participants will use the program independently or with guidance from a healthcare professional. The trial will assess the program's effectiveness and identify factors that aid or impede its use in real-world settings. Individuals with social anxiety who have internet access and speak English or French may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to the understanding and improvement of mental health treatments.

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 prior data suggests that this Internet Cognitive Behavioral Therapy is safe for treating social anxiety?

Research has shown that internet-based cognitive behavioral therapy (iCBT) for social anxiety disorder is generally safe and well-tolerated. Studies have found that this therapy effectively reduces anxiety symptoms and poses no significant safety concerns. For instance, two different studies reported no major negative effects from the iCBT program.

Moreover, the iCBT program for social anxiety has been tested and found acceptable to users, with participants reporting no significant problems or side effects. Overall, current evidence suggests that iCBT is a safe option for managing social anxiety symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Internet Cognitive Behavioral Therapy (iCBT) for social anxiety because it offers a unique, flexible approach compared to traditional in-person therapy sessions or medication. iCBT allows individuals to access therapy online, making it more accessible and convenient for those who might struggle with scheduling or attending in-person appointments. Additionally, iCBT can be tailored to different levels of support: some participants can work through the program independently, while others receive guidance from healthcare professionals via email or brief phone calls. This approach not only potentially reduces the stigma associated with seeking mental health treatment but also provides options for personalized care depending on individual needs.

What evidence suggests that Internet Cognitive-behavioral Therapy might be an effective treatment for social anxiety?

Research has shown that online cognitive-behavioral therapy (iCBT) effectively treats social anxiety disorder (SAD). Studies indicate that people using iCBT often experience significant symptom improvements. For instance, one study found that about 34% to 40% of participants showed noticeable improvement with iCBT, compared to only 11% in a group that did not receive the therapy. In this trial, participants will be assigned to different arms to evaluate the effectiveness of iCBT with varying levels of guidance. One arm will involve self-referred, undirected iCBT, while another will include recommended, undirected iCBT. A third arm will assess recommended, directed iCBT, where participants receive low-intensity guidance. Another study found that iCBT can be effective even without direct guidance from a therapist. Overall, iCBT has proven to be a valuable tool in helping people manage and reduce their social anxiety. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4418823/

Internet-Delivered Cognitive-Behavioral Therapy for Social ... Internet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2214782914000311

The effectiveness of internet cognitive behaviour therapy ... Results provide evidence of the effectiveness of iCBT for social anxiety disorder when delivered in routine practice.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40274120/

A randomized controlled trial in Hong Kong The rate of reliable improvement based on the SPIN was 34 % and 40 % in the web-based and app-based iCBT groups, respectively, compared to 11 % in the WLC group ...

4. pediatrics.jmir.org pediatrics.jmir.org/2024/1/e55786/

Effectiveness of Unguided Internet-Based Cognitive ... The results of this randomized controlled trial show that fully unguided ICBT improves subthreshold SAD in adolescents and young adults.

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2779637

Therapist-Guided Internet-Delivered Cognitive Behavioral ... The efficacy of internet-delivered CBT (ICBT) for adults with SAD has been well established,11 but only 1 large randomized clinical trial of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40208666/

Safety and Efficacy of Modular Digital Psychotherapy for ... Conclusions: The web-only, modular social anxiety CBT program appeared safe, acceptable, and efficacious in 2 independent RCTs on online patient ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0887618525001094

Intensive 7-day internet-delivered cognitive behavioural ... The iCBT group reported significantly lower social anxiety symptoms (Hedges' g's >.96), and functional impairment at post and one-month follow- ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725006755

Effectiveness of internet-based cognitive behavioral ... The rate of reliable improvement based on the SPIN was 34 % and 40 % in the web-based and app-based iCBT groups, respectively, compared to 11 % ...