Internet Cognitive Behavioral Therapy for Social Anxiety
(iCBT-SAD Trial)
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.12345Why 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.14678
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
Timeline for a Trial Participant
Adaptation
Initial adaptation of the iCBT Shyness Program to the Canadian context, including focus groups to discuss adaptations.
Implementation
Implementation of the adapted iCBT Shyness Program with three pathways: self-referred, recommended undirected, and recommended directed.
Follow-up
Participants are monitored for outcomes such as anxiety and depressive symptoms, psychological distress, and health-related quality of life.
Evaluation
Semi-structured interviews with participants and healthcare providers to explore barriers and facilitating factors for program implementation.
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?
3
Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Université de Sherbrooke
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Published Research Related to This Trial
Citations
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 ...
The effectiveness of internet cognitive behaviour therapy ...
Results provide evidence of the effectiveness of iCBT for social anxiety disorder when delivered in routine practice.
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 ...
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.
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 ...
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 ...
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- ...
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 % ...
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