RecruitingNot ApplicableNCT05292612

CvC-SAD (Clinician vs Coach)Self-help Versions in a RCT

Chinese Internet-delivered Cognitive Therapy for Social Anxiety Disorder in Hong Kong: A Randomised Controlled Noninferiority Trial to Compare Clinician Versus Coach Guidance

Sponsor

Chinese University of Hong Kong

Enrollment

110 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Social Anxiety Disorder

Summary

Background: Social Anxiety Disorder (SAD) is a common mental problem, where people experience severe and disabling anxiety about social situations and interactions. It is highly prevalent world-wide and in Hong Kong, causing significant suffering/distress. While evidence-based interventions exist, e.g., cognitive behavioural therapy (CBT), there will be not enough trained therapists to meet the treatment demand so that the majority of the SAD patients receive no treatment. Internet-based therapies may offer a solution, given that they deliver treatment more cost-efficiently by requiring lesser therapist time so that more patients can be treated with the same therapist resources. One UK internet-based CBT protocol for SAD, iCBT(C\&W), shows high efficacy and efficiency in initial UK and Hong Kong trials with Englishspeaking patients. Objectives: 1. To develop and confirm the efficacy of a Chinese-language version of iCBT(C\&W), administered by clinical psychologists in standard therapist-guided format. 2. To develop an even more cost-efficient new self-help format with some minimal 'coaching' performed by trained psychology bachelor-level graduates - its efficacy expected as 'noninferior' to that of the therapist-guided format. Overall design: Three-arm parallel group randomised controlled noninferiority trial: Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD vs. Waitlist Method: The iCBT(C\&W) protocol will be translated into Chinese. Approximately 110 Chinese adults with SAD will be recruited in Hong Kong and randomised into one of two treatment conditions, therapist-guided versus self-help. The treatment lasts 14 weeks. The primary outcome measure will be Liebowitz Social Anxiety Scale (self-report version).

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study compares two versions of a self-help therapy for social anxiety disorder (SAD) — one guided by a clinician and one guided by a trained non-professional coach — to see which works better. The therapy is delivered online. **You may be eligible if...** - You meet diagnostic criteria (DSM-5) for generalized social anxiety disorder - You consider social anxiety your main problem - You are 18 or older - You are not on psychiatric medication, or have been on a stable dose without improvement for at least 2 months - You are a Chinese resident of Hong Kong and are fluent in written traditional Chinese and spoken Cantonese - You have internet access at home **You may NOT be eligible if...** - You have a history of psychosis, bipolar disorder, or borderline personality disorder - You have active suicidal thoughts - You have moderate or severe alcohol or substance use disorder - You have previously received CBT (talk therapy) specifically for social anxiety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALiCBT(C&W) for SAD

iCBT(C\&W) for SAD implements all the key procedures of the face-to-face treatment. Patients are guided through the treatment by using secure messaging and regular telephone or webcam calls. The treatment comprises a series of online modules, each of which includes educational texts, patient testimonies, video illustrations, case examples, questionand- answer boxes, monitoring sheets, behavioural experiments and other homework assignments.