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

Not Applicable

Not yet recruiting

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: iCBT(C&W) for SAD

• Registration Number: NCT05292612
• Lead Sponsor: Chinese University of Hong Kong

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17
• Study Start: 2023-05-01
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapist-guided iCT-SAD vs. Waitlist	iCBT(C&W) for SAD	to examine if standard iCT-SAD delivered in Chinese is superior to waitlist. participants in the experimental group would receive iCBT(C\&W) for SAD under the guidance of trained therapist.
Guided self-help iCT-SAD vs. Waitlist	iCBT(C&W) for SAD	to examine if guided self-help iCT-SAD delivered in Chinese is superior to waitlist. participants in the experimental group would receive iCBT(C\&W) for SAD under the guidance of trained coaches.
Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD	iCBT(C&W) for SAD	to examine if guided self-help iCT-SAD is noninferior to standard iCT-SAD. participants would be randomised into two groups. one group of participants would receive iCBT(C\&W) for SAD under the guidance of trained therapist while the other group of participants would receive iCBT(C\&W) for SAD under the guidance of trained coaches.

Primary Outcome Measures

Name	Time	Method
Liebowitz Social Anxiety Scale, Self-report version (LSAS)	at 9-month post-treatment follow-up	LSAS consists of twenty-four items to assess individual's fear and avoidance towards different social interactions and performance situations. A total of six subscale scores could be obtained in LSAS, including the total fear, fear of social interactions, fear of performance situations, total avoidance, avoidance of social interactions, and avoidance of performance situations.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-Depression Scale (PHQ-9)	at 3-month post-treatment follow-up	PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder
Generalized Anxiety Disorder-7 (GAD-7)	at 3-month post-treatment follow-up	GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders
Work and Social Adjustment Scale (WSAS)	at 3-month post-treatment follow-up	WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD)
Social Phobia Weekly Summary Scale (SPWSS)	at 3-month post-treatment follow-up	SPWSS is a five-item self-report questionnaire on social anxiety, social avoidance, self-focused versus external-focused attention, anticipatory processing, and post-event rumination.