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

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05292612
• Other study ID #: 2022.086-T
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2023
• Source: Chinese University of Hong Kong
• Contact: Patrick Leung, Prof.
• Phone: +85239436502
• Email: pleung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion

• Meets DSM-5 criteria for SAD (SAD must be generalised, not the 'performance only' subtype)

• Considers SAD their main problem

• Age 18 or over (no upper age limit)

• No current psychotropic mediation, or on a stable dose for at least two months without improvement, and willing to remain at this dose throughout trial

• Participant agrees not to start any other forms of treatment during the trial

• Chinese resident of Hong Kong

• Proficient in written traditional Chinese and spoken Cantonese

• Internet access from home

Exclusion

• current or past psychosis, bipolar disorder, or borderline personality disorder

• active suicidality

• 'Moderate' or 'Severe' Alcohol Use Disorder or Substance Use Disorder (based on DSM-5)

• No current or previous CBT for SAD (defined as at least 5 sessions, and including an exposure component), including internet-CBT studies

• Not another current emotional problem that is the participant's main concern (Participant must not be largely absorbed in another emotional problem, for which it would be unethical not to address as a priority)

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• iCBT(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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebowitz Social Anxiety Scale, Self-report version (LSAS)	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.	through study completion, an average of 14 weeks
Primary	Liebowitz Social Anxiety Scale, Self-report version (LSAS)	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.	at 3-month post-treatment follow-up
Primary	Liebowitz Social Anxiety Scale, Self-report version (LSAS)	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.	at 9-month post-treatment follow-up
Secondary	Patient Health Questionnaire-Depression Scale (PHQ-9)	PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder	through study completion, an average of 14 weeks
Secondary	Patient Health Questionnaire-Depression Scale (PHQ-9)	PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder	at 3-month post-treatment follow-up
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders	through study completion, an average of 14 weeks
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders	at 3-month post-treatment follow-up
Secondary	Work and Social Adjustment Scale (WSAS)	WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD)	through study completion, an average of 14 weeks
Secondary	Work and Social Adjustment Scale (WSAS)	WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD)	at 3-month post-treatment follow-up
Secondary	Social Phobia Weekly Summary Scale (SPWSS)	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.	through study completion, an average of 14 weeks
Secondary	Social Phobia Weekly Summary Scale (SPWSS)	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.	at 3-month post-treatment follow-up