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

NCT05292612 | Recruiting

• 1 other identifier: 2022.086-T
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (22)

• Patient Health Questionnaire-Depression Scale (PHQ-9)

  through study completion, an average of 14 weeks

• Patient Health Questionnaire-Depression Scale (PHQ-9)

  at 3-month post-treatment follow-up

• Patient Health Questionnaire-Depression Scale (PHQ-9)

  at 9-month post-treatment follow-up

• Generalized Anxiety Disorder-7 (GAD-7)

  through study completion, an average of 14 weeks

• Generalized Anxiety Disorder-7 (GAD-7)

  at 3-month post-treatment follow-up

Study Arms (3)

Standard therapist-guided iCT-SAD vs. Waitlist

EXPERIMENTAL

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.

Behavioral: iCBT(C&W) for SAD

Guided self-help iCT-SAD vs. Waitlist

EXPERIMENTAL

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.

Behavioral: iCBT(C&W) for SAD

Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD

EXPERIMENTAL

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.

Behavioral: iCBT(C&W) for SAD

Interventions

iCBT(C&W) for SAD BEHAVIORAL

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.

Guided self-help iCT-SAD vs. Waitlist; Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD; Standard therapist-guided iCT-SAD vs. Waitlist

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Patrick Leung, Prof.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Leung, Prof.

CONTACT

+85239436502; pleung@cuhk.edu.hk

Candace Ng

CONTACT

+85298046936; candace.ng@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 23, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)