NCT05292612 CvC-SAD (Clinician vs Coach)Self-help Versions in a RCT
| NCT ID | NCT05292612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Social Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-05-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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)
Contact & Investigator
Patrick Leung, Prof.
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT05292612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Social Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05292612 currently recruiting?
Yes, NCT05292612 is actively recruiting participants. Contact the research team at pleung@cuhk.edu.hk for enrollment information.
Where is the NCT05292612 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT05292612 clinical trial?
NCT05292612 is sponsored by Chinese University of Hong Kong. The principal investigator is Patrick Leung, Prof. at Chinese University of Hong Kong. The trial plans to enroll 110 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.