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

Recruiting · NCT05292612 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong

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Anxiety

Interventions studied

iCBT(C&W) for SAD

What this trial is about

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).

Who can take part

Age range

18 Years to 100 Years

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

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)

Where it is running

1 location listed.

The Chinese University of Hong Kong - Shatin, Hong Kong

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →