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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorChinese University of Hong Kong

About this trial

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

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • iCBT(C&W) for SAD

Treatment groups

110 Participants
are divided into 3 treatment groups