Clinical trial NCT05292612: CvC-SAD (Clinician vs Coach)Self-help Versions in a RCT
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Primary outcomes:
measure: Liebowitz Social Anxiety Scale, Self-report version (LSAS)
timeFrame: through study completion, an average of 14 weeks
measure: Liebowitz Social Anxiety Scale, Self-report version (LSAS)
timeFrame: at 3-month post-treatment follow-up
measure: Liebowitz Social Anxiety Scale, Self-report version (LSAS)
timeFrame: at 9-month post-treatment follow-up
Secondary outcomes:
measure: Patient Health Questionnaire-Depression Scale (PHQ-9)
timeFrame: through study completion, an average of 14 weeks
measure: Patient Health Questionnaire-Depression Scale (PHQ-9)
timeFrame: at 3-month post-treatment follow-up
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: through study completion, an average of 14 weeks
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: at 3-month post-treatment follow-up
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: through study completion, an average of 14 weeks
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: at 3-month post-treatment follow-up
measure: Social Phobia Weekly Summary Scale (SPWSS)
timeFrame: through study completion, an average of 14 weeks
measure: Social Phobia Weekly Summary Scale (SPWSS)
timeFrame: at 3-month post-treatment follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Patrick Leung, Prof.
role: PRINCIPAL_INVESTIGATOR
References: