Social Anxiety Disorder
Conditions
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).
Interventions
BEHAVIORALiCBT(C&W) for SAD
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liebowitz Social Anxiety Scale, Self-report version (LSAS) | through study completion, an average of 14 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-Depression Scale (PHQ-9) | through study completion, an average of 14 weeks | PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder |
| Generalized Anxiety Disorder-7 (GAD-7) | through study completion, an average of 14 weeks | GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders |
| Work and Social Adjustment Scale (WSAS) | through study completion, an average of 14 weeks | WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD) |
| Social Phobia Weekly Summary Scale (SPWSS) | through study completion, an average of 14 weeks | SPWSS is a five-item self-report questionnaire on social anxiety, social avoidance, self-focused versus external-focused attention, anticipatory processing, and post-event rumination. |
| Behavioural social performance | at baseline | A behavioural assessment scheme, which includes the Simulated Social Interaction Test, unstructured conversation tasks and an impromptu speech, is adopted to measure social performance. Self-ratings of the behavioural scheme in skill and anxiety domains will be obtained by participants (self ratings) and observers (observer ratings). Ratings will be given in a 5-point Likert Scale. In the anxiety domain, 1 refers to the least anxiety while 5 refers to the most anxiety. In the skill domain, 1 refers to the worst skill and 5 refers to the best skill. Mean scores of the ratings will be calculated and used for analysis. |
| Social Participation (SP) | At baseline | Social Participation (SP) is a self-report questionnaire for evaluation of one's frequency of social participation from different social relationships. It is measured in a 7-point Likert Scale on the frequency of participation in 13 different social contexts where "1" refers to "never participated" and "7" refers to "always participated". The higher the score, the better the social functioning outcome. |
| Social Satisfaction (SS) | At baseline | Social Participation (SP) is a self-report questionnaire for evaluation of one's subjective satisfaction from 5 different social relationships where "1" refers to "the least satisfaction" and "7" refers to "the most satisfaction". The higher the score, the better the social functioning outcome. |
Countries
Hong Kong
Contacts
CONTACTPatrick Leung, Prof.
CONTACTCandace Ng
PRINCIPAL_INVESTIGATORPatrick Leung, Prof.
Chinese University of Hong Kong
Outcome results
None listed