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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapist-guided iCT-SAD vs. Waitlist | Experimental | to examine if standard iCT-SAD delivered in Chinese is superior to waitlist. participants in the experimental group would receive iCBT(C&W) for SAD under the guidance of trained therapist. |
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| Guided self-help iCT-SAD vs. Waitlist | Experimental | to examine if guided self-help iCT-SAD delivered in Chinese is superior to waitlist. participants in the experimental group would receive iCBT(C&W) for SAD under the guidance of trained coaches. |
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| Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD | Experimental | to examine if guided self-help iCT-SAD is noninferior to standard iCT-SAD. participants would be randomised into two groups. one group of participants would receive iCBT(C&W) for SAD under the guidance of trained therapist while the other group of participants would receive iCBT(C&W) for SAD under the guidance of trained coaches. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCBT(C&W) for SAD | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Liebowitz Social Anxiety Scale, Self-report version (LSAS) | 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. | through study completion, an average of 14 weeks |
| Liebowitz Social Anxiety Scale, Self-report version (LSAS) | 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. | at 3-month post-treatment follow-up |
| Liebowitz Social Anxiety Scale, Self-report version (LSAS) | 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. | at 9-month post-treatment follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-Depression Scale (PHQ-9) | PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder | through study completion, an average of 14 weeks |
| Patient Health Questionnaire-Depression Scale (PHQ-9) |
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Inclusion
Exclusion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Leung, Prof. | Contact | +85239436502 | pleung@cuhk.edu.hk | |
| Candace Ng | Contact | +85298046936 | candace.ng@ha.org.hk |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Leung, Prof. | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Recruiting | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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|
PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder |
| at 3-month post-treatment follow-up |
| Patient Health Questionnaire-Depression Scale (PHQ-9) | PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder | at 9-month post-treatment follow-up |
| Generalized Anxiety Disorder-7 (GAD-7) | GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders | through study completion, an average of 14 weeks |
| Generalized Anxiety Disorder-7 (GAD-7) | GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders | at 3-month post-treatment follow-up |
| Generalized Anxiety Disorder-7 (GAD-7) | GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders | at 9-month post-treatment follow-up |
| Work and Social Adjustment Scale (WSAS) | WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD) | through study completion, an average of 14 weeks |
| Work and Social Adjustment Scale (WSAS) | WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD) | at 3-month post-treatment follow-up |
| Work and Social Adjustment Scale (WSAS) | WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD) | at 9-month post-treatment follow-up |
| Social Phobia Weekly Summary Scale (SPWSS) | 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. | through study completion, an average of 14 weeks |
| Social Phobia Weekly Summary Scale (SPWSS) | 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. | at 3-month post-treatment follow-up |
| Social Phobia Weekly Summary Scale (SPWSS) | 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. | at 9-month post-treatment follow-up |
| Behavioural social performance | 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. | at baseline |
| Behavioural social performance | 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. | 1 week after completing the 14-week treatment |
| Social Participation (SP) | 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. | At baseline |
| Social Participation (SP) | 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. | week 8 of treatment |
| Social Participation (SP) | 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. | 1 week after completing the 14-week treatment |
| Social Participation (SP) | 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. | 3-month post-treatment follow-up |
| Social Satisfaction (SS) | 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. | At baseline |
| Social Satisfaction (SS) | 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. | week 8 of treatment |
| Social Satisfaction (SS) | 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. | 1 week after completing the 14-week treatment |
| Social Satisfaction (SS) | 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. | 3-month post-treatment follow-up |