Chinese Internet-delivered Cognitive Therapy for Social Anxiety Disorder in Hong Kong: A Randomised Controlled Noninferiority Trial to Compare Clinician Versus Coach Guidance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Liebowitz Social Anxiety Scale, Self-report version (LSAS)
研究概览
简要总结
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:
- To develop and confirm the efficacy of a Chinese-language version of iCBT(C&W), administered by clinical psychologists in standard therapist-guided format.
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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)
排除标准
- 未提供
研究组 & 干预措施
Standard therapist-guided iCT-SAD vs. Waitlist
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.
干预措施: iCBT(C&W) for SAD (Behavioral)
Guided self-help iCT-SAD vs. Waitlist
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.
干预措施: iCBT(C&W) for SAD (Behavioral)
Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD
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.
干预措施: iCBT(C&W) for SAD (Behavioral)
结局指标
主要结局
Liebowitz Social Anxiety Scale, Self-report version (LSAS)
时间窗: at 9-month post-treatment follow-up
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.
Liebowitz Social Anxiety Scale, Self-report version (LSAS)
时间窗: 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.
Liebowitz Social Anxiety Scale, Self-report version (LSAS)
时间窗: at 3-month post-treatment follow-up
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.
次要结局
- Patient Health Questionnaire-Depression Scale (PHQ-9)(at 3-month post-treatment follow-up)
- Generalized Anxiety Disorder-7 (GAD-7)(at 3-month post-treatment follow-up)
- Work and Social Adjustment Scale (WSAS)(at 3-month post-treatment follow-up)
- Social Phobia Weekly Summary Scale (SPWSS)(at 3-month post-treatment follow-up)
- Patient Health Questionnaire-Depression Scale (PHQ-9)(through study completion, an average of 14 weeks)
- Patient Health Questionnaire-Depression Scale (PHQ-9)(at 9-month post-treatment follow-up)
- Generalized Anxiety Disorder-7 (GAD-7)(through study completion, an average of 14 weeks)
- Generalized Anxiety Disorder-7 (GAD-7)(at 9-month post-treatment follow-up)
- Work and Social Adjustment Scale (WSAS)(through study completion, an average of 14 weeks)
- Work and Social Adjustment Scale (WSAS)(at 9-month post-treatment follow-up)
- Social Phobia Weekly Summary Scale (SPWSS)(through study completion, an average of 14 weeks)
- Social Phobia Weekly Summary Scale (SPWSS)(at 9-month post-treatment follow-up)
- Behavioural social performance(at baseline)
- Behavioural social performance(1 week after completing the 14-week treatment)
- Social Participation (SP)(At baseline)
- Social Participation (SP)(week 8 of treatment)
- Social Participation (SP)(1 week after completing the 14-week treatment)
- Social Participation (SP)(3-month post-treatment follow-up)
- Social Satisfaction (SS)(At baseline)
- Social Satisfaction (SS)(week 8 of treatment)
- Social Satisfaction (SS)(1 week after completing the 14-week treatment)
- Social Satisfaction (SS)(3-month post-treatment follow-up)
研究者
Prof. Patrick Wing-Leung LEUNG
Professor
Chinese University of Hong Kong