ICBT for SAD in Chinese Population: Therapist-guided Versus Coach-guided Self-help Versions in a RCT
Study Details
Study Description
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:
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To develop and confirm the efficacy of a Chinese-language version of iCBT(C&W), administered by clinical psychologists in standard therapist-guided format.
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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.
Design:
A two-arm parallel-group randomised controlled noninferiority trial, comparing the newly developed self-help format with the standard therapist-guided format.
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: therapist-guided iCBT participants would receive iCBT(C&W) for SAD under the guidance of trained therapists. |
Behavioral: iCBT(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.
|
| Experimental: coach-guided self-help participants would receive iCBT(C&W) for SAD under the guidance of trained coaches. |
Behavioral: iCBT(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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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DSM-5 criteria for SAD;
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SAD problems lasting at least six months;
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Participants considering SAD as their main problem;
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Aged 18-65 (inclusive);
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Not currently taking psychotropic mediation, or on a stable dose for at least two months without improvement, and willing to remain at this dosage throughout the trial;
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Participants agreeing not to start any other forms of treatment (medication or psychological) during the trial;
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Participants being Chinese residents of Hong Kong, with Chinese reading and writing proficiency at high-school level; and
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Ready access to an internetconnected computer or mobile device.
Exclusion Criteria:
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Having current or in the past psychosis, bipolar disorder, or borderline personality disorder;
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Active suicidality;
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Dependence on alcohol or substances;
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Currently receiving psychological treatment; or
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Having completed a course of CBT for SAD previously (≥5 sessions, including an exposure component).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chinese University of Hong Kong
Investigators
- Principal Investigator: Patrick Leung, Prof., Chinese University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NTEC-2021-0783