CvC-SAD (Clinician vs Coach)Self-help Versions in a RCT
ConditionSocial Anxiety Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorChinese University of Hong Kong
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
iCBT(C&W) for SAD
BehavioraliCBT(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.
Treatment groups
110 Participants
are divided into 3 treatment groupsGroup A: Standard therapist-guided iCT-SAD vs. WaitlistExperimental treatment 1 intervention
Group B: Guided self-help iCT-SAD vs. WaitlistExperimental treatment 1 intervention
Group C: Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SADExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, an average of 14 weeks2
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.
Time frame
at 3-month post-treatment follow-up3
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.
Time frame
at 9-month post-treatment follow-upSecondary outcomes
1
Patient Health Questionnaire-Depression Scale (PHQ-9)
PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder
Time frame
through study completion, an average of 14 weeks2
Patient Health Questionnaire-Depression Scale (PHQ-9)
PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder
Time frame
at 3-month post-treatment follow-up3
Patient Health Questionnaire-Depression Scale (PHQ-9)
PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder
Time frame
at 9-month post-treatment follow-up4
Generalized Anxiety Disorder-7 (GAD-7)
GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders
Time frame
through study completion, an average of 14 weeksSponsors and contacts
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Source ClinicalTrials.gov