CvC-SAD (Clinician vs Coach)Self-help Versions in a RCT

Official title

Chinese Internet-delivered Cognitive Therapy for Social Anxiety Disorder in Hong Kong: A Randomised Controlled Noninferiority Trial to Compare Clinician Versus Coach Guidance

Overview

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

• 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.

Primary outcome measures

• Liebowitz Social Anxiety Scale, Self-report version (LSAS) [Time frame: through study completion, an average of 14 weeks]
• Liebowitz Social Anxiety Scale, Self-report version (LSAS) [Time frame: at 3-month post-treatment follow-up]
• Liebowitz Social Anxiety Scale, Self-report version (LSAS) [Time frame: at 9-month post-treatment follow-up]

Secondary outcome measures (12)

• Patient Health Questionnaire-Depression Scale (PHQ-9) [Time frame: through study completion, an average of 14 weeks]
• Patient Health Questionnaire-Depression Scale (PHQ-9) [Time frame: at 3-month post-treatment follow-up]
• Patient Health Questionnaire-Depression Scale (PHQ-9) [Time frame: at 9-month post-treatment follow-up]
• Generalized Anxiety Disorder-7 (GAD-7) [Time frame: through study completion, an average of 14 weeks]
• Generalized Anxiety Disorder-7 (GAD-7) [Time frame: at 3-month post-treatment follow-up]
• Generalized Anxiety Disorder-7 (GAD-7) [Time frame: at 9-month post-treatment follow-up]
• Work and Social Adjustment Scale (WSAS) [Time frame: through study completion, an average of 14 weeks]
• Work and Social Adjustment Scale (WSAS) [Time frame: at 3-month post-treatment follow-up]
• Work and Social Adjustment Scale (WSAS) [Time frame: at 9-month post-treatment follow-up]
• Social Phobia Weekly Summary Scale (SPWSS) [Time frame: through study completion, an average of 14 weeks]
• Social Phobia Weekly Summary Scale (SPWSS) [Time frame: at 3-month post-treatment follow-up]
• Social Phobia Weekly Summary Scale (SPWSS) [Time frame: at 9-month post-treatment follow-up]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Chinese University of Hong Kong — Shatin

Identifiers

NCT: NCT05292612 · 2022.086-T

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗