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

NCT ID: NCT05292612

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-09-30

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:

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).

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

iCBT(C&W) for SAD

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

iCBT(C&W) for SAD

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

iCBT(C&W) for SAD

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Patrick Wing-Leung LEUNG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Leung, Prof.

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Central Contacts

Patrick Leung, Prof.

Role: CONTACT

pleung@cuhk.edu.hk

+85239436502

Candace Ng

Role: CONTACT

nmy734@ha.org.hk

+85239197484

Other Identifiers

2022.086-T

Identifier Type: -

Identifier Source: org_study_id