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Social Anxiety DisorderNCT05292612

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

A study testing iCBT(C&W) for SAD in people with Social Anxiety Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Social Anxiety Disorder
What is being tested?
iCBT(C&W) for SAD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteHong Kong
Study dates
1 May 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patrick Leung, Prof. contact

+85239436502

pleung@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • The Chinese University of Hong Kong

    Shatin

    PATRICK LEUNG, 3943 6502, pleung@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

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

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.

Read more

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).

Being tested
iCBT(C&W) for SAD
Medical subject headings
Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCBT(C&W) for SADBehavioural

    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.

Study groups in NCT05292612
Study groupRoleWhat they receive
Standard therapist-guided iCT-SAD vs. WaitlistExperimentalto 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.
Receives: Behavioral: iCBT(C&W) for SAD
Guided self-help iCT-SAD vs. WaitlistExperimentalto 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.
Receives: Behavioral: iCBT(C&W) for SAD
Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SADExperimentalto 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.
Receives: Behavioral: iCBT(C&W) for SAD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 14 weeks

  2. 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.

    Measured: at 3-month post-treatment follow-up

  3. 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.

    Measured: at 9-month post-treatment follow-up

Secondary outcomes (22)
  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

    Measured: through study completion, an average of 14 weeks

  2. Patient Health Questionnaire-Depression Scale (PHQ-9)

    PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder

    Measured: at 3-month post-treatment follow-up

  3. Patient Health Questionnaire-Depression Scale (PHQ-9)

    PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder

    Measured: at 9-month post-treatment follow-up

  4. Generalized Anxiety Disorder-7 (GAD-7)

    GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders

    Measured: through study completion, an average of 14 weeks

  5. Generalized Anxiety Disorder-7 (GAD-7)

    GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders

    Measured: at 3-month post-treatment follow-up

  6. Generalized Anxiety Disorder-7 (GAD-7)

    GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders

    Measured: at 9-month post-treatment follow-up

  7. Work and Social Adjustment Scale (WSAS)

    WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD)

    Measured: through study completion, an average of 14 weeks

  8. Work and Social Adjustment Scale (WSAS)

    WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD)

    Measured: at 3-month post-treatment follow-up

  9. Work and Social Adjustment Scale (WSAS)

    WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD)

    Measured: at 9-month post-treatment follow-up

  10. Social Phobia Weekly Summary Scale (SPWSS)

    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.

    Measured: through study completion, an average of 14 weeks

  11. Social Phobia Weekly Summary Scale (SPWSS)

    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.

    Measured: at 3-month post-treatment follow-up

  12. Social Phobia Weekly Summary Scale (SPWSS)

    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.

    Measured: at 9-month post-treatment follow-up

  13. Behavioural social performance

    A behavioural assessment scheme, which includes the Simulated Social Interaction Test, unstructured conversation tasks and an impromptu speech, is adopted to measure social performance. Self-ratings of the behavioural scheme in skill and anxiety domains will be obtained by participants (self ratings) and observers (observer ratings). Ratings will be given in a 5-point Likert Scale. In the anxiety domain, 1 refers to the least anxiety while 5 refers to the most anxiety. In the skill domain, 1 refers to the worst skill and 5 refers to the best skill. Mean scores of the ratings will be calculated and used for analysis.

    Measured: at baseline

  14. Behavioural social performance

    A behavioural assessment scheme, which includes the Simulated Social Interaction Test, unstructured conversation tasks and an impromptu speech, is adopted to measure social performance. Self-ratings of the behavioural scheme in skill and anxiety domains will be obtained by participants (self ratings) and observers (observer ratings). Ratings will be given in a 5-point Likert Scale. In the anxiety domain, 1 refers to the least anxiety while 5 refers to the most anxiety. In the skill domain, 1 refers to the worst skill and 5 refers to the best skill. Mean scores of the ratings will be calculated and used for analysis.

    Measured: 1 week after completing the 14-week treatment

  15. Social Participation (SP)

    Social Participation (SP) is a self-report questionnaire for evaluation of one's frequency of social participation from different social relationships. It is measured in a 7-point Likert Scale on the frequency of participation in 13 different social contexts where "1" refers to "never participated" and "7" refers to "always participated". The higher the score, the better the social functioning outcome.

    Measured: At baseline

  16. Social Participation (SP)

    Social Participation (SP) is a self-report questionnaire for evaluation of one's frequency of social participation from different social relationships. It is measured in a 7-point Likert Scale on the frequency of participation in 13 different social contexts where "1" refers to "never participated" and "7" refers to "always participated". The higher the score, the better the social functioning outcome.

    Measured: week 8 of treatment

  17. Social Participation (SP)

    Social Participation (SP) is a self-report questionnaire for evaluation of one's frequency of social participation from different social relationships. It is measured in a 7-point Likert Scale on the frequency of participation in 13 different social contexts where "1" refers to "never participated" and "7" refers to "always participated". The higher the score, the better the social functioning outcome.

    Measured: 1 week after completing the 14-week treatment

  18. Social Participation (SP)

    Social Participation (SP) is a self-report questionnaire for evaluation of one's frequency of social participation from different social relationships. It is measured in a 7-point Likert Scale on the frequency of participation in 13 different social contexts where "1" refers to "never participated" and "7" refers to "always participated". The higher the score, the better the social functioning outcome.

    Measured: 3-month post-treatment follow-up

  19. Social Satisfaction (SS)

    Social Participation (SP) is a self-report questionnaire for evaluation of one's subjective satisfaction from 5 different social relationships where "1" refers to "the least satisfaction" and "7" refers to "the most satisfaction". The higher the score, the better the social functioning outcome.

    Measured: At baseline

  20. Social Satisfaction (SS)

    Social Participation (SP) is a self-report questionnaire for evaluation of one's subjective satisfaction from 5 different social relationships where "1" refers to "the least satisfaction" and "7" refers to "the most satisfaction". The higher the score, the better the social functioning outcome.

    Measured: week 8 of treatment

  21. Social Satisfaction (SS)

    Social Participation (SP) is a self-report questionnaire for evaluation of one's subjective satisfaction from 5 different social relationships where "1" refers to "the least satisfaction" and "7" refers to "the most satisfaction". The higher the score, the better the social functioning outcome.

    Measured: 1 week after completing the 14-week treatment

  22. Social Satisfaction (SS)

    Social Participation (SP) is a self-report questionnaire for evaluation of one's subjective satisfaction from 5 different social relationships where "1" refers to "the least satisfaction" and "7" refers to "the most satisfaction". The higher the score, the better the social functioning outcome.

    Measured: 3-month post-treatment follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2022
  2. Study start1 May 2023
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292612
Sponsor's protocol ID
2022.086-T
Status last verified
Feb 2026
First submitted
23 Feb 2022
Last updated
18 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing iCBT(C&W) for SAD in people with Social Anxiety Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patrick Leung, Prof. (+85239436502, pleung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liebowitz Social Anxiety Scale, Self-report version (LSAS) (time frame: through study completion, an average of 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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