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NCT Number: NCT05292612

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

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).

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Shatin, Hong Kong

Location status: Recruiting

Location contact

PATRICK LEUNG

CONTACT

[email protected]

3943 6502

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

iCBT(C&W) for SAD

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.

Primary outcomes

  1. Liebowitz Social Anxiety Scale, Self-report version (LSAS)

    Time frame: 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.

  2. Liebowitz Social Anxiety Scale, Self-report version (LSAS)

    Time frame: at 3-month post-treatment follow-up

    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.

  3. Liebowitz Social Anxiety Scale, Self-report version (LSAS)

    Time frame: at 9-month post-treatment follow-up

    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 outcomes

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

    Time frame: 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

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

    Time frame: at 3-month post-treatment follow-up

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

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

    Time frame: at 9-month post-treatment follow-up

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

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

    Time frame: 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

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

    Time frame: at 3-month post-treatment follow-up

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

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

    Time frame: at 9-month post-treatment follow-up

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

  7. Work and Social Adjustment Scale (WSAS)

    Time frame: 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)

  8. Work and Social Adjustment Scale (WSAS)

    Time frame: at 3-month post-treatment follow-up

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

  9. Work and Social Adjustment Scale (WSAS)

    Time frame: at 9-month post-treatment follow-up

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

  10. Social Phobia Weekly Summary Scale (SPWSS)

    Time frame: 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.

  11. Social Phobia Weekly Summary Scale (SPWSS)

    Time frame: at 3-month post-treatment follow-up

    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.

  12. Social Phobia Weekly Summary Scale (SPWSS)

    Time frame: at 9-month post-treatment follow-up

    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.

  13. Behavioural social performance

    Time frame: at baseline

    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.

  14. Behavioural social performance

    Time frame: 1 week after completing the 14-week treatment

    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.

  15. Social Participation (SP)

    Time frame: At baseline

    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.

  16. Social Participation (SP)

    Time frame: week 8 of treatment

    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.

  17. Social Participation (SP)

    Time frame: 1 week after completing the 14-week treatment

    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.

  18. Social Participation (SP)

    Time frame: 3-month post-treatment follow-up

    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.

  19. Social Satisfaction (SS)

    Time frame: At baseline

    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.

  20. Social Satisfaction (SS)

    Time frame: week 8 of treatment

    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.

  21. Social Satisfaction (SS)

    Time frame: 1 week after completing the 14-week treatment

    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.

  22. Social Satisfaction (SS)

    Time frame: 3-month post-treatment follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Candace Ng

CONTACT

[email protected]

+85298046936

Patrick Leung, Prof.

CONTACT

[email protected]

+85239436502

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2022
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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