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

Primary Purpose

Social Anxiety Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iCBT(C&W) for SAD
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • DSM-5 criteria for SAD;
  • SAD problems lasting at least six months;
  • Participants considering SAD as their main problem;
  • Aged 18-65 (inclusive);
  • Not currently taking psychotropic mediation, or on a stable dose for at least two months without improvement, and willing to remain at this dosage throughout the trial;
  • Participants agreeing not to start any other forms of treatment (medication or psychological) during the trial;
  • Participants being Chinese residents of Hong Kong, with Chinese reading and writing proficiency at high-school level; and
  • Ready access to an internetconnected computer or mobile device.

Exclusion Criteria:

  • Having current or in the past psychosis, bipolar disorder, or borderline personality disorder;
  • Active suicidality;
  • Dependence on alcohol or substances;
  • Currently receiving psychological treatment; or
  • Having completed a course of CBT for SAD previously (≥5 sessions, including an exposure component).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Standard therapist-guided iCT-SAD vs. Waitlist

    Guided self-help iCT-SAD vs. Waitlist

    Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Patient Health Questionnaire-Depression Scale (PHQ-9)
    PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder
    Patient Health Questionnaire-Depression Scale (PHQ-9)
    PHQ-9 consists of nine items that captures the criterion symptoms of DSM-5 major depressive disorder
    Generalized Anxiety Disorder-7 (GAD-7)
    GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders
    Generalized Anxiety Disorder-7 (GAD-7)
    GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders
    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)
    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)
    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.
    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.

    Full Information

    First Posted
    February 23, 2022
    Last Updated
    January 12, 2023
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05292612
    Brief Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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: To develop and confirm the efficacy of a Chinese-language version of iCBT(C&W), administered by clinical psychologists in standard therapist-guided format. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Social Anxiety Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard therapist-guided iCT-SAD vs. Waitlist
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Guided self-help iCT-SAD vs. Waitlist
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    iCBT(C&W) for SAD
    Intervention Description
    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 Measure Information:
    Title
    Liebowitz Social Anxiety Scale, Self-report version (LSAS)
    Description
    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 weeks
    Title
    Liebowitz Social Anxiety Scale, Self-report version (LSAS)
    Description
    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-up
    Title
    Liebowitz Social Anxiety Scale, Self-report version (LSAS)
    Description
    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-up
    Secondary Outcome Measure Information:
    Title
    Patient Health Questionnaire-Depression Scale (PHQ-9)
    Description
    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 weeks
    Title
    Patient Health Questionnaire-Depression Scale (PHQ-9)
    Description
    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-up
    Title
    Generalized Anxiety Disorder-7 (GAD-7)
    Description
    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 weeks
    Title
    Generalized Anxiety Disorder-7 (GAD-7)
    Description
    GAD-7 consists of seven items that captures the criterion symptoms of DSM-5 common anxiety disorders
    Time Frame
    at 3-month post-treatment follow-up
    Title
    Work and Social Adjustment Scale (WSAS)
    Description
    WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD)
    Time Frame
    through study completion, an average of 14 weeks
    Title
    Work and Social Adjustment Scale (WSAS)
    Description
    WSAS consists of five items that measure participants' perceived functional impairment incurred by their presenting psychiatric problem (which, in this study, refers to SAD)
    Time Frame
    at 3-month post-treatment follow-up
    Title
    Social Phobia Weekly Summary Scale (SPWSS)
    Description
    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.
    Time Frame
    through study completion, an average of 14 weeks
    Title
    Social Phobia Weekly Summary Scale (SPWSS)
    Description
    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.
    Time Frame
    at 3-month post-treatment follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patrick Leung, Prof.
    Phone
    +85239436502
    Email
    pleung@cuhk.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Candace Ng
    Phone
    +85239197484
    Email
    nmy734@ha.org.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick Leung, Prof.
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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