Condition category
Mental and Behavioural Disorders
Date applied
16/10/2017
Date assigned
24/10/2017
Last edited
13/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Social Anxiety Disorder (SAD) is a marked and persistent fear of social situations and interactions, where people are fearful of saying or doing something that might lead to humiliation or rejection. It typically starts in childhood or adolescence, and without treatment, natural recovery is rare. As a result many people find their whole lives are affected, including educational achievement, work, social, and family functioning. Cognitive Therapy (CT) is a psychological therapy that helps people overcome their anxiety by understanding the thoughts, beliefs, and behaviours that are keeping it going. In the UK, individual CT based on the Clark and Wells (1995) model is a first-line recommended treatment for SAD according to the National Institute for Health and Care Excellence (NICE) guidelines. iCT-SAD is an online form of the Clark and Wells CT treatment, developed in the UK, where people work through a series of modules containing text, videos, and exercises to complete. They are supported by a therapist who they communicate with via messaging, telephone, and webcam. This study aims to assess whether the iCT-SAD intervention is effective when it is delivered in a different culture to where it was developed.

Who can participate?
English-speaking adults in Hong Kong who are experiencing social anxiety

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the iCT-SAD treatment, which lasts for 14 weeks, and a further 3-month follow-up period. Those in the second group receive the same treatment after a waiting period of 14 weeks. At the start, middle, end, and follow-up stages, all participants complete a range of questionnaires to assess their social anxiety and general wellbeing.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their social anxiety and general wellbeing because they are receiving psychological therapy. The risks of participating are minimal, although as with any therapy, participants will be discussing and working on situations they find difficult, which can at times cause some feelings of distress. They can share any concerns with their therapist who will support them.

Where is the study run from?
The study is being run in Hong Kong. It is a collaboration between the Chinese University of Hong Kong, University of Oxford, Hong Kong Hospital Authority, and the New Life Psychiatric Rehabilitation Association.

When is study starting and how long is it expected to run for?
September 2016 to December 2018

Who is funding the study?
1. Wellcome Trust (UK) [102176]
2. NIHR Biomedical Research Centre (UK)

Who is the main contact?
Dr Graham Thew
graham.thew@psy.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Graham Thew

ORCID ID

http://orcid.org/0000-0003-2851-1315

Contact details

Oxford Centre for Anxiety Disorders and Trauma (OxCADAT)
Department of Experimental Psychology
University of Oxford
The Old Rectory
Paradise Square
Oxford
OX1 1TW
United Kingdom
+44 (0)1865 618600
graham.thew@psy.ox.ac.uk

Type

Scientific

Additional contact

Prof Patrick Leung

ORCID ID

Contact details

Department of Psychology
The Chinese University of Hong Kong
3rd Floor
Sino Building
Shatin
N.T.
Hong Kong
Shatin
N.T.
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

iCT-SAD-HK_1.1

Study information

Scientific title

Internet-based cognitive therapy for social anxiety disorder in Hong Kong: a randomised controlled trial

Acronym

iCT-SAD-HK

Study hypothesis

The aim of the study is to investigate the hypothesis that iCT-SAD is superior to waitlist at reducing symptoms of SAD.

Ethics approval

1. Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee, 11/8/2017, ref: 2016.611-T
2. University of Oxford Tropical Research Ethics Committee, 31/08/2017, ref: 531-17

Study design

Single-centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Social anxiety disorder

Intervention

Participants will be recruited from the local population via advertisements in social and print media. Potential participants will be initially screened for eligibility using the social anxiety items of the Psychiatric Diagnostic Screening Questionnaire. Where respondents’ scores suggest they may meet criteria for SAD, they will be invited to attend an appointment to assess trial eligibility. If eligible, they will be randomised (stratification by social anxiety severity) to either the intervention or control arm.

iCT-SAD arm (intervention arm): iCT-SAD will be delivered on a 1:1 basis by one of three trained therapists using the online programme. The intervention lasts for 14 weeks, with the participant working through a series of online modules, with regular contact with their therapist via messaging, weekly telephone calls (15-20 minutes), and occasionally via webcam. The treatment is based on the Clark and Wells (1995) cognitive model of social anxiety. It aims to replicate the content and procedures of the face-to-face cognitive therapy (CT) protocol (see Clark et al., 2006), and is based around an individualised formulation. The iCT-SAD programme was developed by Clark and Ehlers’ research group, which is funded by the Wellcome Trust.

Waitlist (control arm): Those randomised to waitlist will begin the iCT-SAD intervention following a 14-week wait period.

The principal assessment points will be pretreatment/prewait, midtreatment/midwait, posttreatment/postwait, and three month follow up. Participants will complete a pack of self-report questionnaires assessing social anxiety and general wellbeing. At the posttreatment/postwait assessment, they will also complete a brief clinical interview with an independent assessor who is blinded to their group allocation. Adverse events/effects will be monitored throughout treatment and follow-up (phonecalls with therapist). Dropout, or premature termination from the study or treatment at any point after randomisation, will also be recorded along with reason for discontinuation or termination.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Severity of social anxiety, measured using the self-report version of the Liebowitz Social Anxiety Scale (Baker, Heinrichs, Kim, & Hofmann, 2002). The principal assessment points are pretreatment/prewait, midtreatment/midwait, posttreatment/postwait, and three month follow up.

Secondary outcome measures

1. Social anxiety, measured using:
1.1. Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5; Brown & Barlow, 2014). A clinical interview conducted by an independent assessor blind to treatment condition, at the posttreatment/postwait assessment point
1.2. Social Phobia Weekly Summary Scale (Clark, 1995)
1.3. Social Cognitions Questionnaire (Clark, 1995)
1.4. Social Phobia Inventory (Connor et al., 2000)
1.5. Social Behaviour Questionnaire (Clark, 1995)
1.6. Social Attitudes Questionnaire (Clark, 1995)
1.7. Fear of Negative Evaluation Scale (Watson & Friend, 1969)
1.8. Social Phobia Scale and Social Interaction Anxiety Scale (Mattick & Clarke, 1998)
1.9. Social Participation (Alden & Taylor, 2011)
1.10. Social Satisfaction (Alden & Taylor, 2011)
2.. Depression, measured using PHQ-9 (Kroencke, Spitzer, & Williams, 2001)
3. Generalised anxiety, measured using GAD-7 (Spitzer, Kroenke, Williams, & Löwe, 2006)
4. General functioning, measured using Work and Social Adjustment Scale (Mundt, Marks, Shear, & Greist, 2002)
5. Generalised learning, measured using Generalised Learning Questionnaire (in development)
The principal assessment points are pretreatment/prewait, midtreatment/midwait, posttreatment/postwait, and three month follow up.

Overall trial start date

26/09/2016

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Meets DSM-5 criteria for SAD
2. Social anxiety problem has lasted at least six months
3. Participant considers SAD to be their main problem
4. Age 18-65 (inclusive)
5. Not currently taking psychotropic mediation, or on a stable dose for at least two months without improvement, and willing to remain at this dose throughout trial
6. Participant agrees not to start any other forms of treatment (medication or psychological) during the trial
7. Participant is a Chinese resident of Hong Kong, with sufficient proficiency in English to understand the treatment content
8. Regular access to an internet-connected computer or mobile device

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Current or past psychosis, bipolar disorder, or borderline personality disorder
2. Active suicidality
3. Dependence on alcohol or substances
4. Currently receiving psychological treatment
5. Having completed a course of CBT for social anxiety previously (defined as at least 5 sessions, and including an exposure component)

Recruitment start date

01/11/2017

Recruitment end date

30/04/2018

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Chinese University of Hong Kong
Department of Psychology 3rd Floor, Sino Building, Shatin, N.T.
Hong Kong
Shatin, N.T.
Hong Kong

Sponsor information

Organisation

Chinese University of Hong Kong

Sponsor details

Shatin
NT
Hong Kong
Shatin
NT
Hong Kong SAR
Hong Kong

Sponsor type

University/education

Website

http://www.cuhk.edu.hk/english/index.html

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Funder name

National Institute for Health Research - Biomedical Research Centre (Oxford)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Additional study documents are available on request. Planned publication of the findings in a peer reviewed journal following the conclusion of the study.

IPD sharing statement
Requests for data sharing as part of research collaborations will be considered after the primary trial analyses have been published. Researchers should contact Dr Graham Thew in the first instance (graham.thew@psy.ox.ac.uk).

Intention to publish date

01/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/03/2018: The recruitment end date has been changed from 28/02/2018 to 30/04/2018.