Improving Social Anxiety Symptoms (SocWell)

Wellbeing Clinical Trial

— SocWell  

Official title:

Effectiveness and Cost-effectiveness of a Fully Self-guided Internet-based Intervention for Shyness and Sub-clinical Social Anxiety Symptoms in the General Population: Pragmatic Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451878
• Other study ID #: MQ14PE_25
• Secondary ID: Human Ethics Pro
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will test the value of an internet self-help package (E-Couch) for alleviating social anxiety symptoms in the general population. The investigators will undertake a trial of about 2000 participants to compare the effect of the E-Couch intervention compared to a wait-list control condition. Over a period of 12 months the investigators will measure the effect of using E-Couch self-help on social anxiety symptoms, as well as on mental wellbeing, and other secondary outcomes including quality of life, depression and general anxiety, and their use of other sources of help.

Description:

DESIGN The study will involve a large, pragmatic, randomised controlled trial of the internet-based self-directed E-Couch social anxiety module versus a wait-list control condition for the reduction of sub-clinical social anxiety symptoms, among a general population sample recruited using direct-to-consumer advertisements on national websites.

RECRUITMENT Participants in this study will be recruited using advertisements placed on websites such as the NHS website. Individuals expressing an interest in the online advertisement by clicking on a web link will be directed to a University website containing full information on the trial and the opportunity to ask questions of the study team by email or telephone. Participants will be advised in the information sheet that they are free to withdraw at any time without giving a reason and without it affecting their care.

CONSENT Interested participants will be asked to indicate their willingness to participate in the screening and/or the trial by clicking on Yes in response to the online consent questions.

SCREENING Users who provide their consent will be invited to complete screening questions which will determine whether they are eligible for participation in the trial.

INCLUSION AND EXCLUSION Inclusion criteria for this trial include age 18 years and over, resident of England and a score of 13 or more on the SPIN social anxiety measure, and a willingness to provide a working email address and mobile phone number (to respond to a confirmation email and receive reminders). People who are currently receiving therapist-guided treatment for social anxiety disorder will be excluded from participation as will those with a self-reported diagnosis of bipolar disorder or schizophrenia.

MEASURES Following completion of the screening survey eligible participants will be advised that they are eligible to participate in the trial and asked to provide their email address and mobile phone number. Once these details have been submitted they will be advised that in 24 hours they will receive an e-mail providing a link to an online baseline survey. The e-mail will link to a battery of demographic and self-report mental health measures. Measures will be taken at baseline and, for those randomised, at all or most of the follow up points including post-intervention, 3-, 6- and 12-months. At each follow-up point both Intervention and Control participants will receive notification of follow-up measures by email and by text message.

RANDOMISATION Participants who complete baseline measures within one week of receiving the survey link via email, will be randomised using an automated computer algorithm to the E-Couch social anxiety tool (Intervention) or to a Wait list control condition. Participants will be advised of the condition to which they have been allocated.

ACCESS TO INTERVENTION Intervention participants will be asked to set a password associated with their email address, and provided with access to the Intervention. Intervention participants will be encouraged to access and use the self-guided intervention over a period of up to 6 weeks (although they can chose to work through the program at their own pace). Access will be via secure login on the research trial website, using their email address and password.

INTERVENTION The E-Couch social anxiety module which is based on cognitive behavioural therapy principles. This module contains a literacy section and 5 toolkits comprising exposure practice, cognitive restructuring (modifying your thinking), attention practice, social skills training and relaxation. E-Couch is designed to be completed at the participant's own pace. It is free to use, browser-based and widely accessible on a range of connected devices.

CONTROL The Control group will be placed on a wait list to receive the intervention in 12 months.

RISKS The risks to the participants are likely to be minimal. The study uses standard well-tested measures or tools modified from these measures. Participants are referred to a source of help in the Information Sheet in case of distress. The intervention has been employed without problems in publically accessible form across the world since 2008.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2105
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 or over

• Resident in England

• Willing to provide email address and mobile telephone number

• Able to use a web-based intervention provided in written English

• SPIN score 13 or more (to include those with subclinical symptoms)

Exclusion Criteria:

• Aged under 18

• Not resident in England

• Unwilling or unable to provide email address and mobile telephone number

• Unable to use a web-based intervention provided in written English

• SPIN score <13

• Self-reported history of psychosis (schizophrenia or bipolar affective disorder)

• Receiving therapist-guided support for social anxiety disorder (self-reported)

Related Conditions & MeSH terms

• Shyness
• Wellbeing

Intervention

Behavioral:
• E-Couch
e-couch is an online CBT based intervention

Locations

Country	Name	City	State
Australia	National Institute for Mental Health Research, Australian National University	Canberra	Australian Capital Territory
United Kingdom	Nuffield Department of Primary Care Health Sciences, University of Oxford	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Australian National University

Countries where clinical trial is conducted

Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in social anxiety symptoms (self-report using SPIN-17 measure)	self-report social anxiety symptoms using SPIN-17 measure	change from baseline to 6 weeks
Secondary	mental wellbeing (self-report WEMWBS measure)	mental wellbeing using self-report WEMWBS measure	6 weeks, 3 months, 6 months, 12 months
Secondary	depression (self-report CES-D measure)	depression using self-report CES-D measure	6 weeks, 3 months, 6 months, 12 months
Secondary	quality of life (using SF36 measure)	quality of life using SF36 measure	6 weeks, 3 months, 6 months, 12 months
Secondary	use of health services (self-reported use of health services)- used for Health economic evaluation.	self-reported use of health services in preceding 3 months	12 months
Secondary	time off work or study (self-reported time off work or study)-Used for health economic evaluation.	self-reported time off work or study in preceding 3 months	12 months
Secondary	social anxiety symptoms (fear of negative evaluation) (self-report using BFNE-S measure)	self-report using BFNE-S measure	6 weeks, 3 months, 6 months, 12 months
Secondary	social anxiety symptoms (self-report using SPIN-17 measure) at secondary time points	self-report social anxiety symptoms using SPIN-17 measure at secondary time points	3 months, 6 months, 12 months