Condition category
Mental and Behavioural Disorders
Date applied
15/12/2015
Date assigned
21/01/2016
Last edited
21/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Social anxiety disorder, also known as social phobia, is a common type of anxiety disorders, in which a person feels a persistent and overwhelming fear of social situations. The symptoms can range from very mild to so severe that it causes major problems in day-to-day life. The problems tend to last for years and people often do not seek help. Seeing a therapist for face-to-face cognitive behavioural therapy is recommended by NICE as the most effective approach for social anxiety disorder. Some people are said to have 'sub-clinical' social anxiety symptoms, which cause them problems but are not severe enough to be diagnosed as 'social anxiety disorder'. Many of these people turn to the internet to look for help and there is a wide range of unguided self-help tools available, however there is very little evidence to say whether or not these are actually helpful. The aim of this study is to find out whether a specific web-based training programme can help people with sub-clinical social anxiety symptoms in the general population to feel more comfortable in social situations.

Who can participate?
Adults living in England who are suffering from social anxiety symptoms.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group are asked to complete the social anxiety module which includes elements of cognitive behavioural therapy (teaching ways of changing behaviour) and face-to-face talking therapy. Participants in the second group are placed on a waiting list, and so do not receive access to the social anxiety module throughout the study. At the start of the study, an again after 3, 6 and 12 months, participants in both groups complete a number of questionnaires in order to measure their levels of anxiety.

What are the possible benefits and risks of participating?
Participants benefit from receiving treatment that they would not otherwise have access to (in the form of the online module), which could be an effective treatment for their anxiety. There are no significant risks of taking part however the online module could cause distress to some participants.

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
June 2015 to March 2018

Who is funding the study?
MQ: Transforming Mental Health (UK)

Who is the main contact?
Mrs Angela Martin

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Angela Martin

ORCID ID

Contact details

Health Experiences Research Group
University of Oxford
Nuffield Department of Primary Care Health Sciences (Gibson Building)
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

Type

Scientific

Additional contact

Prof John Powell

ORCID ID

http://orcid.org/0000-0002-1456-4857

Contact details

Health Experiences Research Group
University of Oxford
Nuffield Department of Primary Care Health Sciences (Gibson Building)
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02451878

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness and cost-effectiveness of a fully self-guided internet-based intervention for sub-clinical social anxiety symptoms: pragmatic, population-based randomised controlled trial

Acronym

SocWell

Study hypothesis

A fully self-guided internet based self-help intervention for sub-clinical social anxiety symptoms in the general population is effective in reducing social anxiety symptoms.

Ethics approval

1. Medical Sciences Inter-Divisional Research Ethics Committee (University of Oxford), 26/08/2015, ref: MS-IDREC-C1-2015-167
2. Human Ethics committee (ANU), 04/06/2015, ref: 2015/229

Study design

Pragmatic double-blind 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 below to request a patient information sheet.

Condition

Sub-clinical social anxiety

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: will be asked to complete an online social anxiety module (https://ecouch.anu.edu.au), which is based on cognitive behavioural therapy principles and includes components of known effectiveness in face-to-face therapy. 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.

Control group: Participants are placed on a "waiting list" to receive the intervention, and do not receive any additional treatment for the duration of the study.

Both groups will be asked to complete outcome measure and self-reported use of services at baseline, 6 weeks, 3 months, 6 months and 12 months. Around 20 participants from the intervention arm will be asked to take part in a one off interview at the end of the study, to explore their experience of the intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in self-reported social anxiety measured using the Social Phobia Inventory (SPIN) at 6 weeks, 3, 6 and 12 months.

Secondary outcome measures

1. Fear of negative evaluation is measured using the Brief Fear of Negative Evaluation scale (8 item BFNE-S) at 6 weeks, 3, 6 and 12 months
2. Social anxiety symptoms are is measured using the SOPHS Social Phobia screener at 6 weeks, 3, 6 and 12 months
3. Anxiety is measured using the GAD7 Anxiety Test Questionnaire at 6 weeks, 3, 6 and 12 months
4. Depression is measured using the Center for Epidemiologic Studies Depression Scale (CES-D) at 6 weeks, 3, 6 and 12 months
5. Mental wellbeing is measured using the Warwick-Edinburgh Mental Well-being scale (WEMWEBS) at 6 weeks, 3, 6 and 12 months
6. Quality of life is measured using the Short Form (36) Health Survey (SF36) at 6 weeks, 3, 6 and 12 months
7. Use of mental health services is measured using self-reported health service contact at 6 weeks, 3, 6 and 12 months
8. Safety events are measured using by monitoring participant feedback at 6 weeks, 3, 6 and 12 months
9. Adherence, retention and attrition rates are measured by recording and monitoring usage data and number of components of e-couch completed at 6 weeks, 3, 6 and 12 months

Overall trial start date

01/06/2015

Overall trial end date

01/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Resident of England
3. Willing to provide a working e-mail address and mobile phone number
4. Suffering from social anxiety symptoms

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

2104

Participant exclusion criteria

1. Receiving therapist-guided treatment for social anxiety disorder
2. SPIN score <13
3. SPIN score >19

Recruitment start date

01/02/2016

Recruitment end date

31/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Primary Care Clinical Trials Unit Nuffield Department of Primary Care Health Sciences (Gibson Building) Radcliffe Observatory Quarter Woodstock Road
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

University Offices
Wellington Square
Oxford
OX2 6GG
United Kingdom
+44 1865 270039
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

MQ: Transforming Mental Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication of results in peer-reviewed publications (open access where possible).
2. Presentation of results at conferences presentations
3. A full report will be disseminated to the funder (MQ)
4. Summaries of each output will be produced for lay, policy and practitioner audiences
5. Findings will be shared on social media and through press releases (in conjunction with MQ)
6. Findings will be presented at a final workshop targeting key audiences including patients, public and their representatives

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes