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, and again after 6-weeks (added 29/05/2019), 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
Study website
Contact information
Type
Scientific
Contact name
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
Contact name
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/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
NCT02451878
Protocol/serial number
Nil known
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(s)
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 randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Internet/virtual
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Social anxiety symptoms
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
Primary outcome measure
Current primary outcome measure as of 29/05/2019:
Change in self-reported social anxiety measured using the Social Phobia Inventory (SPIN) at 6 weeks.
Previous primary outcome measure:
Change in self-reported social anxiety measured using the Social Phobia Inventory (SPIN) at 6 weeks, 3, 6 and 12 months.
Secondary outcome measures
Current 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. Depression is measured using the Center for Epidemiologic Studies Depression Scale (CES-D) at 6 weeks, 3, 6 and 12 months
3. Mental wellbeing is measured using the Warwick-Edinburgh Mental Well-being scale (WEMWEBS) at 6 weeks, 3, 6 and 12 months
4. Quality of life is measured using the Short Form (36) Health Survey (SF36) at 6 weeks, 3, 6 and 12 months
5. Use of mental health services is measured using self-reported health service contact at 6 weeks, 3, 6 and 12 months
6. Safety events are measured using by monitoring participant feedback at 6 weeks, 3, 6 and 12 months
7. 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
Previous 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 study start date
01/06/2015
Overall study end date
01/12/2018
Reason abandoned (if study stopped)
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(s)
All
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
2104
Total final enrolment
2116
Participant exclusion criteria
Current participant exclusion criteria as of 29/05/2019:
1. Receiving therapist-guided treatment for social anxiety disorder
2. SPIN score <13
Previous 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
England, United Kingdom
Study 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
England
United Kingdom
+44 1865 270039
ctrg@admin.ox.ac.uk
Sponsor type
University/education
Website
ROR
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
01/10/2019
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/04/2017 | 10/04/2019 | Yes | No |
| Results article | results | 10/01/2020 | 19/01/2021 | Yes | No |