Self-help internet tool for social anxiety symptoms

ISRCTN	ISRCTN15819951
DOI	https://doi.org/10.1186/ISRCTN15819951
ClinicalTrials.gov (NCT)	NCT02451878
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	University of Oxford
Funder	MQ: Transforming Mental Health

Submission date: 15/12/2015
Registration date: 21/01/2016
Last edited: 19/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Angela Martin
Scientific

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

Prof John Powell
Scientific

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

ORCID ID	0000-0002-1456-4857

Study information

Primary study design	Interventional
Study design	Pragmatic randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	SocWell
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/12/2018

Eligibility

Participant type(s)	All
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2104
Total final enrolment	2116
Key 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
Key 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
Date of first enrolment	01/02/2016
Date of final enrolment	31/07/2016

Locations

Countries of recruitment

United Kingdom
England

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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/01/2020	19/01/2021	Yes	No
Protocol article	protocol	10/04/2017	10/04/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/01/2021: Publication reference added.
29/05/2019: The following changes were made to the trial record:
1. The overall end date was changed from 01/03/2018 to 01/12/2018.
2. The total final enrolment was added.
3. The intention to publish date was changed from 31/12/2018 to 01/10/2019.
4. The plain English summary was corrected to accurately reflect the interventions.
5. The study design was changed from 'Pragmatic double-blind randomised controlled trial' to 'Pragmatic randomised controlled trial'
6. The condition was changed from “Sub-clinical social anxiety” to “Social anxiety symptoms”
7. The primary outcome measure was changed.
8. The secondary outcome measures were changed.
9. The participant exclusion criteria were changed.
10/04/2019: Publication reference added.