ShynessSocWellNCT02451878
Improving Social Anxiety Symptoms (SocWell)
A study testing E-Couch in people with Shyness and Wellbeing, run by University of Oxford at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- E-Couch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,105 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
National Institute for Mental Health Research, Australian National University
Canberra, Australian Capital Territory, 2601
United Kingdom1 site
Nuffield Department of Primary Care Health Sciences, University of Oxford
Oxford, Oxfordshire, OX2 6GG
About this study
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
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.
Read the detailed 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.
- Being tested
- E-Couch
- Keywords
- shyness, internet, self-help, psychology, wellbeing
- Medical subject headings
- Shyness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CouchBehavioural
e-couch is an online CBT based intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The E-Couch self-help 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. Receives: Behavioral: E-Couch |
| Control | No intervention | Wait list control (WLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in social anxiety symptoms (self-report using SPIN-17 measure)
self-report social anxiety symptoms using SPIN-17 measure
Measured: change from baseline to 6 weeks
Secondary outcomes (7)
mental wellbeing (self-report WEMWBS measure)
mental wellbeing using self-report WEMWBS measure
Measured: 6 weeks, 3 months, 6 months, 12 months
depression (self-report CES-D measure)
depression using self-report CES-D measure
Measured: 6 weeks, 3 months, 6 months, 12 months
quality of life (using SF36 measure)
quality of life using SF36 measure
Measured: 6 weeks, 3 months, 6 months, 12 months
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
Measured: 12 months
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
Measured: 12 months
social anxiety symptoms (fear of negative evaluation) (self-report using BFNE-S measure)
self-report using BFNE-S measure
Measured: 6 weeks, 3 months, 6 months, 12 months
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
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMay 2015
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ShynessStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Australian National University
- Responsible party
- Sponsor
- Investigators
- John A Powell, PhD, Principal investigator, University of OxfordKathleen M Griffiths, PhD, Principal investigator, Australian National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451878
- Sponsor's protocol ID
- MQ14PE_25
- Other IDs
- Human Ethics Protocol 2015/229
- Acronym
- SocWell
- Status last verified
- Jul 2018
- First submitted
- 20 Apr 2015
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Powell J, Williams V, Atherton H, Bennett K, Yang Y, Davoudianfar M, Hellsing A, Martin A, Mollison J, Shanyinde M, Yu LM, Griffiths KM. Effectiveness and Cost-Effectiveness of a Self-Guided Internet Intervention for Social Anxiety Symptoms in a General Population Sample: Randomized Controlled Trial. J Med Internet Res. 2020 Jan 10;22(1):e16804. doi: 10.2196/16804.
PubMed 31821151Powell J, Atherton H, Williams V, Martin A, Bennett K, Bennett A, Mollison J, Yu LM, Yang Y, Locock L, Davoudianfar M, Griffiths KM. Effectiveness and cost-effectiveness of a fully self-guided internet-based intervention for sub-clinical social anxiety symptoms: Protocol for a randomised controlled trial. Digit Health. 2017 Apr 10;3:2055207617702272. doi: 10.1177/2055207617702272. eCollection 2017 Jan-Dec.
PubMed 29942591
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02451878
- Acronym / sponsor ID
- SocWell / MQ14PE_25
- Keywords
- shyness, internet, self-help, psychology, wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,105 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Australian National University
- Study start
- May 2015
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: E-CouchThe E-Couch self-help 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 | No intervention | –Wait list control (WLC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-Couche-couch is an online CBT based intervention | Behavioural | Intervention |
Primary outcome
change in social anxiety symptoms (self-report using SPIN-17 measure)
Time frame: change from baseline to 6 weeks
self-report social anxiety symptoms using SPIN-17 measure
7 secondary outcomes
mental wellbeing (self-report WEMWBS measure)
Time frame: 6 weeks, 3 months, 6 months, 12 months
depression (self-report CES-D measure)
Time frame: 6 weeks, 3 months, 6 months, 12 months
quality of life (using SF36 measure)
Time frame: 6 weeks, 3 months, 6 months, 12 months
use of health services (self-reported use of health services)- used for Health economic evaluation.
Time frame: 12 months
time off work or study (self-reported time off work or study)-Used for health economic evaluation.
Time frame: 12 months
social anxiety symptoms (fear of negative evaluation) (self-report using BFNE-S measure)
Time frame: 6 weeks, 3 months, 6 months, 12 months
social anxiety symptoms (self-report using SPIN-17 measure) at secondary time points
Time frame: 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Derived from this study: PubMed 31821151Powell J, Williams V, Atherton H, Bennett K, Yang Y, Davoudianfar M, Hellsing A, Martin A, Mollison J, Shanyinde M, Yu LM, Griffiths KM. Effectiveness and Cost-Effectiveness of a Self-Guided Internet Intervention for Social Anxiety Symptoms in a General Population Sample: Randomized Controlled Trial. J Med Internet Res. 2020 Jan 10;22(1):e16804. doi: 10.2196/16804.
- Derived from this study: PubMed 29942591Powell J, Atherton H, Williams V, Martin A, Bennett K, Bennett A, Mollison J, Yu LM, Yang Y, Locock L, Davoudianfar M, Griffiths KM. Effectiveness and cost-effectiveness of a fully self-guided internet-based intervention for sub-clinical social anxiety symptoms: Protocol for a randomised controlled trial. Digit Health. 2017 Apr 10;3:2055207617702272. doi: 10.1177/2055207617702272. eCollection 2017 Jan-Dec.
- Individual participant dataSharing planned: Undecided
Related trials for Shyness
Active, not recruiting
Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Anxiety Disorder of Childhood, Fear
Recruiting
Learn to Dare! Leiden
Childhood Anxiety, Shyness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Powell, PhD principal investigator
University of Oxford
Kathleen M Griffiths, PhD principal investigator
Australian National University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Couch in people with Shyness and Wellbeing, run by University of Oxford at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in social anxiety symptoms (self-report using SPIN-17 measure) (time frame: change from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451878, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.