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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02451878




Registration number
NCT02451878
Ethics application status
Date submitted
20/04/2015
Date registered
22/05/2015
Date last updated
15/07/2019

Titles & IDs
Public title
Improving Social Anxiety Symptoms (SocWell)
Scientific 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
Secondary ID [1] 0 0
Human Ethics Protocol 2015/229
Secondary ID [2] 0 0
MQ14PE_25
Universal Trial Number (UTN)
Trial acronym
SocWell
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shyness 0 0
Wellbeing 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - E-Couch

Experimental: Intervention - 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.

No intervention: Control - Wait list control (WLC)


BEHAVIORAL: E-Couch
e-couch is an online CBT based intervention
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
change in social anxiety symptoms (self-report using SPIN-17 measure)
Timepoint [1] 0 0
change from baseline to 6 weeks
Secondary outcome [1] 0 0
mental wellbeing (self-report WEMWBS measure)
Timepoint [1] 0 0
6 weeks, 3 months, 6 months, 12 months
Secondary outcome [2] 0 0
depression (self-report CES-D measure)
Timepoint [2] 0 0
6 weeks, 3 months, 6 months, 12 months
Secondary outcome [3] 0 0
quality of life (using SF36 measure)
Timepoint [3] 0 0
6 weeks, 3 months, 6 months, 12 months
Secondary outcome [4] 0 0
use of health services (self-reported use of health services)- used for Health economic evaluation.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
time off work or study (self-reported time off work or study)-Used for health economic evaluation.
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
social anxiety symptoms (fear of negative evaluation) (self-report using BFNE-S measure)
Timepoint [6] 0 0
6 weeks, 3 months, 6 months, 12 months
Secondary outcome [7] 0 0
social anxiety symptoms (self-report using SPIN-17 measure) at secondary time points
Timepoint [7] 0 0
3 months, 6 months, 12 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2018
Sample size
Target
Accrual to date
Final
2105
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
National Institute for Mental Health Research, Australian National University - Canberra
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Oxfordshire

Funding & Sponsors
Primary sponsor type
Other
Name
University of Oxford
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian National University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT02451878
Trial related presentations / 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.
Powell 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.
Public notes

Contacts
Principal investigator
Name 0 0
John A Powell, PhD
Address 0 0
University of Oxford
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02451878