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Effectiveness and cost-effectiveness of a fully self-guided internet-based intervention for sub-clinical social anxiety symptoms : protocol for a randomised controlled trial
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Powell, John, Atherton, Helen, Williams, Veronika, Martin, Angela, Bennett, Kylie, Bennett, Anthony, Mollison, Jill, Yu, Ly-Mee, Yang, Yaling, Locock, Louise, Davoudianfar, Mina and Griffiths, Kathleen M (2017) Effectiveness and cost-effectiveness of a fully self-guided internet-based intervention for sub-clinical social anxiety symptoms : protocol for a randomised controlled trial. Digital Health, 3 . doi:10.1177/2055207617702272 ISSN 2055-2076.
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Official URL: http://dx.doi.org/10.1177/2055207617702272
Abstract
Design and objective:
This paper describes the protocol for a large-scale pragmatic, randomised controlled trial and economic evaluation to investigate the effectiveness and cost-effectiveness of the self-directed E-Couch social anxiety module versus a waiting list control condition, for reducing sub-clinical social anxiety symptoms in the general population.
Study population:
Community-based adults (aged 18+) with social anxiety symptoms that do not meet the criteria for social anxiety disorder recruited via a direct-to-consumer advertisement on national websites.
Intervention and control:
Intervention is the self-guided E-Couch social anxiety module. Control group participants are placed on a waiting list to receive the intervention at the end of the trial. Both groups receive email and text message reminders.
Outcome measures:
The primary outcome will be change in self-reported social anxiety score using the Social Phobia Inventory (SPIN). Secondary outcomes will be the changes in the following self-report measures: Brief Fear of Negative Evaluation scale (BFNE-S); depression (CES-D); mental wellbeing (SWEMWEBS); health status (SF36); use of health services; safety events; and adherence, retention, and attrition rates. All measures will be administered at baseline, 6 weeks, and 3, 6 and 12 months.
Analysis:
A mixed effects model will be used to analyse the effect of the intervention on the primary and secondary outcomes (intention to treat analysis). Secondary analyses will explore moderators and mediators of effect. A prospective economic evaluation, conducted from a NHS and social care perspective, will provide estimates of cost utility and cost-effectiveness. An interview study will be conducted with 20 participants to explore issues including acceptability, adherence, retention and attrition.
| Item Type: | Journal Article | ||||||||||||||||||
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| Subjects: | R Medicine > RC Internal medicine | ||||||||||||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Social Science & Systems in Health (SSSH) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Social phobia -- Treatment -- Cost effectiveness, Internet in medicine, Self-help techniques | ||||||||||||||||||
| Journal or Publication Title: | Digital Health | ||||||||||||||||||
| Publisher: | SAGE Publications Ltd. | ||||||||||||||||||
| ISSN: | 2055-2076 | ||||||||||||||||||
| Official Date: | 10 April 2017 | ||||||||||||||||||
| Dates: |
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| Volume: | 3 | ||||||||||||||||||
| DOI: | 10.1177/2055207617702272 | ||||||||||||||||||
| Status: | Peer Reviewed | ||||||||||||||||||
| Publication Status: | Published | ||||||||||||||||||
| Date of first compliant deposit: | 1 August 2017 | ||||||||||||||||||
| Date of first compliant Open Access: | 1 August 2017 | ||||||||||||||||||
| Funder: | MQ: Transforming Mental Health, National Health and Medical Research Council (Australia) (NHMRC) , Australia. Department of Health, National Institute for Health Research (Great Britain) (NIHR), Oxford Biomedical Research Centre | ||||||||||||||||||
| Grant number: | Fellowship 1059620 (NHMRC) | ||||||||||||||||||
| RIOXX Funder/Project Grant: |
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