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Improving Social Anxiety Symptoms (SocWell) (SocWell)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02451878
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Australian National University
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Shyness Wellbeing Behavioral: E-Couch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : May 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
Behavioral: E-Couch
e-couch is an online CBT based intervention

No Intervention: Control
Wait list control (WLC)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. mental wellbeing (self-report WEMWBS measure) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    mental wellbeing using self-report WEMWBS measure

  2. depression (self-report CES-D measure) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    depression using self-report CES-D measure

  3. quality of life (using SF36 measure) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    quality of life using SF36 measure

  4. use of health services (self-reported use of health services)- used for Health economic evaluation. [ Time Frame: 12 months ]
    self-reported use of health services in preceding 3 months

  5. time off work or study (self-reported time off work or study)-Used for health economic evaluation. [ Time Frame: 12 months ]
    self-reported time off work or study in preceding 3 months

  6. social anxiety symptoms (fear of negative evaluation) (self-report using BFNE-S measure) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    self-report using BFNE-S measure

  7. social anxiety symptoms (self-report using SPIN-17 measure) at secondary time points [ Time Frame: 3 months, 6 months, 12 months ]
    self-report social anxiety symptoms using SPIN-17 measure at secondary time points



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451878


Locations
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Australia, Australian Capital Territory
National Institute for Mental Health Research, Australian National University
Canberra, Australian Capital Territory, Australia, 2601
United Kingdom
Nuffield Department of Primary Care Health Sciences, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX2 6GG
Sponsors and Collaborators
University of Oxford
Australian National University
Investigators
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Principal Investigator: John A Powell, PhD University of Oxford
Principal Investigator: Kathleen M Griffiths, PhD Australian National University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02451878    
Other Study ID Numbers: MQ14PE_25
Human Ethics Protocol 2015/229 ( Other Identifier: Australian National University HREC )
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Oxford:
shyness
internet
self-help
psychology
wellbeing