Improving Social Anxiety Symptoms (SocWell)

NCT02451878 | Completed

• 2 other identifiers: MQ14PE_25Human Ethics Protocol 2015/229
• Study Type: interventional
• Target: 2,105
• Locations: 2 countries
• Sites: 2

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.

Conditions

Shyness; Wellbeing

Keywords

shyness; internet; self-help; psychology; wellbeing

Outcome Measures

Primary Outcomes (1)

• change in social anxiety symptoms (self-report using SPIN-17 measure)

  self-report social anxiety symptoms using SPIN-17 measure

  change from baseline to 6 weeks

Secondary Outcomes (7)

• mental wellbeing (self-report WEMWBS measure)

  6 weeks, 3 months, 6 months, 12 months

• depression (self-report CES-D measure)

  6 weeks, 3 months, 6 months, 12 months

• quality of life (using SF36 measure)

  6 weeks, 3 months, 6 months, 12 months

• use of health services (self-reported use of health services)- used for Health economic evaluation.

  12 months

• time off work or study (self-reported time off work or study)-Used for health economic evaluation.

  12 months

Study Arms (2)

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.

Behavioral: E-Couch

Control

NO INTERVENTION

Wait list control (WLC)

Interventions

E-Couch BEHAVIORAL

e-couch is an online CBT based intervention

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead
• Australian National University: collaborator

Study Sites (2)

National Institute for Mental Health Research, Australian National University

Canberra, Australian Capital Territory, 2601, Australia

Location

Nuffield Department of Primary Care Health Sciences, University of Oxford

Oxford, Oxfordshire, OX2 6GG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31821151 DERIVED

• 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.

  PMID: 29942591 DERIVED

MeSH Terms

Conditions

Shyness

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• John A Powell, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Kathleen M Griffiths, PhD

  Australian National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 22, 2015
• Study Start: May 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: July 15, 2019

Record last verified: 2018-07

Locations

AU (1); GB (1)