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Trial registered on ANZCTR

Registration number

ACTRN12609001082291

Ethics application status

Approved

Date submitted

17/12/2009

Date registered

17/12/2009

Date last updated

2/12/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Shyness 7: Self-guided Internet based education for social phobia with or without motivational strategies. A randomized controlled study

Scientific title

A randomized controlled trial of self-guided Internet based education for social phobia comparing motivational strategies vs. no motivational strategies on severity of symptoms of social phobia.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Social phobia (an anxiety disorder)

Condition category

Condition code

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be randomly assigned to one of two groups: 1) Self-guided Internet based education for social phobia with written exercises to promote motivation (motivational strategies) with automatic email reminders, or; 2) Self-guided Internet based education for social phobia with automatic email reminders. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for social phobia. All participants will complete 8 lessons of Internet based education about management of symptoms of anxiety and social phobia. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with social phobia, taking a further 20 minutes per summary. Participants in Group 1 will receive weekly reminder emails and will have access to written exercises to promote their motivation to continue with the program. Participants in group 2 will receive weekly reminder emails. The duration of the program is 10 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-education, post-education, and at 3-months post-education. These will take about 20 minutes to complete. The educational materials are based on the Shyness Program, which applies cognitive behavioural techniques.

Intervention code [1]

Other interventions

Comparator / control treatment

Internet based education for social phobia with automatic reminder emails.

Control group

Active

Outcomes

Primary outcome [1]

Social phobia is measured by the Social Phobia Scale

Timepoint [1]

Administered at pre-education, post-education, and at 3-months post-education.

Primary outcome [2]

Social phobia is measured by the Social Interaction Anxiety Scale

Timepoint [2]

Administered at pre-education, post-education, and at 3-months post-education.

Secondary outcome [1]

Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)

Timepoint [1]

Administered at application, pre-education, post-education, and at 3-months post-education.

Secondary outcome [2]

Psychological distress is measured by the Kessler-10 (K-10)

Timepoint [2]

Administered at pre-education, post-education, and at 3-months post-education.

Secondary outcome [3]

Disability is measured by the Sheehan Disability Scale

Timepoint [3]

Administered at application, pre-education, post-education, and at 3-months post-education.

Eligibility

Key inclusion criteria

Meet DSM-IV criteria for social phobia - Internet access + printer access. - Australian citizen- Males and females.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Current substance abuse/dependence- Psychotic disorder- Current or planned psychological treatment during study duration- Change in medications during last 1 month or intended change during study duration.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants apply on line, followed by a telephone interview to confirm diagnosis via structured diagnostic interview (MINI 5.0.0). Participants will be randomized using a list generated prior to the study. Allocation concealment will occur by contacting the holder of the allocation schedule who is off-site.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A randomisation list will be generated prior to the study using computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/09/2009

Actual

15/09/2009

Date of last participant enrolment

Anticipated

15/11/2009

Actual

15/11/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

110

Accrual to date

Final

110

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Psychiatry, University of New South Wales at St Vincent's Hospital

Address [1]

299 Forbes Street Darlinghurst NSW2010

Country [1]

Australia

Primary sponsor type

University

Name

School of Psychiatry, University of New South Wales at St Vincent's Hospital

Address

299 Forbes Street Darlinghurst NSW2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales (UNSW) Human Research Ethics Committee (HREC)

Ethics committee address [1]

UNSW Kensington Campus NSW2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/05/2009

Approval date [1]

30/06/2009

Ethics approval number [1]

HREC09151

Summary

Brief summary

This project is part of a research program examining the efficacy of Internet based education and treatment programs for people with social phobia and other commmon mental disorders. This project compares the effectiveness of simple written motivational strategies at encouraging people with social phobia to complete the 8 lessons in the Program. We expect that people who receive the motivational exercises (in addition to weekly reminder emails) will complete more lessons and report greater benefit from the program than participants who do not receive access to the motivational strategies, but do receive email reminders.

Trial website

www.virtualclinic.org.au

Trial related presentations / publications

Titov N, Andrews G, Johnston J, Schwencke G, Choi I. The Shyness program: Longer term benefits, cost-effectiveness, and acceptability. Aust N Z J Psychiatry 2009;43:36-44. 
Titov N, Andrews G, Choi I, Schwencke G, Mahoney J. Shyness 3: An RCT of guided versus unguided Internet based CBT for social phobia. Aust N Z J Psychiatry 2008;42:1030-1040. 
Titov N, Andrews G, Schwencke G. Shyness 2: A replication of Shyness 1. Are the results reliable, and who benefits? Aust N Z J Psychiatry 2008;42:595-605. 
Titov N, Andrews G, Schwencke G, Drobny J, Einstein D. Shyness 1: Distance treatment for social over the Internet. A randomized controlled trial. Aust N Z J Psychiatry 2008;42:585-594. 
Titov N, Andrews G, Choi I, Schwencke G, Johnston J. Internet-based cognitive behavior therapy for social phobia without clinical input is effective: a pragmatic RCT of two types of reminders. Aust N Z J Psychiatry 2009;43:913-919.

Titov N, Gibson M, Andrews G, McEvoy P. Internet treatment for social phobia reduces comorbidity. Aust N Z J Psychiatry 2009;43:754-759.

Public notes

Contacts

Principal investigator

Name

Prof Nick Titov

Address

Department of Psychology
Macquarie University
NSW 2109

Country

Australia

Phone

61 2 9850 9901

Fax

nick.titov@mq.edu.au

Contact person for public queries

Name

Dr Nickolai Titov

Address

C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 83821732

Fax

+61 2 83821721

nickt@unsw.edu.au

Contact person for scientific queries

Name

Dr Nickolai Titov

Address

C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 83821732

Fax

+61 2 83821721

nickt@unsw.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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