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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] 1211 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia (an anxiety disorder) 256420 0
Condition category
Condition code
Mental Health 256594 256594 0 0
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] 255716 0
Other interventions
Comparator / control treatment
Internet based education for social phobia with automatic reminder emails.
Control group
Active

Outcomes
Primary outcome [1] 257480 0
Social phobia is measured by the Social Phobia Scale
Timepoint [1] 257480 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [2] 257481 0
Social phobia is measured by the Social Interaction Anxiety Scale
Timepoint [2] 257481 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [1] 262676 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 262676 0
Administered at application, pre-education, post-education, and at 3-months post-education.
Secondary outcome [2] 262677 0
Psychological distress is measured by the Kessler-10 (K-10)
Timepoint [2] 262677 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [3] 262678 0
Disability is measured by the Sheehan Disability Scale
Timepoint [3] 262678 0
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?
No
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] 256188 0
University
Name [1] 256188 0
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Country [1] 256188 0
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] 251531 0
None
Name [1] 251531 0
Address [1] 251531 0
Country [1] 251531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258296 0
University of New South Wales (UNSW) Human Research Ethics Committee (HREC)
Ethics committee address [1] 258296 0
UNSW Kensington Campus NSW2052
Ethics committee country [1] 258296 0
Australia
Date submitted for ethics approval [1] 258296 0
24/05/2009
Approval date [1] 258296 0
30/06/2009
Ethics approval number [1] 258296 0
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 30629 0
Prof Nick Titov
Address 30629 0
Department of Psychology
Macquarie University
NSW 2109
Country 30629 0
Australia
Phone 30629 0
61 2 9850 9901
Fax 30629 0
Email 30629 0
[email protected]
Contact person for public queries
Name 13876 0
Dr Nickolai Titov
Address 13876 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 13876 0
Australia
Phone 13876 0
+61 2 83821732
Fax 13876 0
+61 2 83821721
Email 13876 0
[email protected]
Contact person for scientific queries
Name 4804 0
Dr Nickolai Titov
Address 4804 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 4804 0
Australia
Phone 4804 0
+61 2 83821732
Fax 4804 0
+61 2 83821721
Email 4804 0
[email protected]

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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