Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000235404
Ethics application status
Approved
Date submitted
2/05/2007
Date registered
3/05/2007
Date last updated
3/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet based education for social phobia: An initial randomized controlled study
Scientific title
A randomized controlled study on the effect of Internet based education for treating social phobia using cognitive behavioural techniques.
Secondary ID [1] 288067 0
I do not have a secondary ID - this is an old trial we are trying to close.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia (an anxiety disorder) 1772 0
Condition category
Condition code
Mental Health 1858 1858 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized trial of 6 lessons of Internet based education for people who meet the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for social phobia. One lesson will be completed every 7 to 10 days (each lesson will involve homework, an online discussion forum assignment, email contact with clinicians, and an online reading assignment, requiring up to 4 hours/week) vs wait-list control. Study questionnaires will be administered at application, beginning of the first lesson, 1-week poststudy, and 6 months follow-up. The educational materials are based on the Clinical Management and Treatment Education (CLIMATE) Social Phobia Course, which applies cognitive behavioural techniques. Once Education Group participants have completed the 6 lessons the Wait-List group participants will begin the lessons.
Intervention code [1] 1734 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 2631 0
Social Phobia Scale
Timepoint [1] 2631 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Primary outcome [2] 2632 0
Patient Health Questionnaire-9 (PHQ-9)
Timepoint [2] 2632 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Primary outcome [3] 2633 0
Social Interaction Anxiety Scale
Timepoint [3] 2633 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Primary outcome [4] 2634 0
Kessler-10 (K-10)
Timepoint [4] 2634 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Primary outcome [5] 2635 0
World Health Organisation Disability Assessment Schedule II (WHO-DAS-II)
Timepoint [5] 2635 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Primary outcome [6] 2636 0
Generalised Anxiety Disorder 7-Item Scale (GAD-7)
Timepoint [6] 2636 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Primary outcome [7] 2637 0
Education Questionnaire (assessing knowledge about social phobia - symptoms, and treatment)
Timepoint [7] 2637 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Secondary outcome [1] 4479 0
Change between scores
Timepoint [1] 4479 0
Measured at the time of application and at the beginning of the first lesson.

Eligibility
Key inclusion criteria
Meet DSM-IV criteria for social phobia - Internet access + printer access. - Australian citizen- Males and females- Active pulse.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of cognitive behavioural therapy (CBT)- Current substance abuse/dependence- Psychotic disorder- Current or planned psychological treatment during study duration- Change in medications during last 3 months 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 (CIDI-2). 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
The people analysing the results/data are blinded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/05/2007
Actual
24/05/2007
Date of last participant enrolment
Anticipated
24/07/2007
Actual
24/07/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
193
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 597 0
2010

Funding & Sponsors
Funding source category [1] 2007 0
University
Name [1] 2007 0
Faculty Research Grant, Faculty of Medicine, University of New South Wales
Country [1] 2007 0
Australia
Primary sponsor type
University
Name
School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia
Address
299 Forbes Street
Darlinghurst, NSW2010
Country
Australia
Secondary sponsor category [1] 1818 0
None
Name [1] 1818 0
Nil
Address [1] 1818 0
Country [1] 1818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3729 0
University of New South Wales Ethics Committee,
Ethics committee address [1] 3729 0
Sydney
Ethics committee country [1] 3729 0
Australia
Date submitted for ethics approval [1] 3729 0
Approval date [1] 3729 0
28/03/2007
Ethics approval number [1] 3729 0
07062
Ethics committee name [2] 3730 0
St Vincent's Hospital
Ethics committee address [2] 3730 0
Sydney, NSW
Ethics committee country [2] 3730 0
Australia
Date submitted for ethics approval [2] 3730 0
Approval date [2] 3730 0
16/04/2007
Ethics approval number [2] 3730 0
H07/051

Summary
Brief summary
We will examine the efficacy of an Internet based education program for improving the mental health of people with social phobia. Participants will be recruited via a website developed for this Program (www.shyness.tv), and a structured diagnostic interview via telephone. Consenting participants will be randomly allocated to an active Education Group, or Wait-List Control Group. Participants will complete six lessons of CBT based education delivered via the Internet and weekly emails from a clinician, weekly homework, and weekly contact with other participants via an online discussion board. Participants will be assessed at application, prestudy, one week poststudy, and 6 months poststudy. Once the Education Group have completed the lessons the Control Group will be given access to the lessons.
Trial website
www.shyness.tv
Trial related presentations / publications
Titov, N, Andrews G, Schwencke G, Drobny, J, & Einstein D. (2008). “Shyness 1“: Distance treatment for social over the Internet. A randomized controlled trial. Australian and New Zealand Journal of Psychiatry, 42, 585-594.

Titov, N, Andrews G, & Schwencke G. (2008). “Shyness 2“: Treating social phobia online: replication and extension. Australian and New Zealand Journal of Psychiatry, 42, 595-605.
Public notes

Contacts
Principal investigator
Name 27837 0
Prof Nick Titov
Address 27837 0
Department of Psychology
Macquarie University
NSW 2109
Country 27837 0
Australia
Phone 27837 0
61 2 9850 9901
Fax 27837 0
Email 27837 0
nick.titov@mq.edu.au
Contact person for public queries
Name 10923 0
Prof Dr Nickolai Titov
Address 10923 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD)
299 Forbes Street
Darlinghurst NSW 2010
Country 10923 0
Australia
Phone 10923 0
+61 2 83821732
Fax 10923 0
Email 10923 0
nickt@unsw.edu.au
Contact person for scientific queries
Name 1851 0
Prof Dr Nickolai Titov
Address 1851 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD)
299 Forbes Street
Darlinghurst NSW 2010
Country 1851 0
Australia
Phone 1851 0
+61 2 83821732
Fax 1851 0
Email 1851 0
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

Documents added manually
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Documents added automatically
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