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Trial registered on ANZCTR


Registration number
ACTRN12608000465358
Ethics application status
Approved
Date submitted
3/09/2008
Date registered
17/09/2008
Date last updated
2/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-guided Internet based education for social phobia: A randomized controlled study
Scientific title
A comparison of self-guided Internet based education for social phobia with automatic reminders vs. telephone reminders: A randomized controlled trial.
Secondary ID [1] 288053 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia (an anxiety disorder) 3639 0
Condition category
Condition code
Mental Health 3803 3803 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 automatic email and sms reminders, or; 2) self-guided Internet based education for social phobia with automatic email and sms reminders, and weekly telephone reminders from an administrative assistant.

All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for social phobia.

All participants will complete 6 lessons of Internet based education about management of symptoms of 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 emails and fortnightly sms reminder messages to continue with the program. Participants in group 2 will receive weekly emails and fortnightly sms reminder messages as well as weekly telephone reminders from a research assistant. The duration of each phone call is expected to be 2 minutes. The duration of the program is 8 weeks, but participants will be contacted 6 months post program and asked to complete follow-up questionnaires.

Study questionnaires will be administered at application, pre-education, post-education, and at 6-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] 3351 0
Other interventions
Comparator / control treatment
Self-guided Internet based education for social phobia with automatic email and SMS reminders.
Control group
Active

Outcomes
Primary outcome [1] 4700 0
Social phobia is measured by the Social Phobia Scale
Timepoint [1] 4700 0
Administered at application, pre-education, post-education, and at 6-months post-education.
Primary outcome [2] 4701 0
Social phobia is measured by the Social Interaction Anxiety Scale
Timepoint [2] 4701 0
Administered at application, pre-education, post-education, and at 6-months post-education.
Secondary outcome [1] 7926 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 7926 0
Administered at application, pre-education, post-education, and at 6-months post-education.
Secondary outcome [2] 7927 0
Psychological distress is measured by the Kessler-10 (K-10)
Timepoint [2] 7927 0
Administered at application, pre-education, post-education, and at 6-months post-education.
Secondary outcome [3] 7928 0
Disability is measured by the World Health Organisation Disability Assessment Schedule II
Timepoint [3] 7928 0
Administered at application, pre-education, post-education, and at 6-months post-education.
Secondary outcome [4] 7929 0
Generalised anxiety is measured by the Generalised Anxiety Disorder 7-Item Scale (GAD-7)
Timepoint [4] 7929 0
Administered at application, pre-education, post-education, and at 6-months post-education.

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
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
6/10/2008
Actual
6/10/2008
Date of last participant enrolment
Anticipated
Actual
6/12/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3816 0
University
Name [1] 3816 0
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Country [1] 3816 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] 3425 0
None
Name [1] 3425 0
Address [1] 3425 0
Country [1] 3425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5876 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 5876 0
UNSW
Kensington Campus
NSW2052
Ethics committee country [1] 5876 0
Australia
Date submitted for ethics approval [1] 5876 0
Approval date [1] 5876 0
01/09/2008
Ethics approval number [1] 5876 0
08230

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. This project compares the effectiveness of different types of reminders at encouraging people with social phobia to complete the 6 lessons in the Program. We expect that people who receive telephone reminders (in addition to weekly emails and fortnightly smss) will complete more lessons and report more benefit from the program than participants who do not receive the weekly phone call (but who do receive the email and sms reminders).
Trial website
www.climateclinic.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: A replication of Shyness 1. Are the results reliable, and who benefits? Australian and New Zealand Journal of Psychiatry, 42, 595-605.

Titov, N, Andrews, G, Choi, I, Schwencke, G. (In press). Shyness 3: An RCT of guided versus unguided Internet based CBT for social phobia. Australian and New Zealand Journal of Psychiatry.
Public notes

Contacts
Principal investigator
Name 28897 0
A/Prof Nickolai Titov
Address 28897 0
eCentreClinic
Centre for Emotional Health, Department of Psychology
Macquarie University
Talavera Road, North Ryde, NSW 2109
Country 28897 0
Australia
Phone 28897 0
+61 2 9850 9901
Fax 28897 0
Email 28897 0
[email protected]
Contact person for public queries
Name 12054 0
Dr Nickolai Titov
Address 12054 0
eCentreClinic
Centre for Emotional Health, Department of Psychology
Macquarie University
Talavera Road, North Ryde, NSW 2109
Country 12054 0
Australia
Phone 12054 0
+61 2 9850 9901
Fax 12054 0
Email 12054 0
[email protected]
Contact person for scientific queries
Name 2982 0
Dr Nickolai Titov
Address 2982 0
eCentreClinic
Centre for Emotional Health, Department of Psychology
Macquarie University
Talavera Road, North Ryde, NSW 2109
Country 2982 0
Australia
Phone 2982 0
+61 2 9850 9901
Fax 2982 0
Email 2982 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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