Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000212257
Ethics application status
Approved
Date submitted
6/03/2009
Date registered
27/04/2009
Date last updated
7/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet vs. face to face cognitive behavioural therapy for social phobia
Scientific title
A randomised controlled trial comparing Internet versus face-to-face cognitive behavioural therapy treatment on severity of symptoms of social phobia
Secondary ID [1] 288086 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia (an anxiety disorder) 4430 0
Condition category
Condition code
Mental Health 4697 4697 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) Internet based treatment for social phobia or; 2) Face-to-face based treatment for social phobia.
All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for social phobia. All participants will complete evidence-based materials about cognitive behavioural techniques for managing symptoms of social phobia. The Internet group will complete 6 online lessons over 8 weeks. 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 receiving face-to-face treatment will complete 7 lessons of face to face manualised and evidence-based treatment for symptoms of social phobia, over a 7 week period, with one lesson per week. Each lesson will take 3 hours, and participants will be treated in a group format with 6 - 8 participants. Each group will be led by a psychologist or psychiatrist.

Participants will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at immediately pre-treatment, one-week post-treatment, and at 3-months post-treatment. These will take about 20 minutes to complete.
Intervention code [1] 4174 0
Treatment: Other
Comparator / control treatment
Face-to-face treatment program for social phobia.
Control group
Active

Outcomes
Primary outcome [1] 5563 0
Social phobia is measured by the Social Phobia Scale
Timepoint [1] 5563 0
Administered immediately pre-treatment, one -week post-treatment, and at 3-months post-treatment.
Primary outcome [2] 5564 0
Social phobia is measured by the Social Interaction Anxiety Scale
Timepoint [2] 5564 0
Administered immediately pre-treatment, one -week post-treatment, and at 3-months post-treatment.
Secondary outcome [1] 9374 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 9374 0
Administered immediately pre-treatment, one -week post-treatment, and at 3-months post-treatment.
Secondary outcome [2] 9375 0
Psychological distress is measured by the Kessler-10 (K-10)
Timepoint [2] 9375 0
Administered immediately pre-treatment, one -week post-treatment, and at 3-months post-treatment.
Secondary outcome [3] 9376 0
Disability is measured by the Sheehan Disability Scale
Timepoint [3] 9376 0
Administered immediately pre-treatment, one -week post-treatment, and at 3-months post-treatment.

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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply at the Anxiety Disorders Clinic, St Vincent's Hospital, Sydney, to receive treatment for social phobia. All applicants receive a psychiatric interview to determine diagnosis and eligibility.

Participants who meet inclusion criteria and wish to participate 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
16/04/2009
Actual
16/04/2009
Date of last participant enrolment
Anticipated
Actual
16/05/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4619 0
Government body
Name [1] 4619 0
NSW Institute of Psychiatry
Country [1] 4619 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria Street
Darlinghurst
NSW2010
Country
Australia
Secondary sponsor category [1] 4165 0
None
Name [1] 4165 0
Address [1] 4165 0
Country [1] 4165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6662 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 6662 0
390 Victoria Street
Darlinghurst
NSW2010
Ethics committee country [1] 6662 0
Australia
Date submitted for ethics approval [1] 6662 0
Approval date [1] 6662 0
04/03/2009
Ethics approval number [1] 6662 0
HREC/09/SVH/11

Summary
Brief summary
The efficacy of treatment for social phobia at the Anxiety Disorders Clinic is proven with benefits in the short and long term exceeding 1 standard deviation (SD) (McEvoy, 2007). Therapy over the internet has also been shown to be efficacious, again with benefits in the short and long term exceeding 1 SD (Titov et al, 2009). Whilst on this basis the two modes of therapy appear comparable in efficacy we cannot know whether people applying for internet therapy are particularly suited to that mode of treatment and whether people applying for face to face therapy are suited to that mode of therapy. Internet therapy has service delivery advantages in terms of substantial reductions in therapist time and reductions in patient costs in terms of transport to the clinic which averages $30 per visit, and in terms of loss of wages or cost of carers while away from home.
Trial website
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. Submitted.
Public notes

Contacts
Principal investigator
Name 29359 0
Prof Nickolai Titov
Address 29359 0
eCentreClinic, Department of Psychology, Macquarie University, Balaclava Road, North Ryde
NSW, 2109, Australia
Country 29359 0
Australia
Phone 29359 0
+61 2 98509901
Fax 29359 0
Email 29359 0
[email protected]
Contact person for public queries
Name 12606 0
Professor Gavin Andrews
Address 12606 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) University of New South Wales (UNSW) 299 Forbes Street Darlinghurst NSW 2010
Country 12606 0
Australia
Phone 12606 0
+61 2 8382 1726
Fax 12606 0
+61 2 8382 1721
Email 12606 0
[email protected]
Contact person for scientific queries
Name 3534 0
Professor Gavin Andrews
Address 3534 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 3534 0
Australia
Phone 3534 0
+61 2 8382 1726
Fax 3534 0
+61 2 8382 1721
Email 3534 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



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