Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000192381
Ethics application status
Approved
Date submitted
9/04/2008
Date registered
11/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-Based Treatment for Social Phobia: Is a Therapist Necessary?
Scientific title
A randomized controlled study on the role of therapist in an Internet-based treatment program for social phobia using cognitive behavioural techniques
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia 3026 0
Condition category
Condition code
Mental Health 3179 3179 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized trial of the Shyness Program, a six lesson Internet-based treatment program for people with social phobia, that includes therapist support, vs the Shyness Program, but without therapist support. All participants will meet the Diagnostic and Statistical Manual - 4th Edition (DSM-IV) criteria for social phobia. The Shyness Treatment program is an effective Internet-based treatment program for social phobia (Titov et al, 2008a, 2008b). This program involves four components: 6 on-line lessons ; homework assignments; participation in an on-line discussion forum, and regular email contact with a therapist. Once the two treatment groups have completed the Shyness Program (8 - 10 weeks) the Waitlist Control group will begin the program.
Intervention code [1] 2770 0
Treatment: Other
Comparator / control treatment
Treatment using the Shyness Program vs the Shyness Program but without therapist support. The Control Group will complete the study measures at the same time points as the treatment groups (about 10 weeks apart). Once the treatment groups have completed the program the control group will begin the full Shyness program.
Control group
Active

Outcomes
Primary outcome [1] 4065 0
Social Interaction Anxiety Scale
Timepoint [1] 4065 0
Administered at pre-treatment, post-treatment (one week), and at 6 month follow-up.
Primary outcome [2] 4066 0
Social Phobia Scale
Timepoint [2] 4066 0
Administered at pre-treatment, post-treatment (one week), and at 6 month follow-up.
Primary outcome [3] 4067 0
Patient Health Questionnaire - 9 Item
Timepoint [3] 4067 0
Administered at pre-treatment, post-treatment (one week), and at 6 month follow-up.
Secondary outcome [1] 6836 0
Kessler 10
Timepoint [1] 6836 0
Administered at pre-treatment, post-treatment (one week), and at 6 month follow-up.
Secondary outcome [2] 6837 0
Generalised Anxiety Disorder 7-Item Scale (GAD-7)
Timepoint [2] 6837 0
Administered at pre-treatment, post-treatment (one week), and at 6 month follow-up.
Secondary outcome [3] 6838 0
World Health Organization Disability Assessment Schedule-Second Edition (WHODAS-II)
Timepoint [3] 6838 0
Administered at pre-treatment, post-treatment (one week), and at 6 month follow-up.
Secondary outcome [4] 6839 0
Estimates of weekly avoidance and activity levels
Timepoint [4] 6839 0
Administered at pre-treatment, post-treatment (one week), and at 6 month follow-up.

Eligibility
Key inclusion criteria
Meet DSM-IV criteria for social phobia
Internet access + printer
Australian citizen
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe depression/suicidality
Current substance use/dependence
Psychosis
Change in medication for social phobia in last month or intended change
Current CBT treatment for social phobia or anticipated

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 on-line, followed by a telephone interview to confirm diagnosis via a structured diagnostic interview (MINI). Participants will be randomized using a list generated prior to the study. Allocation concealment will occur by contacting the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization list will be generated prior to the study using computer software (www.random.org).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
20/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3282 0
University
Name [1] 3282 0
Clinical Research Unit for Anxiety and Depression
Country [1] 3282 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital: Clinical Research Unit for Anxiety and Depression
Address
CRUfAD
St Vincent's Hospital
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 2937 0
None
Name [1] 2937 0
Address [1] 2937 0
Country [1] 2937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5270 0
St Vincent's Hospital HREC
Ethics committee address [1] 5270 0
Ethics committee country [1] 5270 0
Australia
Date submitted for ethics approval [1] 5270 0
Approval date [1] 5270 0
07/04/2008
Ethics approval number [1] 5270 0
HREC08/SVH/36

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28513 0
Address 28513 0
Country 28513 0
Phone 28513 0
Fax 28513 0
Email 28513 0
Contact person for public queries
Name 11670 0
Dr Nickolai Titov
Address 11670 0
Clinical Research Unit for Anxiety and Depression
299 Forbes Street
Darlinghurst
NSW 2010
Country 11670 0
Australia
Phone 11670 0
612 8382 1732
Fax 11670 0
612 8382 1721
Email 11670 0
[email protected]
Contact person for scientific queries
Name 2598 0
Dr Nickolai Titov
Address 2598 0
Clinical Research Unit for Anxiety and Depression
299 Forbes Street
Darlinghurst
NSW 2010
Country 2598 0
Australia
Phone 2598 0
612 8382 1732
Fax 2598 0
612 8382 1721
Email 2598 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.