Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001314617
Ethics application status
Not yet submitted
Date submitted
16/11/2014
Date registered
16/12/2014
Date last updated
16/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An online educational program to assist shy people to understand social anxiety and seek help.
Scientific title
A pilot randomised controlled trial to evaluate the effect of an online shyness information program on the help seeking intentions of adults with social anxiety.
Secondary ID [1] 285682 0
Nil
Universal Trial Number (UTN)
U1111-1164-12085
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social anxiety 293538 0
Condition category
Condition code
Mental Health 293811 293811 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single module information website comprising information about social anxiety and feedback about the participant's level of social anxiety. The module will take approximately 20-30 minutes to complete and will be completed in one session.
Intervention code [1] 290624 0
Behaviour
Comparator / control treatment
A wellbeing/health information website focusing on physical activity information. No information on anxiety is included. The module is of a similar length to the Intervention module and will take approximately 20-30 minutes to complete. It will be completed in one session.
Control group
Placebo

Outcomes
Primary outcome [1] 293601 0
Help seeking intention as measured by General Help-seeking Questionnaire (GHSQ).
Timepoint [1] 293601 0
Immediately post-intervention
Secondary outcome [1] 311447 0
Help seeking attitudes as measured by the Attitudes to Seeking Professional Psychological Help Scale-Short Form (ATSPPH-SF): 3 items only (adapted)
Timepoint [1] 311447 0
Immediately Post-intervention
Secondary outcome [2] 311448 0
Perceived need for treatment for social anxiety (single item).
5 point likert scale.
Timepoint [2] 311448 0
Immediately Post-intervention
Secondary outcome [3] 311449 0
Help seeking intention as measured by response to an invitation to access an online evidence based self help intervention.
Timepoint [3] 311449 0
Immediately Post-intervention
Secondary outcome [4] 311450 0
Social anxiety knowledge as measured by the S-Lit
Timepoint [4] 311450 0
Immediately Post-Intervention
Secondary outcome [5] 311451 0
Internalised social anxiety stigma as measured by the SASS
Timepoint [5] 311451 0
Immediately Post-intervention

Eligibility
Key inclusion criteria
Participants who self report shyness. Main data analysis to be undertaken on those scoring above cutoff for caseness on the Social Phobia Anxiety Inventory (SPIN >=19). A second data analysis will be undertaken on those scoring above the cutoff score for Batterham's Social Phobia Scale (SOPHS).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those not self-reporting shyness.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 6480 0
United States of America
State/province [1] 6480 0
No restriction
Country [2] 6481 0
Canada
State/province [2] 6481 0
No restriction
Country [3] 6482 0
New Zealand
State/province [3] 6482 0
No restriction

Funding & Sponsors
Funding source category [1] 290253 0
University
Name [1] 290253 0
ANU
Country [1] 290253 0
Australia
Primary sponsor type
Individual
Name
Kathleen Griffiths
Address
National Institute for Mental Health Research,
Research School of Population Health,
The Australian National University
63 Eggleston Crescent,
Acton,
Canberra,
ACT. 2601
Country
Australia
Secondary sponsor category [1] 288960 0
None
Name [1] 288960 0
Address [1] 288960 0
Country [1] 288960 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291952 0
ANU Human Research Ethics Committee
Ethics committee address [1] 291952 0
National Institute for Mental Health Research,
Research School of Population Health,
Australian National University
63 Eggleston Crescent,
Acton,
Canberra,
ACT. 2601
Ethics committee country [1] 291952 0
Australia
Date submitted for ethics approval [1] 291952 0
14/11/2014
Approval date [1] 291952 0
Ethics approval number [1] 291952 0
2014/739

Summary
Brief summary
A pilot randomised controlled trial to evaluate the effect of an online shyness information program on the help seeking intentions of adults with social anxiety. The primary aim of the study is to collect data that will demonstrate the feasibility of the recruitment procedures and inform the design of an appropriately powered trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52834 0
Prof Kathleen Griffiths
Address 52834 0
National Institute for Mental Health Research,
Research School of Population Health,
The Australian National University
63 Eggleston Crescent,
Acton,
Canberra,
ACT. 2601
Country 52834 0
Australia
Phone 52834 0
+61 02 6125 5111
Fax 52834 0
Email 52834 0
[email protected]
Contact person for public queries
Name 52835 0
Prof Kathleen Griffiths
Address 52835 0
National Institute for Mental Health Research,
Research School of Population Health,
The Australian National University
63 Eggleston Crescent,
Acton,
Canberra,
ACT. 2601
Country 52835 0
Australia
Phone 52835 0
+61 2 6125 5111
Fax 52835 0
Email 52835 0
[email protected]
Contact person for scientific queries
Name 52836 0
Prof Kathleen Griffiths
Address 52836 0
National Institute for Mental Health Research,
Research School of Population Health,
The Australian National University
63 Eggleston Crescent,
Acton,
Canberra,
ACT. 2601
Country 52836 0
Australia
Phone 52836 0
+61 2 6125 5111
Fax 52836 0
Email 52836 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.