Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000888662
Ethics application status
Approved
Date submitted
11/08/2014
Date registered
21/08/2014
Date last updated
15/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive Cognitive Behavioural Therapy for Social Anxiety Disorder: A Pilot Study
Scientific title
Effect of intensive cognitive behavioural therapy on severity of symptoms in people with social anxiety disorder: A pilot study
Secondary ID [1] 285104 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 292708 0
Condition category
Condition code
Mental Health 293015 293015 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete three therapy sessions per week over four weeks (a total of 12 sessions). Therapy sessions will be delivered one-on-one by a provisional psychologist and the duration of sessions will be 60 minutes. The content of sessions will follow common cognitive-behavioural treatments for social anxiety disorder, including psycho-education, cognitive restructuring and behavioural experiments. A treatment manual will be developed for use in this study. The methods used will aim to reduce social anxiety symptoms such as maladaptive thoughts about social situations (cognitive restructuring), and beliefs about catastrophic consequences of behaviour in social contexts (behavioural experiments). The aim of this study is for participants to experience a reduction in symptoms sooner, and potentially increase efficacy of CBT for social anxiety disorder by reducing the timeframe in which treatment is delivered.
Intervention code [1] 289988 0
Behaviour
Intervention code [2] 290043 0
Treatment: Other
Comparator / control treatment
This is an open trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292875 0
Social Phobia Inventory
Timepoint [1] 292875 0
Baseline
Post-treatment
3-month follow up
Primary outcome [2] 292876 0
Social Phobia Scale
Timepoint [2] 292876 0
Baseline
Post-treatment
3-month follow up
Primary outcome [3] 292877 0
Social Interaction Anxiety Scale
Timepoint [3] 292877 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [1] 309864 0
Depression Anxiety Stress Scale
Timepoint [1] 309864 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [2] 309865 0
Sheehan Disability Scale
Timepoint [2] 309865 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [3] 309866 0
Mini- Social Phobia Inventory
Timepoint [3] 309866 0
Each treatment session

Eligibility
Key inclusion criteria
Aged over 14.
Able to attend treatment sessions three times per week for four weeks at the University of Tasmania Psychology Clinic.
Primary diagnosis of social anxiety disorder.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current suicidal intent or plans.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via referrals to the University of Tasmania Psychology Clinic, flyers in the Hobart area, and mail-outs to health services. Participants will first complete an online screening questionnaire and a telephone screening; if inclusion and exclusion criteria are met, then the participant will meet a researcher for an interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a non-randomised control trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2014
Actual
25/08/2014
Date of last participant enrolment
Anticipated
5/12/2014
Actual
5/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 289745 0
University
Name [1] 289745 0
University of Tasmania
Country [1] 289745 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Department of Psychology
School of Medicine
Faculty of Health
University of Tasmania
Private Bag 30
Hobart
TAS 7001
Country
Australia
Secondary sponsor category [1] 288438 0
None
Name [1] 288438 0
Address [1] 288438 0
Country [1] 288438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291476 0
Tasmania Social Sciences Human Research Ethics Committee
Ethics committee address [1] 291476 0
Health and Medical Human Research Ethics Committee
Research Integrity and Ethics Unit
Office of Research Services
University of Tasmania
Private Bag 01
Hobart Tas 7001
Ethics committee country [1] 291476 0
Australia
Date submitted for ethics approval [1] 291476 0
Approval date [1] 291476 0
29/07/2014
Ethics approval number [1] 291476 0
H0014034

Summary
Brief summary
This study is intended to investigate the efficacy of intensive cognitive behavioural therapy for social anxiety disorder. The effect of this intervention will be analysed, and participants will be questioned about the acceptability of the intensive treatment format. The results of this study will hopefully inform us of any benefit of intensive individual CBT for the treatment of social anxiety disorder.
Trial website
Trial related presentations / publications
There are currently no publication relevant to this study.
Public notes

Contacts
Principal investigator
Name 50446 0
Dr Bethany Wootton
Address 50446 0
Division of Psychology
School of Medicine
Faculty of Health
University of Tasmania
Private Bag 30, Hobart TAS 7001
Country 50446 0
Australia
Phone 50446 0
+61 3 6226 7124
Fax 50446 0
Email 50446 0
Bethany.Wootton@utas.edu.au
Contact person for public queries
Name 50447 0
Miss Alexandra Hunn
Address 50447 0
Division of Psychology
School of Medicine
Faculty of Health
University of Tasmania
Private Bag 30
Hobart TAS 7001
Country 50447 0
Australia
Phone 50447 0
61407319488
Fax 50447 0
Email 50447 0
hunna@utas.edu.au
Contact person for scientific queries
Name 50448 0
Miss Alexandra Hunn
Address 50448 0
Division of Psychology
School of Medicine
Faculty of Health
University of Tasmania
Private Bag 30
Hobart TAS 7001
Country 50448 0
Australia
Phone 50448 0
61407319488
Fax 50448 0
Email 50448 0
hunna@utas.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.