Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000317493
Ethics application status
Approved
Date submitted
18/05/2007
Date registered
14/06/2007
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Attention re-training for social phobia
Scientific title
Does attention re-training provide an additive or multiplicative effect when used in conjunction with group cognitive behavioural therapy in reducing the symptoms and severity of social phobia in outpatients with a primary diagnosis of social phobia?
Secondary ID [1] 296665 0
Nil known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Phobia 1863 0
Condition category
Condition code
Mental Health 1959 1959 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be completing our highly efficacious, best-practice Cognitive Behavioural Group program for Social Phobia. The program consists of 12 weekly sessions, each of approximately 2.5 hours duration, conducted over consecutive weeks. This enhanced group program has been developed through an National Health and Medical Research Council (NHMRC) funded Randomised Controlled Trial (RCT) at our clinic and has been shown to have treatment effects superior to standard treatment packages for social phobia. Treatment will be led by a clinical psychologist or graduate student in clinical psychology in groups of between six to eight participants.
In addition to all participants receiving the best available treatment through our clinic, each group of participants will also be block allocated to receive either active attention re-training, or a placebo attention task as an adjunct to treatment. In both conditions participants will be required to complete an attention task approximately ten minutes in length which is delivered via a computer program. This task will be conducted at the beginning of each group session at the clinic, and is then completed as homework by the participants on their personal computer for the subsequent six days prior to the next session. Participants will each be provided with a USB flash drive from which they can both run the program and save their data (coded by a de-identified number) for retrieval by the research assistant. Arrangements will be made to loan computers to those participants who do not have a computer at home.
The attention re-training task involves simultaneous presentation of a socially threatening word (e.g. foolish) with a neutral word (e.g. portion) followed by a probe in the position of one of these words. Participants are instructed to indicate the position of the probe as quickly as possible using the left and right arrow key on their keyboard. In the condition designed to train attention away from threat the probe will always replace the neutral verbal cue. In the placebo condition the probe will appear in the position vacated by the threatening or neutral cue with equal probability. Thus participants in the placebo condition will experience all the same training contexts as those in the re-training condition, but will not be trained to focus away from threat.
Four weeks after the final session of the 12 week group program all participants will be complete the Anxiety Disorders Interview Schedule 4th Edition (ADIS IV) and the same battery of measures that was collected at the initial assessment. This same procedure will also be completed six months after the date of group completion. Any participants who require further follow-up at the completion of the program will be provided with suitable referral options for ongoing care.
Intervention code [1] 1767 0
Treatment: Other
Comparator / control treatment
Control intervention involves attention training to random stimuli
Control group
Active

Outcomes
Primary outcome [1] 2774 0
The primary outcome is reduction in symptoms and severity of social phobia.
Measures -
Diagnosis: All participants will attend a clinical interview aimed at providing a formal diagnosis which will be made on the basis of the Anxiety Disorders Interview Schedule (ADIS-IV: (Di Nardo, Brown, & Barlow, 1994) according to DSM-IV criteria. All diagnostic interviews will be audio-taped and a random 25% will be listened to and scored by an experienced interviewer to determine diagnostic reliability for this study.
Questionnaire Measures: To assess symptoms and severity of social phobia four measures will be used: The Social Phobia Scale (SPS; Mattick and Clarke 1998) assesses fear and avoidance of situations where there is the prospect of being observed by others (performance fears). The Social Interaction Anxiety Scale (SIAS; Mattick and Clarke 1998) assesses distress when meeting or talking to other people (interaction fears). The Liebowitz Social Anxiety Scale - Self-Report version (LSAS-SR; Baker, Heinrichs et al. 2002) assesses fear and avoidance for 11 interaction and 13 performance situations. The Personal Report of Confidence as a Speaker (PRCS; Paul 1966) measures fear of public speaking. The SPS, SIAS, LSAS-SR, and PRCS have all been demonstrated to have sound psychometric properties.
Timepoint [1] 2774 0
Four weeks after the final session of the 12 week group program all participants will be complete the ADIS IV and the same battery of measures that was collected at the initial assessment. This same procedure will also be completed six months after the date of group completion.
Secondary outcome [1] 4674 0
Secondary outcomes are a reduction in the level of interference caused by social phobia to overall functioning, including daily activities and health utilisation.
Measures:
In order to examine socially relevant treatment effects, two measures will be included to assess broader aspects of overall functioning in addition to basic symptomatology and diagnosis. The SF12 (Ware, Kosinski et al. 1996) assesses the overall degree to which an individual’s symptoms influence his or her life and cause an impact on their daily activities and health utilisation, and the Life Interference Scale is a series of Likert scales which measure the degree to which symptoms limit various aspects of an individual’s life. Finally, participants will complete the Anxiety Change Expectancy Scale (ACES; Dezois and Westra 2005) which is a reliable and valid measure of expectancies for changing anxiety.
Timepoint [1] 4674 0
Four weeks after the final session of the 12 week group program all participants will be complete the same battery of measures that was collected at the initial assessment. This same procedure will also be completed six months after the date of group completion.

Eligibility
Key inclusion criteria
Participants must meet Diagnostic & Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for social phobia. If multiple anxiety disorders are present, social phobia must be the principal diagnosis based on severity and life interference. Participants will be required to be fluent in their use of English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current, active suicidal ideation, organic mental disorders, a co-morbid psychotic disorder, or current, unmanaged substance dependence.

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)
Allocation to a treatment condition is managed by the Research Coordinator from a central administration site. The Research Coordinator is contacted when it is determined that a participant is eligible for treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Both the participants in the trial, and the therapists delivering the treatment are blind to the allocation of treatment condition.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
1/07/2010
Date of last data collection
Anticipated
Actual
31/12/2010
Sample size
Target
250
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 24767 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 2098 0
Government body
Name [1] 2098 0
National Health and Medical Research Council (NHMRC)
Country [1] 2098 0
Australia
Primary sponsor type
Individual
Name
Professor Ronald M Rapee
Address
Department of Psychology
Macquarie University
Sydney NSW Australia 2109
Country
Australia
Secondary sponsor category [1] 1904 0
None
Name [1] 1904 0
N/A
Address [1] 1904 0
Country [1] 1904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3890 0
Macquarie University, Centre for Emotional Health
Ethics committee address [1] 3890 0
Ethics committee country [1] 3890 0
Australia
Date submitted for ethics approval [1] 3890 0
Approval date [1] 3890 0
02/05/2007
Ethics approval number [1] 3890 0
RO5197

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

Contacts
Principal investigator
Name 27870 0
Prof Ronald Rapee
Address 27870 0
Department of Psychology Macquarie University Balaclava Rd North Ryde NSW 2109
Country 27870 0
Australia
Phone 27870 0
+61 2 9850 8032
Fax 27870 0
Email 27870 0
[email protected]
Contact person for public queries
Name 10956 0
Ronald Rapee
Address 10956 0
Department of Psychology
Macquarie University
Balaclava Rd
North Ryde NSW 2109
Country 10956 0
Australia
Phone 10956 0
+61 2 98508032
Fax 10956 0
+61 2 98508062
Email 10956 0
[email protected]
Contact person for scientific queries
Name 1884 0
Professor Ron Rapee, Chief Investigator
Address 1884 0
Department of Psychology
Macquarie University
Balaclava Rd
North Ryde NSW 2109
Country 1884 0
Australia
Phone 1884 0
+61 2 98508032
Fax 1884 0
+61 2 98508062
Email 1884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not in ethical approval


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.