Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01093313




Registration number
NCT01093313
Ethics application status
Date submitted
24/03/2010
Date registered
25/03/2010
Date last updated
25/03/2010

Titles & IDs
Public title
Attention Training and Cognitive Therapy
Scientific title
Comparison of Attention Training and Cognitive Therapy in the Treatment of Social Phobia: a Randomized Controlled Trial
Secondary ID [1] 0 0
USydney9274
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Attention training -

Active comparator: Cognitive therapy -

Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* 18 years of age,
* be fluent in English
* have a primary concern of social anxiety that met DSM-IV criteria (APA, 2000) for social phobia. Both subtypes of social phobia, specific and generalized, were accepted into the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* the presence of comorbid condition(s) that were more severe than the presenting social phobia

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The present study aimed to investigate the efficacy and process of change that occurs in Attention Training in comparison to an established treatment for social phobia, Cognitive Therapy. A randomized trial was conducted in which participants were allocated to either six weeks of Attention Training or Cognitive Therapy. It was hypothesized that both treatments would be effective in reducing social phobia symptoms, but that Attention Training would work primarily by reducing levels of self focused attention, while Cognitive Therapy would work through changes to probability and threat appraisals.
Trial website
https://clinicaltrials.gov/study/NCT01093313
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maree Abbott, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01093313