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Trial registered on ANZCTR


Registration number
ACTRN12616000598482p
Ethics application status
Submitted, not yet approved
Date submitted
5/05/2016
Date registered
9/05/2016
Date last updated
9/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The relative efficacy of cognitive bias modification for interpretation or attention in social anxiety
Scientific title
The relative efficacy of cognitive bias modification for interpretation or attention in social anxiety
Secondary ID [1] 289137 0
Nil
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social anxiety 298639 0
Condition category
Condition code
Mental Health 298703 298703 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will compare three active treatments: cognitive bias modification for attention (CBM-A), cognitive bias modification for interpretation (CBM-I) and a combined arm (i.e. CBM-AI). All treatments are given on one single occasion and matched for time. The tasks take approximately 20-30 minutes. All are administered on a computer.

Cognitive bias modification of interpretation trains participants to interpret ambiguous sentences in a neutral manner by giving feedback that the sentences are not associated with a word that has salience for social threat. 496 trials are presented.

Cognitive bias modification for attention involves implicitly training participants to attend to a non-threatening word by presenting word pairs (threat/neutral pairs) and consistently replacing the neutral (rather than threatening word) with a probe, Participants must identify the probe via key press as quickly as possible. There will be 640 trials.

CBM-AI: combines both and in order to match the length of the intervention, the number of trials of each of the interventions is halved.
Intervention code [1] 294653 0
Treatment: Other
Comparator / control treatment
A placebo group will be included that uses the same experimental stimuli as CBM-A and CBM-I, except that in CBM-A there is no contingency between the probe and the target; and in CBM-I there is no feedback. Hence participants receive the same stimuli but without any attempt to modify the biases of attention or interpretation.
Control group
Placebo

Outcomes
Primary outcome [1] 298185 0
Average score on Social Anxiety Response Scale to assess social anxiety.
Timepoint [1] 298185 0
Immediately after CBM
Primary outcome [2] 298186 0
Average score on Social Anxiety Response Scale to assess social anxiety.
Timepoint [2] 298186 0
immediately following the post-social stress task. The social stress task asks participants to describe in a group for five minutes why they are a good person
Secondary outcome [1] 323429 0
Attention Bias will be assessed using the dot-probe task (same task as for CBM-A), however, in test trials the probe will occur as often replacing the neutral as the threat word. An attentional bias is inferred when participants respond more quickly to trials where the probe replaces the threat word than the neutral word.
Timepoint [1] 323429 0
The test is part of the CBM protocol and therefore occurs both immediately before and after the CBM training phase.
Secondary outcome [2] 323431 0
interpretation bias: Interpretation bias is assessed using the same task as is used to train interpretation. However, in test trials different stimuli are used and no feedback is given. An interpretation bias is inferred on the basis of how many threat-related interpretations the participant completes.
Timepoint [2] 323431 0
The test is part of the CBM protocol and therefore occurs both immediately before and after the CBM training phase.
Secondary outcome [3] 323433 0
Coding. The videotapes of the social interaction task will be recorded and scored by a researcher who is blind to the group allocation. They will be coded, for amount of time (in minutes) that each person spoke for; and ratings of confidence and nervousness.
Timepoint [3] 323433 0
During the five minute social interaction task (after training)

Eligibility
Key inclusion criteria
We will recruit participants who score one standard deviation above the average on the Social Interaction Anxiety Scale. Participants will be first year Psychology undergraduate students at the University of Sydney.
Minimum age
17 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Low levels of social anxiety

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)
Particpiants will be tested in groups of four. Groups of the numbers 1,2,3,4 will be developed, where the order randomly determined using randomizer.org. These numbers will then be placed in opaque envelopes on cards and the cards will be handed out to participants in the order of arrival. The card will let the participant know which computer they should sit at. Each computer will have a different variant of the task, consistent with the allocated condition, but the experimenter will not know which computer holds which task and therefore will remain blind.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomizer, org will be used to generate sequences of 1-4, as described above.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
This is a 3 (time: pre-training; post-training and post-social stressor) 2 (CBM-A or not) x 2 (CBM-I or not) design, whereby four groups are created: CBM-A; CBM-I; CBM-AI and placebo.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We will conduct a 3 (time) x 2 (CBM-A) x 2 CBM-I ANOVAs for the primary outcome of SARS. For the secondary outcomes of interpretation and attention biases, we will conduct a 2 (time) x 2 (CBM-A) x 2 (CBM-I) ANOVAs and 2 (CBM-A) x 2(CBM-I) ANOVAs will be conducted to examine ratings generated by the coding of videotapes. On the basis of previous studies, we anticipate a moderate effect size, according to G-power to achieve 80% power with a p = 0.05, we require 30 participants per group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13208 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 293508 0
University
Name [1] 293508 0
The University of Sydney
Address [1] 293508 0
Brennan MacCallum Building A18
The University of Sydney
Camperdown NSW 2006
Country [1] 293508 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Brennan MacCallum Building A18
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 292335 0
None
Name [1] 292335 0
None
Address [1] 292335 0
None
Country [1] 292335 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294953 0
The University of Sydney HREC
Ethics committee address [1] 294953 0
Jane Foss Russell Building
The University of Sydney
Camperdown NSW 2006
Ethics committee country [1] 294953 0
Australia
Date submitted for ethics approval [1] 294953 0
20/04/2016
Approval date [1] 294953 0
Ethics approval number [1] 294953 0

Summary
Brief summary
This study will examine the relative efficacy of two variants of cognitive bias modification. these are two implicit training tasks (administered by computer), which train interpretation bias and attention bias. These two variants of CBM will be compared to each and then a combined version and a placebo group will also be included. The participants will complete the relevant training prior to a five minute social interaction task where they will be asked to describe why they are a good person. This will be videotaped. We predict that CBM-A will affect the social anxiety reported during the interaction task (rated immediately after the task), whereas CBM-I will affect the anxiety levels immediately after training. Further, we predict that the combined group will have improved outcomes overall (i.e. we predict an interaction effect between CBM-A and CBM-I.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 65610 0
Prof Louise Sharpe
Address 65610 0
Brennan MacCallum Building A18
The University of Sydney
Camperdown NSW 2006
Country 65610 0
Australia
Phone 65610 0
+61293514558
Fax 65610 0
+61293517328
Email 65610 0
louise.sharpe@sydney.edu.au
Contact person for public queries
Name 65611 0
Prof Louise Sharpe
Address 65611 0
Brennan MacCallum Building A18
The University of Sydney 2006
Country 65611 0
Australia
Phone 65611 0
+61293514558
Fax 65611 0
+61293517328
Email 65611 0
louise.sharpe@sydney.edu.au
Contact person for scientific queries
Name 65612 0
Prof Louise Sharpe
Address 65612 0
Brennan MacCallum Building A18
The University of Sydney 2006
Country 65612 0
Australia
Phone 65612 0
+61293514558
Fax 65612 0
+6193517328
Email 65612 0
louise.sharpe@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results