Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001196235
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
18/07/2018
Date last updated
15/09/2020
Date data sharing statement initially provided
15/09/2020
Date results information initially provided
15/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of training mental control of emotional information on individuals with elevated social anxiety
Scientific title
The effect of emotional working memory (WM) training on individuals with elevated social anxiety
Secondary ID [1] 295499 0
None
Universal Trial Number (UTN)
U1111-1217-0560
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social anxiety 308766 0
Condition category
Condition code
Mental Health 307699 307699 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is working memory (WM) training using emotional stimuli. The training utilises a dual n-back task delivered on a computer via the internet to an individual participant, and the task has been designed to improve the mental control of emotional information. Participants will be required to simultaneously monitor visual stimuli on the computer screen (negative emotional faces) and auditory stimuli through earphones (negative emotional words). Participants will be required to indicate via button presses whether presented visual stimuli match previously presented visual stimuli n stimuli presentations back, and a similar requirement will apply to the auditory stimuli. When participants successfully master n = 1, the task increases in difficulty to n = 2, and so forth. In the current study, there will be six 10-minute training sessions, with one session per day over 6 consecutive days (with the exception of weekends). Each training session will be conducted in a testing room at Western Sydney University. A researcher trained to deliver the training task will administer the task to participants. Adherence will be monitored by the researcher in terms of the number of training sessions completed.
Intervention code [1] 301819 0
Treatment: Other
Comparator / control treatment
The comparator will be a control training task. The control training task will be a matching task delivered on a computer via the internet to an individual participant. Participants will be required to indicate via button press whether a pattern of pictures of negative emotional faces presented on the computer screen matches another pattern of pictures of negative emotional faces presented simultaneously on the screen. The pictures of negative emotional faces used in the control training task will be the same as those used in the WM training task. In the current study, there will be six 10-minute training sessions, with one session per day over 6 consecutive days (with the exception of weekends). Each training session will be conducted in a testing room at Western Sydney University. A researcher trained to deliver the training task will administer the task to participants. Adherence will be monitored by the researcher in terms of the number of training sessions completed.
Control group
Active

Outcomes
Primary outcome [1] 306690 0
Social-evaluative cognitive processes, as measured by the Anticpatory Processing Questionnaire, Attentional Focus Questionnaire, and Extended Post-event Processing Questionnaire
Timepoint [1] 306690 0
Immediately pre-training, immediately post-training
Primary outcome [2] 306691 0
Attentional engagement with negative social stimuli, and attentional disengagement with negative social stimuli, as measured by a modified dot probe task
Timepoint [2] 306691 0
Immediately pre-training, immediately post-training
Primary outcome [3] 306692 0
Cognitive empathy, as measured by emotional slider scales (0-100) in response to short video clips of individuals describing emotional events
Timepoint [3] 306692 0
Immediately pre-training, immediately post-training
Secondary outcome [1] 349264 0
Primary Outcome: Affective empathy, as measured by emotional slider scales (0-100) in response to short video clips of individuals describing emotional events
Timepoint [1] 349264 0
Immediately pre-training, immediately post-training
Secondary outcome [2] 349431 0
Working memory, as measured by the Digit span test
Timepoint [2] 349431 0
Immediately pre-training, immediately post-training
Secondary outcome [3] 349432 0
Anxiety levels during a talking task, as measured by a 11-point Likert scale
Timepoint [3] 349432 0
Immediately pre-training, immediately post-training

Eligibility
Key inclusion criteria
(a) aged 18 years or older
(b) elevated social anxiety as indicated by a score of 7 or higher on the short form Social Interaction Anxiety Scale or 2 or higher on the short form Social Phobia Scale.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
The method of alllocation concealment will involve contacting the holder of the allocation schedule who is not involved with the determination of subject eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will occur based on an online random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2018
Actual
23/07/2018
Date of last participant enrolment
Anticipated
14/09/2018
Actual
29/08/2018
Date of last data collection
Anticipated
21/09/2018
Actual
4/09/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300084 0
University
Name [1] 300084 0
Western Sydney University
Country [1] 300084 0
Australia
Primary sponsor type
Individual
Name
Quincy Wong
Address
Western Sydney University
Penrith Campus
Second Ave
Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 299486 0
None
Name [1] 299486 0
Address [1] 299486 0
Country [1] 299486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300932 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 300932 0
Western Sydney University Human Research Ethics Committee
Research Engagement, Development and Innovation (REDI)
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 300932 0
Australia
Date submitted for ethics approval [1] 300932 0
22/03/2018
Approval date [1] 300932 0
27/04/2018
Ethics approval number [1] 300932 0
H12660

Summary
Brief summary
Working memory (WM) training using emotional stimuli has been designed to improve the mental control of emotional information. The aim of this project is to test whether individuals with elevated social anxiety would benefit from WM training with emotional stimuli. It is anticipated that individuals with elevated social anxiety who engage in a WM training task with emotional stimuli, relative to those who engage in a control training task, will exhibit: (a) reduced theory-based social-evaluative processes (anticipatory processing, self-focused attention, post-event processing), b) reduced attentional bias towards negative social stimuli, and (c) improved cognitive and affective empathy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85322 0
Dr Quincy Wong
Address 85322 0
Western Sydney University
Penrith Campus
Second Ave
Kingswood NSW 2747
Country 85322 0
Australia
Phone 85322 0
+61 2 4736 0266
Fax 85322 0
Email 85322 0
[email protected]
Contact person for public queries
Name 85323 0
Dr Quincy Wong
Address 85323 0
Western Sydney University
Penrith Campus
Second Ave
Kingswood NSW 2747
Country 85323 0
Australia
Phone 85323 0
+61 2 4736 0266
Fax 85323 0
Email 85323 0
[email protected]
Contact person for scientific queries
Name 85324 0
Dr Quincy Wong
Address 85324 0
Western Sydney University
Penrith Campus
Second Ave
Kingswood NSW 2747
Country 85324 0
Australia
Phone 85324 0
+61 2 4736 0266
Fax 85324 0
Email 85324 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
There is currently no plan to make individual participant data publicly available. However, individuals interested in the individual participant data may contact the Principal investigator with any enquiries.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes du Toit, S. A., Kade, S. A., Danielson, C. T., Sch... [More Details]

Documents added automatically
No additional documents have been identified.