Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000801112
Ethics application status
Approved
Date submitted
21/05/2019
Date registered
31/05/2019
Date last updated
31/05/2019
Date data sharing statement initially provided
31/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of training mental control of emotional information on individuals with elevated social anxiety: Further examination of self-related and cognitive outcomes
Scientific title
The effect of emotional working memory (WM) training on individuals with elevated social anxiety: Further examination of self-related and cognitive outcomes
Secondary ID [1] 298292 0
None
Universal Trial Number (UTN)
U1111-1233-8102
Trial acronym
Linked study record
This study builds on the original study (ACTRN12618001196235). This study is a new study, and seeks to further examine the effect of working memory training with emotional stimuli on new dependent variables.

Health condition
Health condition(s) or problem(s) studied:
social anxiety 312918 0
Condition category
Condition code
Mental Health 311412 311412 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 or an app 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. 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] 314528 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 or an app 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. 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] 320131 0
Social-evaluative self-beliefs, as measured by the State Core Beliefs Questionnaire (CBQ)
Timepoint [1] 320131 0
Immediately pre-training, immediately post-training
Primary outcome [2] 320132 0
Social-evaluative self-beliefs, as measured by the Self-Beliefs Related to Social Anxiety (SBSA) Scale
Timepoint [2] 320132 0
Immediately pre-training, immediately post-training
Primary outcome [3] 320133 0
Self-esteem, as measured by the State Rosenberg Self-Esteem Scale
Timepoint [3] 320133 0
Immediately pre-training, immediately post-training
Secondary outcome [1] 370664 0
Self-esteem, as measured by the Implicit Associations Test (IAT)
Timepoint [1] 370664 0
Immediately pre-training, immediately post-training
Secondary outcome [2] 370665 0
Cognitive flexibility, as measured by the Emotional Wisconsin Card Sorting Task (EWCST)
Timepoint [2] 370665 0
Immediately pre-training, immediately post-training
Secondary outcome [3] 370756 0
Thought generation, as measured by a Cognitive Restructuring Task
Timepoint [3] 370756 0
Immediately pre-training, immediately post-training
Secondary outcome [4] 370757 0
Anxiety, as measured by the brief State-Trait Anxiety Inventory (STAI)
Timepoint [4] 370757 0
Immediately pre-training, immediately post-training
Secondary outcome [5] 370758 0
Anxiety, as measured by the Peak Anxiety Rating Scale (PARS)
Timepoint [5] 370758 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2019
Actual
Date of last participant enrolment
Anticipated
14/09/2019
Actual
Date of last data collection
Anticipated
21/09/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302835 0
University
Name [1] 302835 0
Western Sydney University
Country [1] 302835 0
Australia
Primary sponsor type
Individual
Name
Quincy Wong
Address
Quincy Wong
Western Sydney University
Kingswood Campus
Second Ave
Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 302781 0
None
Name [1] 302781 0
Address [1] 302781 0
Country [1] 302781 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303413 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 303413 0
Ethics committee country [1] 303413 0
Australia
Date submitted for ethics approval [1] 303413 0
17/04/2019
Approval date [1] 303413 0
14/05/2019
Ethics approval number [1] 303413 0
H12660

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

Contacts
Principal investigator
Name 93590 0
Dr Quincy Wong
Address 93590 0
Western Sydney University
Kingswood Campus
Second Ave
Kingswood NSW 2747
Country 93590 0
Australia
Phone 93590 0
+61 2 4736 0080
Fax 93590 0
Email 93590 0
[email protected]
Contact person for public queries
Name 93591 0
Quincy Wong
Address 93591 0
Western Sydney University
Kingswood Campus
Second Ave
Kingswood NSW 2747
Country 93591 0
Australia
Phone 93591 0
+61 2 4736 0080
Fax 93591 0
Email 93591 0
[email protected]
Contact person for scientific queries
Name 93592 0
Quincy Wong
Address 93592 0
Western Sydney University
Kingswood Campus
Second Ave
Kingswood NSW 2747
Country 93592 0
Australia
Phone 93592 0
+61 2 4736 0080
Fax 93592 0
Email 93592 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.