Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000653864
Ethics application status
Approved
Date submitted
22/04/2021
Date registered
31/05/2021
Date last updated
27/10/2021
Date data sharing statement initially provided
31/05/2021
Date results information initially provided
27/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emotional Working Memory Training as a Potential Treatment for Social Anxiety Disorder
Scientific title
Emotional Working Memory Training as a Potential Treatment for Social Anxiety Disorder (Stand-Alone Treatment) in Adults
Secondary ID [1] 303951 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 321545 0
Elevated levels of social anxiety 321546 0
Condition category
Condition code
Mental Health 319294 319294 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Emotional Working Memory Training task (eWMT) is a dual n-back task (Schweizer et al., 2011) that requires participants to monitor visual stimuli on a screen (e.g. negative emotional faces, such as angry, sad, fearful faces) and auditory stimuli through a speaker (e.g., negative emotional words such as rape, evil) simultaneously. eWMT is designed to target mental control over emotional stimuli (du Toit et al., 2020; Schweizer, 2011). Participants completing the eWMT will complete 15 eWMT sessions (20-minutes each) over a three-week period in their own homes using their own mobile phones. Once each session of training is completed, the data from the participant's mobile phone is uploaded to a secure database, which can be downloaded by the researcher to monitor training completion and training progress.
Intervention code [1] 320258 0
Treatment: Other
Comparator / control treatment
The internet based Cognitive Behavioural Therapy programme (iCBT) is a self-guided programme that goes by the name THIS WAY UP (TWU) and was developed by Clinical Research Unit for Anxiety and Depression (CRUfAD, 2020). There are six modules specifically for social anxiety, which include online lessons and homework assignments (Williams et al., 2014). Participants who are to complete iCBT programme will be asked to complete the programme within 42 days and asked to complete one module per 7-day period (Williams et al., 2014). They will complete the programme in their own homes using their own electronic devices (e.g., computer).

The iCBT modules cover the topics:
- Social Anxiety Explained
- Tackling Avoidance with Exposure
- Troubleshooting Exposure
- Unhelpful Thinking Styles
- Thought Challenging and Social Skills
- Relapse Prevention and Summary

Lessons range from 15 minutes to 30 minutes, starting with the longest lesson and getting shorter over the weeks; and the readings and homework tasks range in length from 5 pages to 18 pages.

The online lessons are presented in a comic book style where the stories of two characters, Jack and Kat, can be followed and how they manage their social anxiety disorder.

The researcher will monitor the participants progress through the iCBT course online via the clinician's account in TWU.
Control group
Active

Outcomes
Primary outcome [1] 327176 0
Social anxiety symptoms as measured by the Social Interaction Anxiety Scale.
Timepoint [1] 327176 0
Baseline, which is pre-intervention (i.e., eWMT or iCBT) and post-intervention (i.e., after a full course of eWMT or iCBT)
Primary outcome [2] 327588 0
Social anxiety symptoms as measured by the Social Phobia Scale.
Timepoint [2] 327588 0
Baseline, which is pre-intervention (i.e., eWMT or iCBT) and post-intervention (i.e., after a full course of eWMT or iCBT)
Secondary outcome [1] 394411 0
Kessler 10 (K10) to assess for anxiety and depressive symptoms.
Timepoint [1] 394411 0
Baseline, and weekly throughout the study following completion of the week's required activities.

Eligibility
Key inclusion criteria
Adult individuals with elevated levels of social anxiety, as determined by the screening measures of social anxiety (based on empirically based cut-off score); and who are fluent in written and spoken English.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will only be excluded if they have problems requiring immediate attention. This includes high risk of suicide, severe substance abuse or dependence, and/or florid psychosis.
The use of pharmacotherapy and/or psychotherapy will be allowed.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/05/2021
Date of last participant enrolment
Anticipated
19/07/2021
Actual
16/07/2021
Date of last data collection
Anticipated
11/09/2021
Actual
9/09/2021
Sample size
Target
42
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308334 0
University
Name [1] 308334 0
Western Sydney University
Country [1] 308334 0
Australia
Primary sponsor type
Individual
Name
Simone du Toit
Address
Western Sydney University
Bankstown Campus
Horsley Rd &, Bullecourt Ave, Milperra NSW 2214
Country
Australia
Secondary sponsor category [1] 309147 0
Individual
Name [1] 309147 0
Quincy Wong
Address [1] 309147 0
Western Sydney University
Penrith Campus
Second Ave
Kingswood NSW 2747
Country [1] 309147 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308309 0
Western Sydney University Human Ethics Committee
Ethics committee address [1] 308309 0
Western Sydney University Human Research Ethics Committee
Research Engagement, Development and Innovation (REDI)
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 308309 0
Australia
Date submitted for ethics approval [1] 308309 0
06/04/2021
Approval date [1] 308309 0
12/04/2021
Ethics approval number [1] 308309 0
H13830

Summary
Brief summary
The overall aim of this research is to test whether Emotional Working Memory Training (eWMT) can be used as a form of treatment for Social Anxiety Disorder (SAD) symptoms. eWMT will be compared with the treatment outcomes of internet-based Cognitive Behavioural Therapy (iCBT; eWMT vs iCBT). An initial pilot study testing the methodology of this experimental study with a mixed non-clinical and clinical sample has already been completed. The experimental study will also contain individuals diagnosed with SAD and elevated levels of social anxiety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110254 0
Ms Simone du Toit
Address 110254 0
Western Sydney University
Bankstown Campus
Horsley Rd &, Bullecourt Ave, Milperra NSW 2214
Country 110254 0
Australia
Phone 110254 0
+61 404 028 902
Fax 110254 0
Email 110254 0
13585251@student.westernsydney.edu.au
Contact person for public queries
Name 110255 0
Ms Simone du Toit
Address 110255 0
Western Sydney University
Bankstown Campus
Horsley Rd &, Bullecourt Ave, Milperra NSW 2214
Country 110255 0
Australia
Phone 110255 0
+61 492818777
Fax 110255 0
Email 110255 0
13585251@student.westernsydney.edu.au
Contact person for scientific queries
Name 110256 0
Ms Simone du Toit
Address 110256 0
Western Sydney University
Bankstown Campus
Horsley Rd &, Bullecourt Ave, Milperra NSW 2214
Country 110256 0
Australia
Phone 110256 0
+61 404 028 902
Fax 110256 0
Email 110256 0
13585251@student.westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.