Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000797875
Ethics application status
Approved
Date submitted
22/04/2021
Date registered
24/06/2021
Date last updated
12/10/2021
Date data sharing statement initially provided
24/06/2021
Type of registration
Prospectively 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 (Adjunct to Cognitive Behavioural Therapy (CBT)) in Adults
Secondary ID [1] 301766 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 318230 0
Elevated levels of social anxiety 321651 0
Condition category
Condition code
Mental Health 316242 316242 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.

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 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.

The iCBT programme is designed to start the day after the last session of brain training.

Participants in this condition with receive the eWMT and then the iCBT.
Intervention code [1] 318060 0
Treatment: Other
Comparator / control treatment
The Feature Match Training task (FMT) is a non-working memory-dependent control task (Schweizer et al., 2011). It is referred to as brain training, and it utilises the same emotional visual stimuli (e.g., faces) as the eWMT task and, according to Schweizer et al. (2011), places minimal stress on working memory resources. It differs from eWMT, as eWMT is designed to increase mental control over emotional stimuli via working memory and attentional processes (du Toit et al., 2020; Schweizer, 2011). Participants who are to complete the control training will complete 15 FMT 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.

Participants in this condition with receive the FMT and then the iCBT programme as described in the intervention(s)/exposure section above.
Control group
Active

Outcomes
Primary outcome [1] 327258 0
Social anxiety symptoms as measured by the Social Interaction Anxiety Scale.
Timepoint [1] 327258 0
Baseline/pre-brain training sessions; post-brain training sessions; and post i-CBT programme.
Primary outcome [2] 327259 0
Attentional focus during iCBT as measured by the Attentional Focus Questionnaire - Interaction
Timepoint [2] 327259 0
Immediately after every iCBT lesson
Primary outcome [3] 327260 0
Social anxiety symptomatology (i.e., cognitive, emotional, behavioural, physiological) as measured by a daily diary (DD) containing items that measure the sub-facets of symptoms. The DD is a collection of 18 items taken from existing self-report questionnaires and items created for this study. The items taken from existing questionnaires (12 items), were selected based on their high factor loadings on the symptoms facets that are of interest in this study. The pre-existing measures are:

- Anticipatory Processing Questionnaire (Vassilopoulos, 2004)
- Attentional Focus Questionnaire (Rapee & Abbott, 2007)
- Peak Anxiety Rating Scale (du Toit et al., 2020)
- Extended Post-Event Processing Questionnaire (Wong, 2015)
Timepoint [3] 327260 0
Every day of the brain training intervention at 6pm, regardless of if training had been completed for the day (i.e., some participants might choose to complete their training sessions at night)
Secondary outcome [1] 394379 0
Engagement with iCBT intervention as measured by the iCBT Weekly Survey
Timepoint [1] 394379 0
One week after each iCBT lesson has been completed
Secondary outcome [2] 394435 0
Kessler 10 (K10) to assess for anxiety and depressive symptoms
Timepoint [2] 394435 0
Baseline, and weekly throughout the study following completion of the week's required activities (i.e., weekly during the brain training phase, and weekly prior to each iCBT lesson)
Secondary outcome [3] 395730 0
Skills used to manage social anxiety symptoms measured by the iCBT Weekly Survey
Timepoint [3] 395730 0
One week after each iCBT lesson has been completed
Secondary outcome [4] 395731 0
Social anxiety symptom levels as measured by the iCBT Weekly Survey
Timepoint [4] 395731 0
One week after each iCBT lesson has been completed
Secondary outcome [5] 396306 0
Attentional focus during iCBT as measured by the CBT Quiz (the quiz is an indirect measure of attentional focus, and is a Primary Outcome)
Timepoint [5] 396306 0
Immediately after every iCBT lesson
Secondary outcome [6] 396307 0
Social anxiety symptoms as measured by the Social Phobia Scale (Primary Outcome)
Timepoint [6] 396307 0
Baseline/pre-brain training sessions; post-brain training sessions; and post i-CBT programme.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Both groups receive a different type of brain training at the start of the study (i.e., eWMT or FMT), but will receive the same iCBT programme at the end of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/10/2021
Actual
Date of last participant enrolment
Anticipated
26/11/2021
Actual
Date of last data collection
Anticipated
28/01/2022
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306195 0
University
Name [1] 306195 0
Western Sydney University
Country [1] 306195 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] 306669 0
Individual
Name [1] 306669 0
Quincy Wong
Address [1] 306669 0
Western Sydney University
Penrith Campus
Second Ave
Kingswood NSW 2747
Country [1] 306669 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306406 0
Western Sydney University Human Ethics Committee
Ethics committee address [1] 306406 0
Western Sydney University Human Research Ethics Committee
Research Engagement, Development and Innovation (REDI)
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 306406 0
Australia
Date submitted for ethics approval [1] 306406 0
06/04/2021
Approval date [1] 306406 0
12/04/2021
Ethics approval number [1] 306406 0
H13830

Summary
Brief summary
The overall aim of this research is to test whether brain training can be used as an adjunct to CBT in treating Social Anxiety Disorder (SAD) symptoms. In this study, two forms of brain training will be compared, and both will be administered before a course of 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 103774 0
Ms Simone du Toit
Address 103774 0
Western Sydney University
Bankstown Campus
Horsley Rd &, Bullecourt Ave, Milperra NSW 2214
Country 103774 0
Australia
Phone 103774 0
+61 404 028 902
Fax 103774 0
Email 103774 0
[email protected]
Contact person for public queries
Name 103775 0
Ms Simone du Toit
Address 103775 0
Western Sydney University
Bankstown Campus
Horsley Rd &, Bullecourt Ave, Milperra NSW 2214
Country 103775 0
Australia
Phone 103775 0
+61 492818777
Fax 103775 0
Email 103775 0
[email protected]
Contact person for scientific queries
Name 103776 0
Ms Simone du Toit
Address 103776 0
Western Sydney University
Bankstown Campus
Horsley Rd &, Bullecourt Ave, Milperra NSW 2214
Country 103776 0
Australia
Phone 103776 0
+61 404 028 902
Fax 103776 0
Email 103776 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


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.