Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000551190
Ethics application status
Approved
Date submitted
3/04/2019
Date registered
9/04/2019
Date last updated
11/03/2020
Date data sharing statement initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of one-session 360 video virtual reality exposure therapy for public speaking anxiety
Scientific title
A randomised control trial of 360 video virtual reality exposure therapy for public speaking anxiety
Secondary ID [1] 297875 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public Speaking Anxiety 312247 0
social anxiety 312256 0
Condition category
Condition code
Mental Health 310794 310794 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo one 20 minute session of virtual reality exposure therapy. Participants will receive psychoeducational material and then make a ten 2-minute impromptu speeches in virtual reality environments, graded in difficulty, presented through 360 videos in a Samsung Gear VR headset. Psychoeducational material involves a 5 minute explanation delivered by an undergraduate student to the participant, explaining about anxiety, how avoidance perpetuates anxiety, and about how exposure therapy works. Virtual environments will be 360 video recordings of audiences either listening or ignoring the participant, and will be graded/ranked in difficulty, with the participant starting by viewing audiences of 1-2 participants, with the highest level viewing a full audience in an auditorium within the VR headset. There will be a brief break between each speech. A student will deliver the instructions to the participant, and delivered in a university research testing room setting.
Intervention code [1] 314106 0
Behaviour
Intervention code [2] 314126 0
Treatment: Other
Comparator / control treatment
Participants will undergo one 20 minute session of virtual reality exposure therapy. They will receive psychoeducational information and then make ten 2-minute impromptu speeches in neutral virtual reality environments, prensented through 360 videos in a Samsung Galaxy VR headset. Neutral environments will be 360 video recordings of locations without an audience (e.g. an empty office cubicle).
Control group
Active

Outcomes
Primary outcome [1] 319639 0
Change in public speaking anxiety as measured by the Public Speaking Anxiety Scale (Bartholomay & Houlihan, 2016)
Timepoint [1] 319639 0
Pre-intervention and 2 weeks post-intervention
Secondary outcome [1] 368980 0
Speech quality during a Behavioural Avoidance Task for public speaking, as measured by a scale developed by Rapee and Lim (1992)
Timepoint [1] 368980 0
Immediately post-intervention
Secondary outcome [2] 368981 0
% change in skin conductance, as measured by an Empatica e4 wristband.
Timepoint [2] 368981 0
During intervention
Secondary outcome [3] 368982 0
% change in blood volume pulse as measured by an Empatica e4 wristband
Timepoint [3] 368982 0
During intervention
Secondary outcome [4] 368983 0
Sense of presence in the virtual reality, as measured by the Presence Questionnaire (adapted from Witmer & Singer, 1998)
Timepoint [4] 368983 0
Immediately post-intervention
Secondary outcome [5] 368984 0
Side effects of virtual reality exposures, as measured by the Simulator Sickness Questionnaire (Kennedy, Lane, Berbaum, & Lilienthal, 1993. Side effects may include nausea or dizziness.
Timepoint [5] 368984 0
Immediately post-intervention
Secondary outcome [6] 368985 0
Number of self-conducted exposures to public speaking situations conducted over the past week, as rated by a one-item self-report question (i.e., how many times have you conducted self exposures to public speaking situations in the past week?).
Timepoint [6] 368985 0
2 weeks post-intervention
Secondary outcome [7] 368986 0
Subjective units of distress (self-rated from 1-10). This outcome is assessed on a one-item scale: how distressed are you feeling now (on a scale from 1-10, where 1 = not at all, and 10 = extremely distressed).
Timepoint [7] 368986 0
Baseline, during intervention and immediately post-intervention
Secondary outcome [8] 368987 0
Likelihood of recommending exposure program to a friend (measured out of 10). This measure is assessed with a one-item likert scale: how likely are you to recommend this course to a friend, on a scale from 1-10, where 1 = not at all, and 10 = very likely).
Timepoint [8] 368987 0
Immediately post-intervention
Secondary outcome [9] 369013 0
Change in social anxiety, as measured by the Liebowitz Social Anxiety Scale (Liebowitz 1987)
Timepoint [9] 369013 0
Pre-intervention and 2 weeks post-intervention
Secondary outcome [10] 369014 0
Speech duration (in seconds) during a Behavioural Avoidance Task (based on Amir et. al., 2008) for public speaking
Timepoint [10] 369014 0
Immediately post-intervention

Eligibility
Key inclusion criteria
At least moderate public speaking anxiety (> 52 on Public Speaking Anxiety Scale)
Do not experience motion sickness
Willing to undergo virtual reality exposures
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Experience motion sickness
Currently receiving treatment for public speaking 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)
Opaque Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random number generator on the internet
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined with a power analysis, using a power of 0.8, and expected effect size of Cohen's d= 0.6. Expected effect sizes was estimated from existing literature on virtual reality interventions for public speaking anxiety.

Repeated measures analyses of variance (ANOVAs), and independent samples t-tests will be used to evaluate the primary and secondary measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/04/2019
Actual
11/04/2019
Date of last participant enrolment
Anticipated
26/07/2019
Actual
13/08/2019
Date of last data collection
Anticipated
9/08/2019
Actual
27/08/2019
Sample size
Target
90
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302400 0
University
Name [1] 302400 0
University of New South Wales (UNSW)
Country [1] 302400 0
Australia
Primary sponsor type
University
Name
UNSW (University of New South Wales)
Address
Level 15 Mathews Building
UNSW
Kensington
NSW 2052, Australia
Country
Australia
Secondary sponsor category [1] 302289 0
None
Name [1] 302289 0
N/A
Address [1] 302289 0
N/A
Country [1] 302289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303070 0
UNSW Human Research Ethics Commitee
Ethics committee address [1] 303070 0
Ethics committee country [1] 303070 0
Australia
Date submitted for ethics approval [1] 303070 0
Approval date [1] 303070 0
09/01/2017
Ethics approval number [1] 303070 0
HC16789

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

Contacts
Principal investigator
Name 92362 0
Dr Jill Newby
Address 92362 0
Room 1302, Matthews Building, University of New South Wales
UNSW, Sydney 2052
Country 92362 0
Australia
Phone 92362 0
+61 2 93853425
Fax 92362 0
Email 92362 0
[email protected]
Contact person for public queries
Name 92363 0
Ian Li
Address 92363 0
Level 13, Matthews Building, University of New South Wales
UNSW, Sydney 2052
Country 92363 0
Australia
Phone 92363 0
+61 420925293
Fax 92363 0
Email 92363 0
[email protected]
Contact person for scientific queries
Name 92364 0
Jill Newby
Address 92364 0
Room 1302, Matthews Building, University of New South Wales
UNSW, Sydney 2052
Country 92364 0
Australia
Phone 92364 0
+61 2 93853425
Fax 92364 0
Email 92364 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.