Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001679178
Ethics application status
Approved
Date submitted
21/11/2019
Date registered
29/11/2019
Date last updated
3/06/2021
Date data sharing statement initially provided
29/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Single-session 360 video virtual reality exposure therapy for public speaking anxiety: a randomised controlled trial
Scientific title
A randomised controlled trial to compare the efficacy of 360 video virtual reality exposure therapy versus waitlist control on public speaking anxiety in adults
Secondary ID [1] 299869 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public speaking anxiety 315279 0
Social anxiety 315280 0
Condition category
Condition code
Mental Health 313576 313576 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 an Oculus Rift headset. Psychoeducational material involves a 5 minute explanation delivered by a research assistant to the participant, explaining 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. There will be a brief break between each speech. Testing will be conducted by a research assistant face-to-face in a university research lab. Psychoeducational material, virtual reality environments, experimenter instructions and speech topics will be standardised across participants. We will not be audio or video recording to evaluate treatment fidelity.
Intervention code [1] 316134 0
Behaviour
Intervention code [2] 316135 0
Treatment: Other
Comparator / control treatment
Participants will observe a series of neutral virtual reality environments, presented through 360 videos in an Oculus Rift headset. Neutral environments will be 360 video recordings of locations without an audience (e.g. an empty office cubicle). Participants will be instructed to merely observe each environment; they will not be making speeches. Psychoeducational material will not be provided. Participants will observe 5 different environments for 2 minutes each, for a total of 10 minutes in virtual reality.
Control group
Active

Outcomes
Primary outcome [1] 322036 0
Change in public speaking anxiety as measured by the Public Speaking Anxiety Scale (Bartholomay & Houlihan, 2016)
Timepoint [1] 322036 0
Immediately pre-intervention and 2 weeks post-intervention
Primary outcome [2] 322037 0
Change in social anxiety, as measured by the Liebowitz Social Anxiety Scale (Liebowitz 1987)
Timepoint [2] 322037 0
Immediately pre-intervention and 2 weeks post-intervention
Secondary outcome [1] 377122 0
Level of skin conductance (measured in microsiemens), as measured by Equivital Lifemonitor
Timepoint [1] 377122 0
During intervention
Secondary outcome [2] 377123 0
Change in heart rate (beats per minute) as measured by Equivital Lifemonitor
Timepoint [2] 377123 0
During intervention
Secondary outcome [3] 377124 0
Sense of presence in the virtual reality, as measured by the Presence Questionnaire (adapted from Witmer & Singer, 1998)
Timepoint [3] 377124 0
Immediately post-intervention
Secondary outcome [4] 377125 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 [4] 377125 0
Immediately post-intervention
Secondary outcome [5] 377126 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 [5] 377126 0
Baseline, during intervention and immediately post-intervention
Secondary outcome [6] 377127 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] 377127 0
2 weeks post-intervention
Secondary outcome [7] 377128 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 [7] 377128 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
18 Years
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)
Black filled cells on excel spreadsheet
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with random sized blocks, generated via randomiser 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= 0.8. Expected effect sizes was estimated from existing literature on virtual reality interventions for public speaking anxiety.

Mixed and 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
29/11/2019
Actual
27/11/2019
Date of last participant enrolment
Anticipated
18/12/2019
Actual
2/03/2020
Date of last data collection
Anticipated
5/01/2020
Actual
26/03/2020
Sample size
Target
30
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304331 0
University
Name [1] 304331 0
University of New South Wales (UNSW)
Country [1] 304331 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] 304576 0
None
Name [1] 304576 0
N/A
Address [1] 304576 0
N/A
Country [1] 304576 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304782 0
UNSW Human Research Ethics Commitee
Ethics committee address [1] 304782 0
Ethics committee country [1] 304782 0
Australia
Date submitted for ethics approval [1] 304782 0
Approval date [1] 304782 0
09/01/2017
Ethics approval number [1] 304782 0

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

Contacts
Principal investigator
Name 98182 0
A/Prof Jill Newby
Address 98182 0
Room 1302, Matthews Building, University of New South Wales
UNSW, Sydney, NSW 2052
Country 98182 0
Australia
Phone 98182 0
+61 2 93853425
Fax 98182 0
Email 98182 0
[email protected]
Contact person for public queries
Name 98183 0
Ian Li
Address 98183 0
Level 13, Matthews Building, University of New South Wales
UNSW, Sydney, NSW 2052
Country 98183 0
Australia
Phone 98183 0
+61 420925293
Fax 98183 0
Email 98183 0
[email protected]
Contact person for scientific queries
Name 98184 0
Jill Newby
Address 98184 0
Room 1302, Matthews Building, University of New South Wales
UNSW, Sydney, NSW 2052
Country 98184 0
Australia
Phone 98184 0
+61 2 93853425
Fax 98184 0
Email 98184 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.