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Trial registered on ANZCTR


Registration number
ACTRN12617001096347
Ethics application status
Approved
Date submitted
19/07/2017
Date registered
27/07/2017
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Date results information initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
One session Virtual reality exposure therapy for specific phobias of blood, injection and injury
Scientific title
Randomised controlled trial of one session virtual reality exposure therapy for blood injection injury phobias
Secondary ID [1] 292471 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Specific phobia (anxiety disorder) 304086 0
Condition category
Condition code
Mental Health 303423 303423 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One session virtual reality exposure therapy (VRET).

During VRET, participants will be asked to wear a virtual reality headset (e..g, Oculus Rift or Samsung Gear VR) and view virtual environments that depict feared situations including needles, dentists, blood, wounds, injections and injury in a graded order (from least anxiety-provoking to most anxiety-provoking). Duration of VRET session is approximately 90 minutes, but can range up to 120 minutes. Virtual environments depict the following situations: medical office, dentist office, blood collection centre, nurses's office for wound dressing, and nurse's office for injections. Environments are graded as easy, medium or hard, and the participant can select either to observe another patient in the situation, or take the 1st person perspective of the patient.. The order is tailored to the specific concerns of the participant, who will choose the order in which the scenarios are delivered after the experimenter has explained the scenarios to them. Typically, the participant would be required to start at the easy step, and then move to the medium step when either their anxiety levels have reduced, or they are ready, and finally the hard step.. Each scenario lasts around 3-5 minutes, and the participant can stay in the scenario for as long as they choose, and/or repeat the scenario if they wish.
Intervention code [1] 298652 0
Behaviour
Intervention code [2] 298689 0
Treatment: Other
Comparator / control treatment
Waiting list control group (WLC), who will be provided the opportunity to receive the intervention 3 months after enrolment.
Control group
Active

Outcomes
Primary outcome [1] 302808 0
Changes in medical fears (blood injection injury fears) on the Medical Fear Survey
Timepoint [1] 302808 0
Administered at baseline (T1), one week after the intervention (T2), and 3 months follow-up (T3)
Secondary outcome [1] 337095 0
Changes in blood injection injury fears according to the Multidimensional Blood Phobia Inventory
Timepoint [1] 337095 0
Administered at baseline (T1), one week after the intervention (T2), and 3 months follow-up (T3)
Secondary outcome [2] 337096 0
Diagnosis of specific phobia of blood-injection-injury according to the Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5)
Timepoint [2] 337096 0
Administered at Baseline (T1) and 3-month follow-up (T3)
Secondary outcome [3] 337097 0
Changes in severity of Blood-Injection-Injury phobia according to clinician severity ratings (CSR) on the Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5)
Timepoint [3] 337097 0
Administered at Baseline (T1) and 3-month follow-up (T3)
Secondary outcome [4] 337098 0
Changes in depression, anxiety and stress (psychological distress) according to the Depression Anxiety Stress Scales (DASS-21)
Timepoint [4] 337098 0
Administered at baseline (T1), one week after the intervention (T2), and 3 months follow-up (T3)
Secondary outcome [5] 337099 0
Changes in disgust sensitivity according to the Disgust Propensity Scale and Sensitivity Revised (DSPR) scale
Timepoint [5] 337099 0
Administered at baseline (T1), one week after the intervention (T2), and 3 months follow-up (T3)
Secondary outcome [6] 337100 0
Changes in anxiety sensitivity according to the Anxiety Sensitivity Scale (ASI-3)
Timepoint [6] 337100 0
Administered at Baseline (T1), one week after baseline (T2) and 3-month follow-up (T3)
Secondary outcome [7] 337101 0
Changes in dental anxiety according to the Modified Dental Anxiety Scale (MDAS)
Timepoint [7] 337101 0
Administered at Baseline (T1), one-week after baseline (T2) and 3-month follow-up (T3).
Secondary outcome [8] 337102 0
Self-reported behaviours (receiving blood test, vaccination, injection, needle/finger prick, acupuncture/dry needling), assessed via self-report questionnaire designed for this study..
Timepoint [8] 337102 0
Administered one week after baseline (T2), and 3-month follow-up (T3)
Secondary outcome [9] 337103 0
Changes in cognition ratings according to Catastrophic Cognitions Questionnaire
Timepoint [9] 337103 0
Administered at Baseline (T1), one week after baseline (T2) and 3-month follow-up
Secondary outcome [10] 337104 0
Treatment satisfaction according to the Credibility and Expectancy Questionnaire
Timepoint [10] 337104 0
One-week after baseline (T2)
Secondary outcome [11] 337105 0
Adverse outcomes, such as unwanted side effects of virtual reality (e.g., dizziness, nausea), assessed via self-report measure designed for this study.
Timepoint [11] 337105 0
After the VRET intervention (session 1, T1)

Eligibility
Key inclusion criteria
Inclusion criteria:
• Adults aged 18 years or over
• Meet criteria for a diagnosis of specific phobia of Blood-injection-injury situations (BII Phobia) according to structured diagnostic interview (ADIS-5).


Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
* Does not meet criteria for a BII phobia (specific phobia of blood, injection, or injury)
• Severely depressed
* Currently suicidal
* Current benzodiazepine use,
• Receiving current exposure therapy.
• Experience motion sickness or
• Self-reported history of adverse responses to virtual reality (VR).

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)
Group allocation will be concealed from the interviewer until an offer of treatment made. Group allocation will not be concealed from the participant throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation numbers will be generated using random.org using simple randomisation by a
research assistant independent from the study.
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
Intention to treat linear mixed models will be used to analyse whether the VRET intervention is superior to the waiting list control group in fears of blood, injections or injury. If there is no missing data, independent samples t tests will be used to compare the groups at post-treatment and follow-up. E ect sizes (Cohen's d and their 95% confidence intervals) will be calculated to explore andcompare the size of the within-group and between-group effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16669 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 297038 0
University
Name [1] 297038 0
UNSW Sydney
Address [1] 297038 0
School of Psychology
Mathews Building
UNSW Sydney
Kensington, NSW 2052
Australia
Country [1] 297038 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
School of Psychology
Mathews Building
UNSW Sydney
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 296046 0
None
Name [1] 296046 0
N/A
Address [1] 296046 0
N/A
Country [1] 296046 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298222 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 298222 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 298222 0
Australia
Date submitted for ethics approval [1] 298222 0
13/03/2017
Approval date [1] 298222 0
17/05/2017
Ethics approval number [1] 298222 0
HC16789

Summary
Brief summary
This RCT will evaluate the acceptability and efficacy of a one-session Virtual Reality Exposure Therapy intervention targeting fears of blood, injection and injury, by comparing one-session of VRET with a waiting list control group (WLC). This study will also explore individual difference factors that predict better response to VRET, the mediators of response to VRET as well as the effect of the intervention on comorbid symptoms (e.g., depression), cognitions and emotions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76390 0
Dr Jill Newby
Address 76390 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 76390 0
Australia
Phone 76390 0
+61 (2) 9385 3425
Fax 76390 0
Email 76390 0
j.newby@unsw.edu.au
Contact person for public queries
Name 76391 0
Dr Jill Newby
Address 76391 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 76391 0
Australia
Phone 76391 0
+61 (2) 9385 3425
Fax 76391 0
Email 76391 0
j.newby@unsw.edu.au
Contact person for scientific queries
Name 76392 0
Dr Jill Newby
Address 76392 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 76392 0
Australia
Phone 76392 0
+61 (2) 9385 3425
Fax 76392 0
Email 76392 0
j.newby@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary