Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001154190
Ethics application status
Approved
Date submitted
23/06/2019
Date registered
19/08/2019
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Assertiveness Training on Social Anxiety in a Virtual Reality Setting: A Pilot
Scientific title
Effect of Assertiveness Training on Social Anxiety in a Virtual Reality Setting: A Pilot
Secondary ID [1] 298278 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 312894 0
Condition category
Condition code
Mental Health 311380 311380 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental group will be able to experience three different assertiveness skills training scenarios within the VR environment. An Oculus VR headset will be worn by participants. Individuals in the experimental group will be briefed about the nature of each scenario through a voice over explaining the scenario and the skills to practice before the scenario commences. Participants will then be directed to interact with virtual character and practice their assertiveness skills. All dialogues are pre-recorded, and participants will all go through the same dialogues to ensure a standardised environment and reduce confounds. The researcher will be able to see the dialogues on the screen during the VR exposure session, whereas participants will only see the VR environment. To ensure an immersive experience, the researcher will press spacebar to present the next line of the scripted dialogue once the participant had given a response until the scenario is completed. The VR exposure session will take approximately 15-20 minutes to complete, participants will only be exposed to one single session of the VR exposure. The researchers will be in the room to monitor adherence to the intervention.
Intervention code [1] 314550 0
Treatment: Devices
Intervention code [2] 314551 0
Behaviour
Comparator / control treatment
Participants in the controlled group will be placed in the same virtual environment where they can look around and explore, but without the opportunity to interact with virtual characters or practice their assertiveness skills.
Control group
Active

Outcomes
Primary outcome [1] 320161 0
Social anxiety
The Liebowitz Social Anxiety Scale – Self Report version (LSAS-SR; Rytwinski et al, 2009) will be used to measure social anxiety pre- and post-intervention. The LSAS-SR is a 24-item measure that assesses anxiety and avoidance across two domains: social situations and performance anxiety. Anxiety is measured on a 4-point scale (0= none; 3= severe). Avoidance is rated on a 4-point scale, (0= never, 0%; 3= usually, 67-100%). The LSAS is a widely used measure for social anxiety and demonstrates good psychometric properties, Cronbach’s a = 0.96 (Santos, Loureiro, Crippa, & Osorio, 2013).
Timepoint [1] 320161 0
Primary outcome measures will be completed by participants immediately after VR exposure.
Primary outcome [2] 320162 0
Assertiveness
The Rathus Assertiveness Schedule (RAS; Rathus, 1973) is a 30-item self-report questionnaire. It measures one’s assertiveness on a 6-point Likert scale, ranging from -3 (Very uncharacteristic of me, extremely non-descriptive) to +3 (Very characteristic of me, extremely descriptive), excluding 0. With a high positive scoring indicating high social skills. The RAS is a commonly used measure for assertiveness and has been shown to have good psychometric properties. Caballo et al. (2014) indicated that the test-retest reliability was between .76 and .83, and Cronbach’s alpha ranged between .73 and .86.
Timepoint [2] 320162 0
Primary outcome measures will be completed by participants immediately after VR exposure.
Secondary outcome [1] 370746 0
Presence
The presence questionnaire is a 13-item questionnaire, measuring effectiveness of the virtual world in engaging one’s senses (Schubert, Friedmann, & Regenbrecht, 2001). Presence is measured with three factors: spatial presence, involvement, and realism. Items are measured on a 7-point Likert scale, ranging from fully disagree to fully agree.
Timepoint [1] 370746 0
Secondary outcome measures will be completed by participants immediately after VR exposure.
Secondary outcome [2] 370747 0
Immersive
The immersive tendency questionnaire (Jerome & Witmer, 2002) is used to measure predisposition to become immersed in the virtual world. It is a 18-item measure on a 7-point scale (-3= never; 3= often), asking about one’s involvement, focus, and propensity to play and enjoy video games.
Timepoint [2] 370747 0
Secondary outcome measures will be completed by participants immediately after VR exposure.

Eligibility
Key inclusion criteria
Participants with social anxiety will be recruited from the community using a number of inclusionary and exclusionary criteria. Participants must be aged 18 to 65. To ensure a fully immersive virtual reality experience, individuals will be required to self-identified as being proficient in English in order to comprehend the self-training module and dialogues, have normal or corrected to normal vision, as well as normal hearing.

In addition, a number of screening tools will be used to determine participant eligibility, details as follows:

Motion Sickness Screening
- The MSSQ-R will be used to screen out individuals susceptible to motion sickness or simulation sickness. Individuals scoring 13 and above will be excluded due to higher chance of experiencing simulation sickness.

Social Anxiety
- The LSAS-SR will be used to measure participants’ social anxiety, Rytwinski et al. (2009) indicated a cutoff score of 60 suggest the presence of social anxiety disorder. Therefore, individuals scoring below 60 will be excluded from the study.

Assertiveness
- In order to test the effectiveness of the assertiveness training module, individuals scoring 20 and above on the RAS will be excluded due to high levels of assertiveness or aggressiveness.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The virtual environment can elicit discomfort, which may potentially confound the results and create transient harm to potential participants. There is also a theoretical risk that VR will induce seizure. Therefore individuals with a history of epilepsy, seizures, motion sickness or simulation sickness will be excluded. The current study also excludes individuals receiving concurrent psychotherapy targeting unassertiveness due to the potential of confounding results.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori power analysis using GPower 3.1, to assess the sample size needed to conduct a repeated, within-between ANOVA, with an estimated effect size of 0.25; alpha level of 0.05, and power of 0.8 indicated a sample size of 34 is needed to achieve sufficient power for the study. To allow for potential dropout and imcomplete measures, 20 participants will be recruited for each group.
The statistics software SPSS (IBM version 25) will be used to analyse the data collected from the current study. The research primarily focuses on the effect of the independent variable, the assertiveness intervention, on the two dependent variables (i.e. assertiveness and social anxiety) over time. The independent variable is a categorical variable with two groups, the control group, and the VR assertiveness training group. The dependent variables are continuous. Time is also an independent categorical variable in the current study, where both the dependent variables are measured pre-test and post-test.
Two 2 x 2 (Group [experimental/ control] x Time [pre/ post]) mixed model Analysis of Covariance (ANCOVA) on assertiveness (pre/post) and social anxiety (pre/post) will be conducted; presence and immersive tendency are included as covariates. Before conducting the ANCOVA analysis, data will be checked for outliers, testing for normality in the dependent variables, homogeneity of variance, and sphericity (Field, 2013).
A mediation analysis may be conducted depending on the results from the ANVOCA, to determine the extent to which the effect of experimental group on social anxiety is mediated by changes in assertiveness. The analyses will be conducted using process in SPSS (Hayes, 2013), which allows for testing mediation in smaller samples with covariates, by using bootstrapping techniques.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2019
Actual
Date of last participant enrolment
Anticipated
29/11/2019
Actual
Date of last data collection
Anticipated
1/01/2020
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302819 0
University
Name [1] 302819 0
ISN Psychology
Country [1] 302819 0
Australia
Primary sponsor type
University
Name
ISN Psychology
Address
R15/443 Upper Heidelberg Rd, Ivanhoe, VIC 3079
Country
Australia
Secondary sponsor category [1] 302768 0
None
Name [1] 302768 0
None
Address [1] 302768 0
None
Country [1] 302768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303402 0
ISN Psychology HREC
Ethics committee address [1] 303402 0
15/443 Upper Heidelberg Rd, Ivanhoe, VIC 3079
Ethics committee country [1] 303402 0
Australia
Date submitted for ethics approval [1] 303402 0
21/11/2018
Approval date [1] 303402 0
16/05/2019
Ethics approval number [1] 303402 0
190501

Summary
Brief summary
The proposed project is a pilot study that aims to implement virtual realtiy assertiveness training within a socially anxious population. The proposed research examines the feasibility of delivering assertiveness training within a VR environment, alongside examining the effectiveness of assertiveness training in reducing social anxiety and increasing assertiveness using this modality. Based on previous literature on VR and assertiveness, it is predicted that individuals in the virtual reality condition will show a clinically significant reduction in anxiety and increased assertiveness compared to individuals in the control condition.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 93550 0
Ms Sally Poon
Address 93550 0
ISN Psychology
R15/443 Upper Heidelberg Rd,
Ivanhoe,
VIC, 3079
Country 93550 0
Australia
Phone 93550 0
+61 477289888
Fax 93550 0
Email 93550 0
[email protected]
Contact person for public queries
Name 93551 0
Ms Marisca Gouws
Address 93551 0
ISN Psychology
R15/443 Upper Heidelberg Rd,
Ivanhoe,
VIC, 3079
Country 93551 0
Australia
Phone 93551 0
+613 8900 0000
Fax 93551 0
Email 93551 0
[email protected]
Contact person for scientific queries
Name 93552 0
Ms Marisca Gouws
Address 93552 0
ISN Psychology
R15/443 Upper Heidelberg Rd,
Ivanhoe,
VIC, 3079
Country 93552 0
Australia
Phone 93552 0
+613 8900 0000
Fax 93552 0
Email 93552 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2158Ethical approval    377623-(Uploaded-14-07-2019-13-37-15)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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