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UniVRse: VR-CBT for Students With Social Anxiety

UniVRse: Pilot Randomised Controlled Trial of Virtual Reality Cognitive Behaviour Therapy (VR-CBT) for Students With Social Anxiety

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05704868
Acronym
UniVRse
Enrollment
90
Registered
2023-01-30
Start date
2023-12-08
Completion date
2024-07-01
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety

Keywords

Social anxiety, Students, University, Virtual Reality, Cognitive Behaviour Therapy

Brief summary

The goal of this pilot randomised controlled trial is to evaluate the effectiveness of the UniVRse VR-CBT programme in students with social anxiety. The aims of this trial are: 1. To determine whether a full trial is justified; 2. To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial; 3. To address questions concerning study recruitment, retention, and acceptability. Participants will complete a baseline assessment (T0) and then be randomly allocated to receive either UniVRse VR-CBT or join the wait-list control group. UniVRse VR-CBT uses graded exposure techniques delivered using VR to help students feel more confident in university-based situations. Data will be collected post-intervention (T1) along with exit interviews to assess participant experience.

Interventions

BEHAVIORALUniVRse + TAU

UniVRse uses well-established evidence-basedcognitive behavioural therapy (CBT) techniques - specifically graded exposure - to reduce fear and worries about social situations. People work towards overcoming their anxiety in a step-by-step fashion, building up to the most feared situation. In the context of UniVRse, students will be presented with four university-based scenarios that our coproduction team identified as being the most anxiety-induing for students: 1. Attending a lecture; 2. Group work in a seminar; 3. Delivering a presentation; 4. Contributing to an online seminar. The UniVRse programme has been designed with our co-production team comprised of tirst-generation students with social anxiety, CBT therapists, and a VR design company.

Sponsors

University of Westminster
CollaboratorOTHER
University of Nottingham
CollaboratorOTHER
University of Sussex
CollaboratorOTHER
University of Surrey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For participants to be eligible to take part, they must be: * A current student at the University of Westminster; * Able to read and communicate in English; * Wanting help to feel more confident at university; * Deemed to have context-specific social anxiety as defined by a response of 'moderate' or 'often' on one of the subscales from any one of the following items from the MLSAS-SR: 5, 12, 17, and 9. These items reflect the highest level (i.e. most anxiety-invoking) of each of the four scenarios within the UniVRse programme: * Asking a question in a lecture in person * Delivering a presentation on your own in front of the class * Speaking using my mic during online seminars * Speaking up during small group discussions in person

Exclusion criteria

Persons will be excluded from the study if meet any of the following criteria: * Have photosensitive epilepsy; * Have a visual impairment that cannot be corrected with glasses; * Have a balance disorder; * Have a significant auditory impairment; * Have current and active suicidal plans; * Are currently accessing or have confirmed plans to access another psychological intervention during the course of the study. Participants will be excluded from providing a saliva sample (required for the cortisol measurement) if they meet any of the following criteria: * Are pregnant; * Currently breastfeeding; * Taking any medications; * Have any other serious medical condition; * Think that they currently have COVID-19. These participants may still participate in the wider UniVRse trial if they meet all of the aforementioned main trial inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Social Phobia Inventory (SPIN)One weekThe Social Phobia Inventory (SPIN) (Connor et al., 2000) is a 17-item questionnaire measuring social anxiety.
Modified Liebowitz Social Anxiety Scale (MLSAS-SR)One weekWe have used the LSAS-SR as the basis for developing a social anxiety scale that is specific to the university environment. The modified version of this scale has a list of different university-based situations and participants are asked the extent to which they fear and avoid each of the situations.

Secondary

MeasureTime frameDescription
Short Instrument for measuring students' Confidence with Key Skills (SICKS)One weekThe SICKS (Bray et al., 2020) assesses students' confidence in relation to a range of education-related activities.
Identification with University (IwU)One weekThe IwU (Nieuwenhuis et al., 2019) is a subscale within a broader assessment on social identity. The IwU assesses the extent to which persons perceive being a university student is consistent with their social identity.
Domain Specific Hope Scale - Social Hope (DSHS-SH) and Academic Hope (DSHS-AH) subscalesOne dayThe DSHS assesses hope in relation to a variety of life domains. There are a total of six subscales and in this study we will be utilising both the social and academic hope subscales (Sympson, 1999).
AttendanceTwo weeksThe University of Westminster has a 'tap in' system whereby students are required to use their student ID to register their attendance for all timetabled activities. These data are used to assess student attendance and identify any students at risk of disengaging.
Cortisol in saliva samplesThree daysWe will ask participants to provide 6 saliva samples a day for three consecutive days per time point i.e., 6 each at T0 on days 1, 2, and 3, and 6 each at T1 on days 1, 2, and 3 - this equates to 18 saliva samples her time point and 36 samples in total across the duration of the study per participant. We will use the samples to measure levels of the stress hormone cortisol.
Patient Health Questionnaire 9 (PHQ-9)Last 2 weeksThe PHQ-9 (Spitzer et al., 1999) measures levels of depression.
Generalised Anxiety Disorder 7 (GAD-7)Last 2 weeksDeveloped by the same research team as the PHQ-9, the GAD-7 (Spitzer et al., 2006) is a brief screening tool used in primary care to assess the severity of generalised anxiety symptoms.
The Rathus Assertiveness Schedule (RAS)One dayThe RAS (Rathus, 1973) was developed to measure general assertiveness.
Spreitzer's Psychological Empowerment Scale (SPES)One weekThe SPES (Spreitzer, 1995) assesses assertiveness in a specific context in terms of feeling empowered.
Rosenberg self-esteem scale (RSES)One dayThe RSES (Rosenberg, 1965) assesses global self-esteem.
Question of Belonging (QoB)One weekThe QoB (Walton & Cohen, 2007) assesses the extent to which students feel like they belong within their university community.

Other

MeasureTime frameDescription
Simulator Sickness Questionnaire (SSQ)One monthThe SSQ (Kennedy et al., 1993) measures the presence of potential negative effects associated with using VR.
IAPT Patient Experience Questionnaire (IAPT-PEQ)One monthTo assess how participants experienced the intervention, we will adapt the PEQ used in IAPT services (Clarke, 2011).
Edinburgh adverse effects of psychological therapy (EDAPT)One monthThe EDAPT (Mc Glanaghy et al., 2021) was developed via a Delphi consultation with experts by experience and profession. The EDAPT is a checklist of 42 items each reflecting a potential adverse event that could occur after receiving a psychological therapy.
Friends and family test (FFT)One monthThe FFT (Department of Health, 2013) is used across all NHS services as a measure of patient satisfaction.

Countries

United Kingdom

Contacts

Primary ContactCassie M Hazell, PhD
cassie.hazell@surrey.ac.uk01483 300800
Backup ContactJoanna Birkett, DClin
j.birkett@westminster.ac.uk020 7911 5000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026