UniVRse: VR-CBT for Students With Social Anxiety (UniVRse)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Social Anxiety
• Intervention / Treatment: Behavioral: UniVRse + TAU

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassie M Hazell, PhD; Phone Number: 01483 300800; Email: cassie.hazell@surrey.ac.uk
• Study Contact Backup: Name: Joanna Birkett, DClin; Phone Number: 69066 020 7911 5000; Email: j.birkett@westminster.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • University of Westminster
    • Contact: Cassie Hazell; Email: cassie.hazell@surrey.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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/exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist + TAU; We will be using a wait list control group. The wait list control group will receive treatment as usual for the duration of the trial. Treatment as usual may include active monitoring, meetings with academic advisors, psychiatric medication, and/or support from an NHS mental health team. We will not withhold treatment from the control group, but prospective participants may not be eligible to take part if they have current or confirmed plans to receive a psychology therapy (see exclusion criteria). Once the trial has ended, the participants in the control arm will be the first to be offered UniVRse when it is taken up by university support services.
Experimental: UniVRse + TAU; UniVRse is a Virtual Reality (VR) intervention targeting social anxiety in students using cognitive behavioural therapy (CBT) techniques - specifically graded exposure. Participants will have access to UniVRse for a month post-randomisation and it is recommended they complete 6 sessions each 30-minutes long over this period. Exposure to the intervention will be reached if participants complete 2 30-minute sessions. UniVRse is a self-help intervention meaning that participants can engage in the intervention independently. Participants will be supported to progress through the UniVRse programme by a virtual mentor called Sam that will take on the role traditionally undertaken by the 'therapist'. Sam's function will be to provide psychoeducation, provide instruction on how to use the VR kit and interact with the virtual environment, and provide support and encouragement. Participants will be able to complete the intervention either on campus or at home.	Behavioral: UniVRse + 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: Attending a lecture;; Group work in a seminar;; Delivering a presentation;; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Phobia Inventory (SPIN)	The Social Phobia Inventory (SPIN) (Connor et al., 2000) is a 17-item questionnaire measuring social anxiety.	One week
Modified Liebowitz Social Anxiety Scale (MLSAS-SR)	We 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.	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire 9 (PHQ-9)	The PHQ-9 (Spitzer et al., 1999) measures levels of depression.	Last 2 weeks
Generalised Anxiety Disorder 7 (GAD-7)	Developed 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.	Last 2 weeks
The Rathus Assertiveness Schedule (RAS)	The RAS (Rathus, 1973) was developed to measure general assertiveness.	One day
Spreitzer's Psychological Empowerment Scale (SPES)	The SPES (Spreitzer, 1995) assesses assertiveness in a specific context in terms of feeling empowered.	One week
Short Instrument for measuring students' Confidence with Key Skills (SICKS)	The SICKS (Bray et al., 2020) assesses students' confidence in relation to a range of education-related activities.	One week
Rosenberg self-esteem scale (RSES)	The RSES (Rosenberg, 1965) assesses global self-esteem.	One day
Question of Belonging (QoB)	The QoB (Walton & Cohen, 2007) assesses the extent to which students feel like they belong within their university community.	One week
Identification with University (IwU)	The 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.	One week
Domain Specific Hope Scale - Social Hope (DSHS-SH) and Academic Hope (DSHS-AH) subscales	The 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).	One day
Attendance	The 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.	Two weeks
Cortisol in saliva samples	We 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.	Three days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh adverse effects of psychological therapy (EDAPT)	The 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.	One month
IAPT Patient Experience Questionnaire (IAPT-PEQ)	To assess how participants experienced the intervention, we will adapt the PEQ used in IAPT services (Clarke, 2011).	One month
Friends and family test (FFT)	The FFT (Department of Health, 2013) is used across all NHS services as a measure of patient satisfaction.	One month
Simulator Sickness Questionnaire (SSQ)	The SSQ (Kennedy et al., 1993) measures the presence of potential negative effects associated with using VR.	One month

Collaborators and Investigators

• Sponsor: University of Surrey
• Collaborators: University of Nottingham; University of Sussex; University of Westminster

Publications and helpful links

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Students; Cognitive Behaviour Therapy; Social anxiety; University
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ETH2122-3503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No