UniVRse: VR-CBT for Students With Social Anxiety

University of Surrey

Status: Enrolling

Conditions: Social Anxiety

Treatments: Behavioral: UniVRse + TAU

Study type: Interventional

Funder types: Other

Identifiers

NCT05704868

ETH2122-3503

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

UniVRse + TAU

Experimental group

Description:

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.

Treatment:

Behavioral: UniVRse + TAU

Waitlist + TAU

No Intervention group

Description:

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.