UniVRse: VR-CBT for Students With Social Anxiety

NCT ID: NCT05704868

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2024-07-01

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.

Conditions

Social Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

UniVRse + TAU

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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:

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Westminster

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: collaborator

University of Sussex

OTHER

Sponsor Role: collaborator

University of Surrey

OTHER

Sponsor Role: lead

Responsible Party

Cassie Hazell

Lecturer B

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Westminster

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Cassie M Hazell, PhD

Role: CONTACT

cassie.hazell@surrey.ac.uk

01483 300800

Joanna Birkett, DClin

Role: CONTACT

j.birkett@westminster.ac.uk

020 7911 5000 ext. 69066

Facility Contacts

Cassie Hazell

Role: primary

cassie.hazell@surrey.ac.uk

Related Links

http://blog.westminster.ac.uk/univrse/

Project website

Other Identifiers

ETH2122-3503

Identifier Type: -

Identifier Source: org_study_id