UniVRse: VR-CBT for Students With Social Anxiety

NCT05704868 | Recruiting

• 1 other identifier: ETH2122-3503
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 1.To determine whether a full trial is justified;
2. 2.To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial;
3. 3.To address questions concerning study recruitment, retention, and acceptability.

Conditions

Social Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Patient Health Questionnaire 9 (PHQ-9)

  Last 2 weeks

• Generalised Anxiety Disorder 7 (GAD-7)

  Last 2 weeks

• The Rathus Assertiveness Schedule (RAS)

  One day

• Spreitzer's Psychological Empowerment Scale (SPES)

  One week

• Short Instrument for measuring students' Confidence with Key Skills (SICKS)

  One week

Other Outcomes (4)

• Edinburgh adverse effects of psychological therapy (EDAPT)

  One month

• IAPT Patient Experience Questionnaire (IAPT-PEQ)

  One month

• Friends and family test (FFT)

  One month

Study Arms (2)

UniVRse + TAU

EXPERIMENTAL

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

Waitlist + TAU

NO INTERVENTION

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.

Interventions

UniVRse + TAU 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.

UniVRse + TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Surrey: lead
• University of Westminster: collaborator
• University of Nottingham: collaborator
• University of Sussex: collaborator

Study Sites (1)

University of Westminster

London, United Kingdom

RECRUITING

Related Links

• Project website

Central Study Contacts

Cassie M Hazell, PhD

CONTACT

01483 300800; cassie.hazell@surrey.ac.uk

Joanna Birkett, DClin

CONTACT

020 7911 5000; j.birkett@westminster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer B

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 30, 2023
• Study Start: December 8, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

GB (1)