Clinical trial NCT05704868: UniVRse: VR-CBT for Students With Social Anxiety
Official title: UniVRse: Pilot Randomised Controlled Trial of Virtual Reality Cognitive Behaviour Therapy (VR-CBT) for Students With Social Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety
Keywords: Social anxiety
Students
University
Virtual Reality
Cognitive Behaviour Therapy
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: University of Westminster
name: University of Nottingham
name: University of Sussex
First posted: 2023-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;
* 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.

Primary outcomes:
measure: Social Phobia Inventory (SPIN)
timeFrame: One week
measure: Modified Liebowitz Social Anxiety Scale (MLSAS-SR)
timeFrame: One week
Secondary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Last 2 weeks
measure: Generalised Anxiety Disorder 7 (GAD-7)
timeFrame: Last 2 weeks
measure: The Rathus Assertiveness Schedule (RAS)
timeFrame: One day
measure: Spreitzer's Psychological Empowerment Scale (SPES)
timeFrame: One week
measure: Short Instrument for measuring students' Confidence with Key Skills (SICKS)
timeFrame: One week
measure: Rosenberg self-esteem scale (RSES)
timeFrame: One day
measure: Question of Belonging (QoB)
timeFrame: One week
measure: Identification with University (IwU)
timeFrame: One week
measure: Domain Specific Hope Scale - Social Hope (DSHS-SH) and Academic Hope (DSHS-AH) subscales
timeFrame: One day
measure: Attendance
timeFrame: Two weeks
measure: Cortisol in saliva samples
timeFrame: Three days
Other outcomes:
measure: Edinburgh adverse effects of psychological therapy (EDAPT)
timeFrame: One month
measure: IAPT Patient Experience Questionnaire (IAPT-PEQ)
timeFrame: One month
measure: Friends and family test (FFT)
timeFrame: One month
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: One month
Locations:
city: London
country: United Kingdom
facility: University of Westminster
Study officials:
References: