UniVRse: VR-CBT for Students With Social Anxiety

Social Anxiety Clinical Trial

— UniVRse  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704868
• Other study ID #: ETH2122-3503
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: University of Surrey
• Contact: Cassie M Hazell, PhD
• Phone: 01483 300800
• Email: cassie.hazell[@]surrey.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Westminster	London

Sponsors (4)

Lead Sponsor	Collaborator
University of Surrey	University of Nottingham, University of Sussex, University of Westminster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Simulator Sickness Questionnaire (SSQ)	The SSQ (Kennedy et al., 1993) measures the presence of potential negative effects associated with using VR.	One month
Primary	Social Phobia Inventory (SPIN)	The Social Phobia Inventory (SPIN) (Connor et al., 2000) is a 17-item questionnaire measuring social anxiety.	One week
Primary	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	Patient Health Questionnaire 9 (PHQ-9)	The PHQ-9 (Spitzer et al., 1999) measures levels of depression.	Last 2 weeks
Secondary	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
Secondary	The Rathus Assertiveness Schedule (RAS)	The RAS (Rathus, 1973) was developed to measure general assertiveness.	One day
Secondary	Spreitzer's Psychological Empowerment Scale (SPES)	The SPES (Spreitzer, 1995) assesses assertiveness in a specific context in terms of feeling empowered.	One week
Secondary	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
Secondary	Rosenberg self-esteem scale (RSES)	The RSES (Rosenberg, 1965) assesses global self-esteem.	One day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Project website