Social AnxietyUniVRseNCT05704868
UniVRse: VR-CBT for Students With Social Anxiety
A study testing UniVRse + TAU in people with Social Anxiety, run by University of Surrey at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety
- What is being tested?
- UniVRse + TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Westminster
London
Cassie Hazell, cassie.hazell@surrey.ac.uk
About this study
Official title: UniVRse: Pilot Randomised Controlled Trial of Virtual Reality Cognitive Behaviour Therapy (VR-CBT) for Students With Social Anxiety
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:
- To determine whether a full trial is justified;
- To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial;
- 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
- Being tested
- UniVRse + TAU
- Keywords
- Social anxiety, Students, University, Virtual Reality, Cognitive Behaviour Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UniVRse + TAUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Phobia Inventory (SPIN)
The Social Phobia Inventory (SPIN) (Connor et al., 2000) is a 17-item questionnaire measuring social anxiety.
Measured: 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.
Measured: One week
Secondary outcomes (11)
Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 (Spitzer et al., 1999) measures levels of depression.
Measured: Last 2 weeks
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.
Measured: Last 2 weeks
The Rathus Assertiveness Schedule (RAS)
The RAS (Rathus, 1973) was developed to measure general assertiveness.
Measured: One day
Spreitzer's Psychological Empowerment Scale (SPES)
The SPES (Spreitzer, 1995) assesses assertiveness in a specific context in terms of feeling empowered.
Measured: One week
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.
Measured: One week
Rosenberg self-esteem scale (RSES)
The RSES (Rosenberg, 1965) assesses global self-esteem.
Measured: One day
Question of Belonging (QoB)
The QoB (Walton \& Cohen, 2007) assesses the extent to which students feel like they belong within their university community.
Measured: One week
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.
Measured: One week
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).
Measured: One day
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.
Measured: Two weeks
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.
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start8 Dec 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Westminster, University of Nottingham, University of Sussex
- Responsible party
- Principal investigator, Cassie Hazell, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704868
- Sponsor's protocol ID
- ETH2122-3503
- Acronym
- UniVRse
- Status last verified
- May 2024
- First submitted
- 12 Dec 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hazell CM, Malinowski J, Edwards B, Bergin ADG, Berry C, Flynn M, Smyth N, Birkett J. UniVRse: protocol for a pilot randomised controlled trial of virtual reality cognitive-behaviour therapy for students with social anxiety. Pilot Feasibility Stud. 2026 Feb 5;12(1):25. doi: 10.1186/s40814-026-01771-4.
PubMed 41645300
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UniVRse: Pilot Randomised Controlled Trial of Virtual Reality Cognitive Behaviour Therapy (VR-CBT) for Students With Social Anxiety
- ClinicalTrials.gov ID
- NCT05704868
- Acronym / sponsor ID
- UniVRse / ETH2122-3503
- Conditions
- Social Anxiety
- Keywords
- Social anxiety, Students, University, Virtual Reality, Cognitive Behaviour Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- University of Westminster, University of Nottingham, University of Sussex
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine whether a full trial is justified;
- To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UniVRse + TAU | Experimental | Behavioral: UniVRse + TAUUniVRse 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UniVRse + TAUUniVRse 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. | Behavioural | UniVRse + TAU |
Primary outcome
Social Phobia Inventory (SPIN)
Time frame: One week
The Social Phobia Inventory (SPIN) (Connor et al., 2000) is a 17-item questionnaire measuring social anxiety.
Modified Liebowitz Social Anxiety Scale (MLSAS-SR)
Time frame: One week
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.
11 secondary outcomes
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Last 2 weeks
Generalised Anxiety Disorder 7 (GAD-7)
Time frame: Last 2 weeks
The Rathus Assertiveness Schedule (RAS)
Time frame: One day
Spreitzer's Psychological Empowerment Scale (SPES)
Time frame: One week
Short Instrument for measuring students' Confidence with Key Skills (SICKS)
Time frame: One week
Rosenberg self-esteem scale (RSES)
Time frame: One day
Question of Belonging (QoB)
Time frame: One week
Identification with University (IwU)
Time frame: One week
Domain Specific Hope Scale - Social Hope (DSHS-SH) and Academic Hope (DSHS-AH) subscales
Time frame: One day
Attendance
Time frame: Two weeks
Cortisol in saliva samples
Time frame: Three days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 41645300Hazell CM, Malinowski J, Edwards B, Bergin ADG, Berry C, Flynn M, Smyth N, Birkett J. UniVRse: protocol for a pilot randomised controlled trial of virtual reality cognitive-behaviour therapy for students with social anxiety. Pilot Feasibility Stud. 2026 Feb 5;12(1):25. doi: 10.1186/s40814-026-01771-4.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UniVRse + TAU in people with Social Anxiety, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cassie M Hazell, PhD (01483 300800, cassie.hazell@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Phobia Inventory (SPIN) (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.