Back to resultsUniVRse: VR-CBT for Students With Social Anxiety (UniVRse)
Primary Purpose
Social Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UniVRse + TAU
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety focused on measuring Social anxiety, Students, University, Virtual Reality, Cognitive Behaviour Therapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
UniVRse + TAU
Waitlist + TAU
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Social Phobia Inventory (SPIN)
The Social Phobia Inventory (SPIN) (Connor et al., 2000) is a 17-item questionnaire measuring social anxiety.
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.
Secondary Outcome Measures
Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 (Spitzer et al., 1999) measures levels of depression.
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.
The Rathus Assertiveness Schedule (RAS)
The RAS (Rathus, 1973) was developed to measure general assertiveness.
Spreitzer's Psychological Empowerment Scale (SPES)
The SPES (Spreitzer, 1995) assesses assertiveness in a specific context in terms of feeling empowered.
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.
Rosenberg self-esteem scale (RSES)
The RSES (Rosenberg, 1965) assesses global self-esteem.
Question of Belonging (QoB)
The QoB (Walton & Cohen, 2007) assesses the extent to which students feel like they belong within their university community.
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.
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).
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.
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.
Full Information
NCT ID
NCT05704868
First Posted
December 12, 2022
Last Updated
October 18, 2023
Sponsor
University of Surrey
Collaborators
University of Westminster, University of Nottingham, University of Sussex
1. Study Identification
Unique Protocol Identification Number
NCT05704868
Brief Title
UniVRse: VR-CBT for Students With Social Anxiety
Acronym
UniVRse
Official Title
UniVRse: Pilot Randomised Controlled Trial of Virtual Reality Cognitive Behaviour Therapy (VR-CBT) for Students With Social Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Surrey
Collaborators
University of Westminster, University of Nottingham, University of Sussex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
Keywords
Social anxiety, Students, University, Virtual Reality, Cognitive Behaviour Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UniVRse + TAU
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist + TAU
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
UniVRse + TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Phobia Inventory (SPIN)
Description
The Social Phobia Inventory (SPIN) (Connor et al., 2000) is a 17-item questionnaire measuring social anxiety.
Time Frame
One week
Title
Modified Liebowitz Social Anxiety Scale (MLSAS-SR)
Description
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.
Time Frame
One week
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
The PHQ-9 (Spitzer et al., 1999) measures levels of depression.
Time Frame
Last 2 weeks
Title
Generalised Anxiety Disorder 7 (GAD-7)
Description
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.
Time Frame
Last 2 weeks
Title
The Rathus Assertiveness Schedule (RAS)
Description
The RAS (Rathus, 1973) was developed to measure general assertiveness.
Time Frame
One day
Title
Spreitzer's Psychological Empowerment Scale (SPES)
Description
The SPES (Spreitzer, 1995) assesses assertiveness in a specific context in terms of feeling empowered.
Time Frame
One week
Title
Short Instrument for measuring students' Confidence with Key Skills (SICKS)
Description
The SICKS (Bray et al., 2020) assesses students' confidence in relation to a range of education-related activities.
Time Frame
One week
Title
Rosenberg self-esteem scale (RSES)
Description
The RSES (Rosenberg, 1965) assesses global self-esteem.
Time Frame
One day
Title
Question of Belonging (QoB)
Description
The QoB (Walton & Cohen, 2007) assesses the extent to which students feel like they belong within their university community.
Time Frame
One week
Title
Identification with University (IwU)
Description
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.
Time Frame
One week
Title
Domain Specific Hope Scale - Social Hope (DSHS-SH) and Academic Hope (DSHS-AH) subscales
Description
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).
Time Frame
One day
Title
Attendance
Description
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.
Time Frame
Two weeks
Title
Cortisol in saliva samples
Description
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.
Time Frame
Three days
Other Pre-specified Outcome Measures:
Title
Edinburgh adverse effects of psychological therapy (EDAPT)
Description
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.
Time Frame
One month
Title
IAPT Patient Experience Questionnaire (IAPT-PEQ)
Description
To assess how participants experienced the intervention, we will adapt the PEQ used in IAPT services (Clarke, 2011).
Time Frame
One month
Title
Friends and family test (FFT)
Description
The FFT (Department of Health, 2013) is used across all NHS services as a measure of patient satisfaction.
Time Frame
One month
Title
Simulator Sickness Questionnaire (SSQ)
Description
The SSQ (Kennedy et al., 1993) measures the presence of potential negative effects associated with using VR.
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassie M Hazell, PhD
Phone
01483 300800
Email
cassie.hazell@surrey.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Birkett, DClin
Phone
020 7911 5000
Ext
69066
Email
j.birkett@westminster.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://blog.westminster.ac.uk/univrse/
Description
Project website
Learn more about this trial
UniVRse: VR-CBT for Students With Social Anxiety
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