UniVRse: Pilot Randomised Controlled Trial of Virtual Reality Cognitive Behaviour Therapy (VR-CBT) for Students With Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Social Phobia Inventory (SPIN)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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-
- •These participants may still participate in the wider UniVRse trial if they meet all of the aforementioned main trial inclusion/exclusion criteria.
结局指标
主要结局
Social Phobia Inventory (SPIN)
时间窗: 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)
时间窗: 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.
次要结局
- Rosenberg self-esteem scale (RSES)(One day)
- Cortisol in saliva samples(Three days)
- Patient Health Questionnaire 9 (PHQ-9)(Last 2 weeks)
- Attendance(Two weeks)
- Generalised Anxiety Disorder 7 (GAD-7)(Last 2 weeks)
- Spreitzer's Psychological Empowerment Scale (SPES)(One week)
- Short Instrument for measuring students' Confidence with Key Skills (SICKS)(One week)
- Domain Specific Hope Scale - Social Hope (DSHS-SH) and Academic Hope (DSHS-AH) subscales(One day)
- The Rathus Assertiveness Schedule (RAS)(One day)
- Question of Belonging (QoB)(One week)
- Identification with University (IwU)(One week)
研究者
Cassie Hazell
Lecturer B
University of Surrey