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临床试验/NCT04301141
NCT04301141Unknown不适用

Using Virtual Reality Assisted Therapy for Social Anxiety in Adolescents With Autism Spectrum Disorder: A Case Series

King's College London6 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
5
试验地点
6
主要终点
VR session completion rate.

研究概览

简要总结

This study will test the feasibility and acceptability of virtual reality assisted cognitive behavioural therapy for the treatment of social anxiety in autistic adolescents. Five adolescents will receive the intervention and a parent/caregiver of each adolescent will be asked to act as informants on some questionnaires and interviews.

详细描述

Difficulties interacting with others in social situations is a core characteristic of autism spectrum disorder (ASD). These difficulties are intensified by social anxiety - commonly experienced in autistic adolescents. A promising psychological treatment is cognitive behavioural therapy (CBT), but there are constraints in its use for the autistic population. For example, CBT requires patients to imagine being in a social situation that would cause anxiety, but autistic people often experience difficulties with imagination. The use of virtual reality (VR) in CBT may help to lessen such constraints. VR uses 3D computer-generated visual environments displayed through a head-mounted display. The images are synchronised to the movements of the user such that they experience feeling immersed in the virtual scene. The virtual scene can involve social scenarios, making it an ideal tool for eliciting social anxiety in the treatment setting. The investigators can see if these virtual scenarios are indeed eliciting social anxiety by recording physiological responses (e.g. heart rate) in parallel with patients' anxiety ratings during exposure. This is important for CBT to be effective.

This study will test the feasibility and acceptability of VR-assisted CBT, combined with the use of physiological measurements, in autistic adolescents experiencing social anxiety. The therapy will typically consist of 8-20 weekly sessions and will be delivered by clinical psychologists in local mental health services. Conventional outcome measures will be used and feedback from youth and their parents/caregivers will be requested. The results of this study may lead to modification of the treatment and research methods. They will inform a later pilot randomised controlled trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be included at screening if:
  • Aged between 13 and 18 years
  • Clinically diagnosed with ASD by a neurodevelopmental clinician
  • Experiencing anxiety in social situations that is impairing daily functioning as determined by clinicians
  • Deemed suitable by the clinical team for the intervention based on factors such as sufficient verbal ability, desire to participate, willingness to undertake exposure-based activities, and no current/active suicidal plans.
  • Able to speak and understand English fluently
  • Patient and parents/caregivers agree to CBT

排除标准

  • Participants will be excluded at screening if:
  • Diagnosed with photosensitive epilepsy
  • Receiving concurrent psychological therapy
  • Immediate plans are in-place to change their psychopharmacological medication regimen

结局指标

主要结局

VR session completion rate.

时间窗: Through study completion, anticipated duration of 9 months.

This will be indicated by the proportion of the patients who commenced the VR component that completed it. Completion is defined as 75% attendance of the total VR exposure sessions recommended by the therapist. Not all therapy sessions involve VR exposure.

次要结局

  • Rate of participant identification.(End of recruitment period, maximum duration 7.5 months from study start date.)
  • Recruitment rate.(Through study completion, anticipated duration of 9 months.)
  • Rate of participant retention.(Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.)
  • Therapy attendance.(End of therapy up to 20 weeks.)
  • Frequency and number of sessions.(Through study completion, anticipated duration of 9 months.)
  • Adverse effects.(During and immediately after the intervention.)
  • Experience and opinions on the intervention.(End of therapy up to 20 weeks.)
  • Data completion rates.(End of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.)
  • Homework compliance.(End of therapy up to 20 weeks.)
  • Change in progress with attaining therapy goals.(Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.)
  • Change in anxiety (including social anxiety) and depression levels.(Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.)
  • Change in Global Outcome Ratings of Severity of Illness.(Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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