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临床试验/NCT05157477
NCT05157477
已完成
不适用

Targeting the Sensory Disturbance in Autism Spectrum Disorder: The Effectiveness of Cognitive-behavior Therapy-based Virtual Reality Exposure Program

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 90 人2020年6月17日

概览

阶段
不适用
干预措施
CBT-based VR exporsure program
疾病 / 适应症
Autistic Disorders Spectrum
发起方
National Taiwan University Hospital
入组人数
90
试验地点
1
主要终点
The change of heart rate
状态
已完成
最后更新
2个月前

概览

简要总结

This study aims to establish a cognitive-behavior therapy (CBT) based virtual exposure (VR) exposure program to train ASD adults coping with everyday sensory scenarios. Through the practice and training, the ASD participants may learn the strategy to deal with the common sensory scenarios and master the anxiety around the exposure. The anticipatory anxiety and the maladaptive behaviors may be decreased along with the process of desensitization, while the functional impairment related to sensory sensitivity can partly be recovered.

注册库
clinicaltrials.gov
开始日期
2020年6月17日
结束日期
2023年12月31日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • young adult aged between 18 and 45 years who had a diagnosis of ASD from a licensed mental health or medical professional based on DSM-5;
  • has sensory and social problems as reported by the participant and the caregiver;
  • is motivated to participate in the treatment;
  • is fluent in Chinese;
  • has a full-scale IQ \> 70 on WAIS-IV;
  • scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.

排除标准

  • A history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases;
  • visual impairment and/or hearing impairment that would preclude participation in the CBT-based VR exposure program

研究组 & 干预措施

VR-Group

The participants who are randomized into 'CBT-based VR exposure program' (CBT+VR group) will receive the individual intervention weekly with a total of 8 sessions. The therapists, PI (Chien YL) and a clinical psychologist who is familiar with ASD psychopathology and CBT approach, will provide the CBT-based VR exposure intervention for each individual every week based on the above protocol. The participants complete the homework (i.e., relaxation and real-life exposure) between the sessions, and record 'anxiety level' before, during, and after the real-life exposure. The outcome measures will be scheduled at the end of intervention (8th week) within one week of program closure.

干预措施: CBT-based VR exporsure program

CBT-GROUP

The 'CBT alone' intervention applies the same protocol excluding VR exposure, which is replaced by traditional role play with the therapist.

干预措施: CBT-based VR exporsure program

Control group

The participants who are randomized into control group will be regularly followed in a naturalistic outpatient clinic setting (every 2-4 week). During the clinic, sensory and socioemotional problems will be discussed face-to-face for 10 to 20 minutes, some self-help books will be recommended.

结局指标

主要结局

The change of heart rate

时间窗: Two months, first time in the first week and second time in the last week.

The change of heart rate is related to the activation level of sympathetic nervous system, which can describe the change on anxiety level.

研究点 (1)

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