跳至主要内容
临床试验/NCT05157477
NCT05157477招募中不适用

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 人开始时间: 2020年6月17日最近更新:
适应症
干预措施

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
The change of heart rate

研究概览

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.

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 (Participant)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

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

Control group

No Intervention

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.

VR-Group

Experimental

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 (Behavioral)

CBT-GROUP

Experimental

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 (Behavioral)

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Targeting the Sensory Disturbance in Autism Spectrum... | 临床试验