Back to resultsTargeting the Sensory Disturbance in Autism Spectrum Disorder
Primary Purpose
Autistic Disorders Spectrum
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CBT-based VR exporsure program
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorders Spectrum focused on measuring autism spectrum; sensory disturbance; intervention; virtual reality; cognitive behavior therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
VR-Group
CBT-GROUP
Control group
Arm Description
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.
The 'CBT alone' intervention applies the same protocol excluding VR exposure, which is replaced by traditional role play with the therapist.
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.
Outcomes
Primary Outcome Measures
The change of heart rate
The change of heart rate is related to the activation level of sympathetic nervous system, which can describe the change on anxiety level.
Secondary Outcome Measures
Full Information
NCT ID
NCT05157477
First Posted
December 2, 2021
Last Updated
April 12, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05157477
Brief Title
Targeting the Sensory Disturbance in Autism Spectrum Disorder
Official Title
Targeting the Sensory Disturbance in Autism Spectrum Disorder: The Effectiveness of Cognitive-behavior Therapy-based Virtual Reality Exposure Program
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorders Spectrum
Keywords
autism spectrum; sensory disturbance; intervention; virtual reality; cognitive behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VR-Group
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT-GROUP
Arm Type
Experimental
Arm Description
The 'CBT alone' intervention applies the same protocol excluding VR exposure, which is replaced by traditional role play with the therapist.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT-based VR exporsure program
Intervention Description
This project seeks to establish a 8-week CBT-based VR exposure program to tackle sensory problems in ASD according to the theory of exposure and desensitization (both social and non-social scenarios) as well as identifying dysfunctional thought and searching for alternative thinking. In brief, this program aims to build up the core competence of the ASD individuals in facing the sensory environment, including (1) Relaxation skills (2) Ranking the fearful sensory situations (3) Anxiety coping strategy (3) Graded exposure (4) Cognitive appraisal and restructuring: identifying the dysfunctional thought when facing the social situations and figuring out alternative thinking.
Primary Outcome Measure Information:
Title
The change of heart rate
Description
The change of heart rate is related to the activation level of sympathetic nervous system, which can describe the change on anxiety level.
Time Frame
Two months, first time in the first week and second time in the last week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ling Chien, Ph.D
Phone
+886-2-23123456
Ext
66013
Email
chienyiling@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Targeting the Sensory Disturbance in Autism Spectrum Disorder
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