- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05157477
Targeting the Sensory Disturbance in Autism Spectrum Disorder
March 2, 2026 updated by: National Taiwan University Hospital
Targeting the Sensory Disturbance in Autism Spectrum Disorder: The Effectiveness of Cognitive-behavior Therapy-based Virtual Reality Exposure Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan
- National Taiwan University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
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Experimental: CBT-GROUP
The 'CBT alone' intervention applies the same protocol excluding VR exposure, which is replaced by traditional role play with the therapist.
|
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.
|
|
No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of heart rate
Time Frame: 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.
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Two months, first time in the first week and second time in the last week.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 17, 2020
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
December 2, 2021
First Submitted That Met QC Criteria
December 2, 2021
First Posted (Actual)
December 15, 2021
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201712172RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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