ClinicalTrials.gg
RecruitingNCT05157477Updated Jul 31, 2026

Targeting the Sensory Disturbance in Autism Spectrum Disorder

An interventional study of CBT-based VR exporsure program in Autistic Disorders Spectrum, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jun 2020, registered Dec 2021).
  • Started Jun 2020; still recruiting 6 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
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Study 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.

02

Conditions studied

  • Autistic Disorders Spectrum

Keywords

  • autism spectrum; sensory disturbance; intervention; virtual reality; cognitive behavior therapy
03

In context

Child Development Disorders, Pervasive

117 studies on the registry are indexed under Child Development Disorders, Pervasive; 15 are open to participants now.

This study's planned enrollment of 90 is above the median of 45 across 85 interventional studies indexed under Child Development Disorders, Pervasive.

Browse Child Development Disorders, Pervasive studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ;
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • 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.

    Behavioral: CBT-based VR exporsure program

  • Experimental
    CBT-GROUP

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

    Behavioral: CBT-based VR exporsure program

  • 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.

Interventions

  • BehavioralCBT-based VR exporsure program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Two months, first time in the first week and second time in the last week.

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2020 (actual). Primary completion is estimated for Dec 2027, 90 months after the start.

Of 29 non-industry interventional studies with no phase under Child Development Disorders, Pervasive, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 64. This study's planned 90 months is above that.

Counting every sponsor, half of 30 studies reached it within 26 months; a quarter within 9 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2021
First posted
Dec 15, 2021
StartActual
Jun 17, 2020
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05157477
Responsible party
Sponsor
First posted
Dec 15, 2021
Start date
Jun 17, 2020
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 31, 2026

Study contacts

Yi-Ling Chien, Ph.D
Contact
chienyiling@gmail.com
+886-2-23123456 ext. 66013

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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