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Active, not recruitingNCT05886361Updated Aug 17, 2026

Somatic Symptoms in Autism Spectrum Disorder: Data Integration

An observational study in Autism Spectrum Disorder and Somatic Symptom Disorder, sponsored by National Taiwan University Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 15 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
600
Ages
15 Years to 70 Years
Sex
All
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Study summary

Autistic patients have higher rates of co-morbid somatic symptoms. Thus, compared to the general population, they experience more health-related concerns, such as autoimmune disease, gastrointestinal disease, cardiovascular disease, and autonomic disorders. On average, an autistic patient's life span is 16 years shorter than that of a non-autistic patient. Furthermore, autistic patients are often unable to convey or communicate their somatic symptoms in a clear and comprehensive manner. This leads to a lack of proper health care provided in a timely manner.

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Conditions studied

  • Autism Spectrum Disorder
  • Somatic Symptom Disorder

Keywords

  • Autism spectrum disorder
  • Somatic symptoms
  • Sensory sensitivity
  • Anxiety
  • Depression
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In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's planned enrollment of 600 is above the median of 102 across 320 observational studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder 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.

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Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This is a retrospective study of existing data. Data from several hundred individuals was previously collected in other studies. These existing data are separated into three groups, as mentioned in the eligibility criteria

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

  • ASD group: diagnosed with autism spectrum disorder
  • clinical group: anxiety, depression, somatic disorder who are non-psychotic and non-organic
  • control group: healthy control without psychiatric disorder or chronic somatic symptoms
  • age between 15 and 70

Exclusion criteria

Exclusion Criteria:

  • psychiatric disorders such as schizophrenia, mood disorder.
  • major physical disorder which can be potentially lethal
  • who cannot read or comprehend the survey and questionnaire
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.

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • ASD

    Diagnosed with DSM-5 autism spectrum disorder

    Other: No intervention involved

  • Clinical

    Patients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic

    Other: No intervention involved

  • Control

    Healthy control without psychiatric disorder or chronic somatic symptoms

    Other: No intervention involved

Interventions

  • OtherNo intervention involved

    No intervention involved

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What researchers measure

Primary outcomes

  1. Patient health questionnaire-15, PHQ-15

    range from 0 to 2 for each item, total score range from 0 to 30. Higher the score, worse the level of somatization

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  2. Health assessment questionnaire, HAQ

    range from 0 to 3 for each item. Higher the score, worse the disability

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  3. Beck depression inventory, BDI

    range from 0 to 3 for each item. Higher the score, worse the depression

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  4. Beck anxiety inventory

    range from 0 to 3 for each item. Total score 0 to 63. Higher the score, worse the anxiety

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  5. Tridimensional Personality Questionnaire (TPQ)

    a 100-item, true/false psychological test, measures three neurotransmitter-linked personality dimensions: 1. novelty seeking. High scores indicate individuals who are adventurous, easily bored, impulsive, and quick to react to new stimuli. Low Scores indicate individuals who are reflective, rigid, orderly, systematic, and comfortable with routine. 2. harm avoidance. High Scores: Indicates individuals who are cautious, fearful, socially inhibited, and prone to worry or depression.Low Scores: Indicates individuals who are confident, carefree, optimistic, relaxed, and resilient to stress. 3. reward dependence. High Scores: Indicates individuals who are warm, empathetic, socially sensitive, and highly motivated by praise.Low Scores: Indicates individuals who are independent, practical, socially detached, and emotionally self-sufficient.

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  6. WHO Quality of Life-BREF (WHOQOL-BREF)

    a 26-item survey by the World Health Organization that measures personal well-being across four core domains: physical health, psychological health, social relationships, and environment. Scores are scaled from 0 to 100, where higher numbers show a better quality of life.

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  7. Sensory profile

    a standardized questionnaire completed by caregivers, teachers, or individuals to evaluate how a person processes everyday sensory information (like touch, sound, and movement). It measures how a person's nervous system responds to sensory inputs and how those responses affect daily life. Results describe an individual in the following four areas: Seeking: Actively searches for extra sensory input (e.g., loves spinning, crashing into things, chewing objects, or loud music). Sensitivity: Detects sensory input very quickly and easily, noticing small details (e.g., easily distracted by background noise or bright lights). Avoiding: Actively tries to escape or prevent sensory input (e.g., covers ears in loud rooms, refuses certain clothing textures, or avoids crowds). Low Registration: Misses or is slow to notice sensory input (e.g., doesn't respond to their name, seems clumsy, or doesn't notice pain/temperatures).

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  8. Social responsiveness scale (SRS)

    a 65-item questionnaire that measures the severity of social impairment and autism spectrum-related traits. It evaluates how a person acts in real-life social settings. Higher scores represent greater impairment.

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  9. Autism Spectrum Quotient (AQ)

    The Autism Spectrum Quotient (AQ) is a 50-item self-report questionnaire used to measure autistic traits in adults and teens. Scores range from 0 to 50. A score of 26 or higher suggests elevated autistic traits, while 32 or higher indicates a strong presence of these traits.

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

  10. Empathy Quotient (EQ)

    The Empathy Quotient (EQ) is a self-report questionnaire developed by psychologist Simon Baron-Cohen to measure a person's ability to understand others' thoughts and feel appropriate emotional responses. The standard test has 60 items (40 scored statements and 20 filler questions) spanning cognitive empathy, emotional reactivity, and social skills. Higher scores indicate higher empathy levels.

    Time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 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
NCT05886361
Responsible party
Sponsor
First posted
Jun 2, 2023
Start date
Jul 1, 2022
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 17, 2026

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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