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Active, not recruiting

NCT Number: NCT05886361

Somatic Symptoms in Autism Spectrum Disorder: Data Integration

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASD group: diagnosed with DSM-5 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

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

Treatment and study plan

No intervention involved

Other

No intervention involved

Primary outcomes

  1. Patient health questionnaire-15, PHQ-15

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

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

  2. Health assessment questionnaire, HAQ

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

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

  3. Beck depression inventory, BDI

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

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

  4. Beck anxiety inventory

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

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

  5. Tridimensional Personality Questionnaire (TPQ)

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

    a 100-item, true/false psychological test, measures three neurotransmitter-linked personality dimensions:

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

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

    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.

  7. Sensory profile

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

    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).

  8. Social responsiveness scale (SRS)

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

    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.

  9. Autism Spectrum Quotient (AQ)

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

    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.

  10. Empathy Quotient (EQ)

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

    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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2023
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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