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Completed

NCT Number: NCT04017793

Mindfulness-Associated Brain Changes in Adults With Autism

The purpose of this study to measure brain functioning before and after stress-reduction classes to better understand how symptom improvements relate to brain functioning in adults with ASD (Autism Spectrum Disorder). Participants will be randomly assigned to one of two stress reduction classes that will meet once a week for 8 weeks. One group will complete a structured training program called Mindfulness Based Stress Reduction (MBSR) that involves teaching about increased mindfulness strategies and gentle stretching. The other group will review relaxation techniques and other stress reduction strategies and will include social support. Structural and functional MRI, EEG, and behavioral self-report data will be collected to understand more about how the brain changes in subtle ways when people feel better and are more aware of their emotional state.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Tempe, Arizona, 85281, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 89 years old, with a special focus on adults with ASD who are going to college given the additional stress of this phase in life. We are recruiting participants across a broad age range in order to maximize our ability to inform interventions for adults with ASD. The upper age limit of 89 years was selected so a de-identified dataset can be created with all participant ages included.
  • ASD diagnosis via gold-standard diagnostic assessments (Autism Diagnostic Observation Schedule-2).
  • Must be able to attend at least 7 of the 8 weekly intervention classes.
  • English speaking: Participants must be English-speaking because the screening and behavioral measures are in English (including the intelligence estimate).

Exclusion criteria

  • Participants with Intelligence Quotient (IQ) scores <70 will be excluded to minimize variability due to general cognitive functioning.
  • Report of any major medical illnesses, histories of seizures, or head trauma with loss of consciousness. These health factors can cause brain changes that would confound findings.
  • Concerns that the participant may not be able to complete the MRI neuroimaging requirements for the study, including claustrophobia or metal objects within the participant's body or eyes. Implanted metal objects may create a safety hazard in the powerful magnetic field during MRI imaging.
  • Pregnant women. MRI has no known effects on pregnancy or fertility. However, since we are not 100% certain MRI has no effects on a developing fetus, women who are pregnant may not participate in this study.

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

Structured 8-week training program teaching about increased mindfulness strategies and gentle stretching.

Relaxation group

Behavioral

8-weekly group discussion meetings reviewing relaxation techniques and other stress reduction strategies with an emphasis on social support.

Primary outcomes

  1. Beck Depression Inventory - II

    Time frame: Baseline; Pre-intervention

    21-question multiple-choice self-report inventory for measuring depression severity. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores ranging from 0-13 indicate minimal depression. Raw scores ranging from 14-19 indicate mild depression. Raw scores of 20-28 indicate moderate depression and scores of 29-63 indicate severe depression.

  2. Beck Depression Inventory - 2

    Time frame: Post-intervention (~10 weeks)

    21-question multiple-choice self-report inventory for measuring depression severity. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores ranging from 0-13 indicate minimal depression. Raw scores ranging from 14-19 indicate mild depression. Raw scores of 20-28 indicate moderate depression and scores of 29-63 indicate severe depression.

  3. State-Trait Anxiety Inventory

    Time frame: Baseline; Pre-intervention

    Self-report inventory measuring two types of anxiety. 20 items assess the temporary condition of state anxiety, or anxiety about an event, and an additional 20 items assess the more general trait anxiety, or anxiety level as a personal characteristic. Items are rated on a 4-point frequency scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

  4. State-Trait Anxiety Inventory

    Time frame: Post-intervention (~10 weeks)

    Self-report inventory measuring two types of anxiety. 20 items assess the temporary condition of state anxiety, or anxiety about an event, and an additional 20 items assess the more general trait anxiety, or anxiety level as a personal characteristic. Items are rated on a 4-point frequency scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Secondary outcomes

  1. World Health Organization Quality of Life

    Time frame: Baseline; Pre-intervention and Post-intervention

    Measures physical, psychological, social, and environmental domains of quality of life with added assessments of disability-related and autism-specific quality of life.

Other outcomes

  1. Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task

    Time frame: Baseline; Pre-intervention

    Measure of brain activation during an fMRI task validated by Sterling (2006) requiring judgments on adjectives relating to a self-condition or judgments on whether an adjective is positively valanced.

  2. Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task

    Time frame: Post-intervention (~10 weeks)

    Measure of brain activation during an fMRI task validated by Sterling (2006) requiring judgments on adjectives relating to a self-condition or judgments on whether an adjective is positively valanced.

  3. Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task

    Time frame: Baseline; Pre-intervention

    Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces.

  4. Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task

    Time frame: Post-intervention (~10 weeks)

    Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces.

  5. Event-Related Potentials (ERP) measured during regulation of affective responses

    Time frame: Baseline; Pre-intervention

    Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli.

  6. Event-Related Potentials (ERP) measured during regulation of affective responses

    Time frame: Post-intervention (~10 weeks)

    Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Banner Alzheimer's Institute
  • Southwest Autism Research and Resource Center (SARRC)

Registry information

Official study title

The Neural Changes Associated With a Mindfulness Intervention for Adults With Autism Spectrum Disorder

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Jul 12, 2019
Registry last updated
Jan 15, 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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