Mindfulness-Associated Brain Changes in Adults With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04017793
• Other study ID #: IRB # STUDY00007227
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Mindfulness Based Stress Reduction
Structured 8-week training program teaching about increased mindfulness strategies and gentle stretching.
• Relaxation Group
8-weekly group discussion meetings reviewing relaxation techniques and other stress reduction strategies with an emphasis on social support.

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	Banner Alzheimer's Institute, Southwest Autism Research and Resource Center (SARRC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task	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.	Baseline; Pre-intervention
Other	Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task	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.	Post-intervention (~10 weeks)
Other	Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task	Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces.	Baseline; Pre-intervention
Other	Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task	Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces.	Post-intervention (~10 weeks)
Other	Event-Related Potentials (ERP) measured during regulation of affective responses	Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli.	Baseline; Pre-intervention
Other	Event-Related Potentials (ERP) measured during regulation of affective responses	Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli.	Post-intervention (~10 weeks)
Primary	Beck Depression Inventory - II	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.	Baseline; Pre-intervention
Primary	Beck Depression Inventory - 2	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.	Post-intervention (~10 weeks)
Primary	State-Trait Anxiety Inventory	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.	Baseline; Pre-intervention
Primary	State-Trait Anxiety Inventory	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.	Post-intervention (~10 weeks)
Secondary	World Health Organization Quality of Life	Measures physical, psychological, social, and environmental domains of quality of life with added assessments of disability-related and autism-specific quality of life.	Baseline; Pre-intervention and Post-intervention