Mindfulness-Associated Brain Changes in Adults With Autism

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Relaxation Group

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mindfulness Based Stress Reduction Program	Behavioral: Mindfulness Based Stress Reduction; Structured 8-week training program teaching about increased mindfulness strategies and gentle stretching.
Active Comparator: Relaxation Group	Behavioral: Relaxation Group; 8-weekly group discussion meetings reviewing relaxation techniques and other stress reduction strategies with an emphasis on social support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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)
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
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)

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Southwest Autism Research and Resource Center (SARRC); Banner Alzheimer's Institute
• Investigators: Principal Investigator: Brittany B Braden, PhD, Assistant Professor; Autism and Brain Aging Laboratory Director

Publications and helpful links

General Publications

• Braden BB, Pagni BA, Monahan L, Walsh MJM, Dixon MV, Delaney S, Ballard L, Ware JE Jr. Quality of life in adults with autism spectrum disorder: influence of age, sex, and a controlled, randomized mindfulness-based stress reduction pilot intervention. Qual Life Res. 2022 May;31(5):1427-1440. doi: 10.1007/s11136-021-03013-x. Epub 2021 Oct 16.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: IRB # STUDY00007227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
• IPD Sharing Time Frame: Data will be available upon request starting 6 months after publication and will remain available for 2 years.
• IPD Sharing Access Criteria: Data requests should be submitted to Dr. Braden at bbbraden@asu.edu and must include study aims and purpose and a detailed analysis plan describing how the data will be used. Requests will be reviewed by Dr. Braden and access to the data will be made available through a secure link to download the requested data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No