Mindfulness-Associated Brain Changes in Adults With Autism

NCT04017793 | Completed

• 1 other identifier: IRB # STUDY00007227
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• World Health Organization Quality of Life

  Baseline; Pre-intervention and Post-intervention

Other Outcomes (6)

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

  Baseline; Pre-intervention

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

  Post-intervention (~10 weeks)

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

  Baseline; Pre-intervention

Study Arms (2)

Mindfulness Based Stress Reduction Program

ACTIVE COMPARATOR

Behavioral: Mindfulness Based Stress Reduction

Relaxation Group

ACTIVE COMPARATOR

Behavioral: Relaxation Group

Interventions

Relaxation Group BEHAVIORAL

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

Relaxation Group

Mindfulness Based Stress Reduction BEHAVIORAL

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

Mindfulness Based Stress Reduction Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Banner Alzheimer's Institute: collaborator
• Arizona State University: lead
• Southwest Autism Research and Resource Center (SARRC): collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85281, United States

Location

Related Publications (2)

• Pagni BA, Hill E, Walsh MJM, Delaney S, Ogbeama D, Monahan L, Cook JR, Guerithault N, Dixon MV, Ballard L, Braden BB. Distinct and shared therapeutic neural mechanisms of mindfulness-based and social support stress reduction groups in adults with autism spectrum disorder. J Psychiatry Neurosci. 2023 Mar 29;48(2):E102-E114. doi: 10.1503/jpn.220159. Print 2023 Mar-Apr.

  PMID: 36990468 DERIVED

• 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.

  PMID: 34655389 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Brittany B Braden, PhD

  Assistant Professor; Autism and Brain Aging Laboratory Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor; Autism and Brain Aging Laboratory Director

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: May 6, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2024
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available upon request starting 6 months after publication and will remain available for 2 years.
• 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.

Locations

US (1)