Clinical trial NCT04017793: Mindfulness-Associated Brain Changes in Adults With Autism
Official title: The Neural Changes Associated With a Mindfulness Intervention for Adults With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Southwest Autism Research and Resource Center (SARRC)
name: Banner Alzheimer's Institute
First posted: 2019-07-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Beck Depression Inventory - II
timeFrame: Baseline; Pre-intervention
measure: Beck Depression Inventory - 2
timeFrame: Post-intervention (~10 weeks)
measure: State-Trait Anxiety Inventory
timeFrame: Baseline; Pre-intervention
measure: State-Trait Anxiety Inventory
timeFrame: Post-intervention (~10 weeks)
Secondary outcomes:
measure: World Health Organization Quality of Life
timeFrame: Baseline; Pre-intervention and Post-intervention
Other outcomes:
measure: Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task
timeFrame: Baseline; Pre-intervention
measure: Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task
timeFrame: Post-intervention (~10 weeks)
measure: Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task
timeFrame: Baseline; Pre-intervention
measure: Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task
timeFrame: Post-intervention (~10 weeks)
measure: Event-Related Potentials (ERP) measured during regulation of affective responses
timeFrame: Baseline; Pre-intervention
measure: Event-Related Potentials (ERP) measured during regulation of affective responses
timeFrame: Post-intervention (~10 weeks)
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Assistant Professor; Autism and Brain Aging Laboratory Director
name: Brittany B Braden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.