Mindfulness-Associated Brain Changes in Adults With Autism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mindfulness Based Stress Reduction Program

Group Type ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction

Intervention Type BEHAVIORAL

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

Relaxation Group

Group Type ACTIVE_COMPARATOR

Relaxation Group

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness Based Stress Reduction

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

Intervention Type BEHAVIORAL

Relaxation Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No