Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness-Associated Brain Changes in Adults With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04017793
Recruitment Status : Active, not recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Southwest Autism Research and Resource Center (SARRC)
Information provided by (Responsible Party):
Brittany Blair Braden, Arizona State University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Mindfulness Based Stress Reduction Behavioral: Relaxation Group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Neural Changes Associated With a Mindfulness Intervention for Adults With Autism Spectrum Disorder
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : May 6, 2020
Estimated Study Completion Date : May 6, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Beck Depression Inventory - II [ Time Frame: Baseline; Pre-intervention ]
    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.

  2. Beck Depression Inventory - 2 [ Time Frame: Post-intervention (~10 weeks) ]
    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.

  3. State-Trait Anxiety Inventory [ Time Frame: Baseline; Pre-intervention ]
    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.

  4. State-Trait Anxiety Inventory [ Time Frame: Post-intervention (~10 weeks) ]
    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.


Other Outcome Measures:
  1. Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task [ Time Frame: Baseline; Pre-intervention ]
    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.

  2. Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task [ Time Frame: Post-intervention (~10 weeks) ]
    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.

  3. Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task [ Time Frame: Baseline; Pre-intervention ]
    Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces.

  4. Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task [ Time Frame: Post-intervention (~10 weeks) ]
    Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces.

  5. Event-Related Potentials (ERP) measured during regulation of affective responses [ Time Frame: Baseline; Pre-intervention ]
    Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli.

  6. Event-Related Potentials (ERP) measured during regulation of affective responses [ Time Frame: Post-intervention (~10 weeks) ]
    Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017793


Locations
Layout table for location information
United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85281
Sponsors and Collaborators
Arizona State University
Southwest Autism Research and Resource Center (SARRC)
Investigators
Layout table for investigator information
Principal Investigator: Brittany B Braden, PhD Assistant Professor; Autism and Brain Aging Laboratory Director

Layout table for additonal information
Responsible Party: Brittany Blair Braden, Assistant Professor; Autism and Brain Aging Laboratory Director, Arizona State University
ClinicalTrials.gov Identifier: NCT04017793     History of Changes
Other Study ID Numbers: IRB # STUDY00007227
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
Supporting Materials: Study Protocol
Informed Consent Form (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders