Autism Spectrum DisorderNCT04017793
Mindfulness-Associated Brain Changes in Adults With Autism
A study testing Mindfulness Based Stress Reduction and Relaxation Group in people with Autism Spectrum Disorder, run by Arizona State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Mindfulness Based Stress Reduction and Relaxation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Mindfulness Based Stress Reduction, Relaxation Group
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
Structured 8-week training program teaching about increased mindfulness strategies and gentle stretching.
Relaxation GroupBehavioural
8-weekly group discussion meetings reviewing relaxation techniques and other stress reduction strategies with an emphasis on social support.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction Program | Active comparator | Not described Receives: Behavioral: Mindfulness Based Stress Reduction |
| Relaxation Group | Active comparator | Not described Receives: Behavioral: Relaxation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (~10 weeks)
Secondary outcomes (1)
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.
Measured: Baseline; Pre-intervention and Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start6 May 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest Autism Research and Resource Center (SARRC), Banner Alzheimer's Institute
- Responsible party
- Principal investigator, Brittany Blair Braden, Arizona State University
- Investigators
- Brittany B Braden, PhD, Principal investigator, Assistant Professor; Autism and Brain Aging Laboratory Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017793
- Sponsor's protocol ID
- IRB # STUDY00007227
- Status last verified
- Jan 2026
- First submitted
- 9 Jul 2019
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
Publications
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.
PubMed 36990468Braden 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.
PubMed 34655389
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Changes Associated With a Mindfulness Intervention for Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04017793
- Acronym / sponsor ID
- IRB # STUDY00007227
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Southwest Autism Research and Resource Center (SARRC), Banner Alzheimer's Institute
- Study start
- 6 May 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction Program | Active comparator | Behavioral: Mindfulness Based Stress Reduction |
| Relaxation Group | Active comparator | Behavioral: Relaxation Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress ReductionStructured 8-week training program teaching about increased mindfulness strategies and gentle stretching. | Behavioural | Mindfulness Based Stress Reduction Program |
| Relaxation Group8-weekly group discussion meetings reviewing relaxation techniques and other stress reduction strategies with an emphasis on social support. | Behavioural | Relaxation Group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
World Health Organization Quality of Life
Time frame: Baseline; Pre-intervention and Post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 36990468Pagni 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.
- Derived from this study: PubMed 34655389Braden 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.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany B Braden, PhD principal investigator
Assistant Professor; Autism and Brain Aging Laboratory Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction and Relaxation Group in people with Autism Spectrum Disorder, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory - II (time frame: Baseline; Pre-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04017793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.