Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is studying how well two different stress-reduction classes help adults with ASD manage symptoms by looking at changes in brain functioning.
Eligible Conditions
- Autistic Disorder
- Autism Spectrum Disorders
- Autism Spectrum Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 1 Secondary · Reporting Duration: Post-intervention (~10 weeks)
Baseline; Pre-intervention
Beck Depression Inventory - II
Baseline; Pre-intervention and Post-intervention
World Health Organization Quality of Life
Post-intervention (~10 weeks)
Beck Depression Inventory - 2
Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task
Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task
Event-Related Potentials (ERP) measured during regulation of affective responses
State-Trait Anxiety Inventory
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Mindfulness Based Stress Reduction Program
1 of 2
Relaxation Group
1 of 2
Active Control
108 Total Participants · 2 Treatment Groups
Primary Treatment: Mindfulness Based Stress Reduction Program · No Placebo Group · N/A
Mindfulness Based Stress Reduction Program
Behavioral
ActiveComparator Group · 1 Intervention: Mindfulness Based Stress Reduction · Intervention Types: BehavioralRelaxation Group
Behavioral
ActiveComparator Group · 1 Intervention: Relaxation Group · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-intervention (~10 weeks)
Who is running the clinical trial?
Banner Alzheimer's InstituteOTHER
6 Previous Clinical Trials
2,396 Total Patients Enrolled
Arizona State UniversityLead Sponsor
238 Previous Clinical Trials
89,018 Total Patients Enrolled
11 Trials studying Autistic Disorder
1,587 Patients Enrolled for Autistic Disorder
Southwest Autism Research and Resource Center (SARRC)UNKNOWN
1 Previous Clinical Trials
12,000 Total Patients Enrolled
Brittany B Braden, PhDPrincipal InvestigatorAssistant Professor; Autism and Brain Aging Laboratory Director
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- 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. 2021 Oct 16. doi: 10.1007/s11136-021-03013-x. [Epub ahead of print]
- 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.
- Brittany Blair Braden 2019. "Mindfulness-Associated Brain Changes in Adults With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04017793.
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