Neural Mechanisms of Mindfulness

NCT ID: NCT03466164

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-03
• Study Completion Date: 2020-03-31

Brief Summary

This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Participants will complete two sets of cognitive tasks during functional magnetic resonance imaging (fMRI) and either be assigned to an MT intervention between scan sets or after scan sets.

Detailed Description

This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Although MT is rapidly gaining in popularity as a life-style intervention, there are still critical gaps in our understanding of its primary mechanism of action. Current theoretical frameworks suggest that MT operates by improving attentional control, emotional regulation, and self-awareness capabilities, potentially by targeting neuroplastic brain mechanisms of executive control. This suggests an important role for cognitive neuroscience research, but current work is still in its infancy, and subject to a number of well-recognized methodological and conceptual limitations. The proposed project aims to systematically remedy these limitations of prior MT research, by leveraging the unique opportunities offered by the Human Connectome Project (HCP), and on-going NIH R01-funded research. A key feature of the project is the use of a randomized, longitudinal discordant twin design, in which monozygotic (MZ; identical) twin pairs will be recruited, with one co-twin randomly assigned to the MT condition (mindfulness-based stress reduction, or MBSR; the most-validated and standardized form of MT instruction) and the other serving as a (wait-list) control. Each co-twin will undergo extensive behavioral and MRI neuroimaging assessments in a pre/post fashion, before and after the MT (or no-contact control) intervention, to test for specific MT-related effects. The discordant twin design, though never previously employed in an MT context, is widely recognized as one of the strongest for causal inference, since it avoids many of the challenges and confounds associated with inadequately matched control groups, and enables twin-pair focused analyses, which greatly increase statistical power. The investigators will use this design to investigate theoretically-focused hypotheses that stem from a guiding framework regarding the neural mechanisms of cognitive control. Specifically, using a newly developed cognitive control task battery, the investigator will test the counter-intuitive hypothesis that MT produces an enhancement in the neural mechanism and circuits associated with reactive (rather than proactive) control. An additional subset of MZ twin participants will undergo retesting with the original HCP protocol, in order to provide a comprehensive assessment and comparison of MT effect sizes across multiple domains of cognitive and brain function. Success in this project will have high relevance for public health, by providing innovative experimental tools and a novel theoretical framework from which to empirically evaluate and better understand the potential impact of MT programs as lifestyle interventions for enhancing psychological well-being in healthy populations.

Conditions

Cognitive Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Behavioral: Mindfulness Based Stress Reduction Program

Mindfulness-Based Stress Reduction MZ: identical (monozygotic; MZ) twins are tested in a pre-post manner, with only one twin randomly assigned to MT in between the two testing sessions

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction Program

Intervention Type: BEHAVIORAL

8 week, 10-session course of mindfulness training

Control MZ

Control MZ twin will complete 2 testing sessions without intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Based Stress Reduction Program

8 week, 10-session course of mindfulness training

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR

Eligibility Criteria

Inclusion Criteria

• monozygotic (MZ) or dizygotic (DZ) twins
• age range 22 to 45 years
• native English speaker

Exclusion Criteria

• current psychiatric diagnosis
• taking psychoactive medication
• medical disorder that affects cognitive or motor function
• present or past head injury with documented neurological sequelae, and/or causing loss of consciousness.
• Pregnancy
• Claustrophobia
• Metallic objects
• Heart rhythm abnormalities or pacemaker
• Premature birth (before 34 weeks)

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

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Other Identifiers

1R21AT009483

Identifier Type: NIH

Identifier Source: org_study_id

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