Neural Mechanisms of Mindfulness

Neural Mechanisms of Mindfulness: a Discordant Twin Design

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction Program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Mindfulness Based Stress Reduction Program; 8 week, 10-session course of mindfulness training; Other Names: MBSR
No Intervention: Control MZ; Control MZ twin will complete 2 testing sessions without intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proactive cognitive control composite behavioral score	The proactive composite variable consists aggregates the proactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from their behavioral performance score: [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.	Baseline (0 months), Post (through study completion, an average of 3 months)
Change in reactive cognitive control composite behavioral score	The reactive composite variable consists aggregates the reactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from their behavioral performance score : [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.	Baseline (0 months), Post (through study completion, an average of 3 months)
Change in proactive cognitive control composite brain imaging activation score	The proactive composite variable consists aggregates the proactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from the brain activation score in the region of interest (ROI): [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.	Baseline (0 months), Post (through study completion, an average of 3 months)
Change in reactive cognitive control composite brain imaging activation score	The reactive composite variable consists aggregates the reactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from the brain activation score in the region of interest (ROI): [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.	Baseline (0 months), Post (through study completion, an average of 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological well-being	Score on the Satisfaction with Life self-report measure	Baseline (0 months), Post (through study completion, an average of 3 months)
Mindfulness	Score on the MAAS self-report measure	Baseline (0 months), Post (through study completion, an average of 3 months)
Anxiety	Score on the STAI self-report measure	Baseline (0 months), Post (through study completion, an average of 3 months)
Positive and Negative Mood	Score on the PANAS self-report measure	Baseline (0 months), Post (through study completion, an average of 3 months)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1R21AT009483 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No