Neural Mechanisms of Mindfulness

NCT03466164 | Completed DMC

• 1 other identifier: 1R21AT009483
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Psychological well-being

  Baseline (0 months), Post (through study completion, an average of 3 months)

• Mindfulness

  Baseline (0 months), Post (through study completion, an average of 3 months)

• Anxiety

  Baseline (0 months), Post (through study completion, an average of 3 months)

• Positive and Negative Mood

  Baseline (0 months), Post (through study completion, an average of 3 months)

Study Arms (2)

Behavioral: Mindfulness Based Stress Reduction Program

EXPERIMENTAL

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

Control MZ

NO INTERVENTION

Control MZ twin will complete 2 testing sessions without intervention.

Interventions

Mindfulness Based Stress Reduction Program BEHAVIORAL

8 week, 10-session course of mindfulness training

Also known as: MBSR

Behavioral: Mindfulness Based Stress Reduction Program

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63130, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: discordant twin design

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: March 15, 2018
• Study Start: July 3, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

US (1)