NCT03456505

Brief Summary

The proposed study will assess the effects of mindfulness meditation training on an eye blink conditioning (EBC) task in a sample of novice meditators. This methodology will allow investigation of whether mindfulness interrupts classical conditioning through the process of de-automatization. Implicit learning rates, as reflective of unconscious habit formation and measured by the frequency of conditioned responses during the EBC, will be a main outcome of interest. The proposed study will also assess the effects of mindfulness meditation training on an emotion regulation (ER) task, with a specific focus on reappraisal of negative images and savoring of positive images.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

January 12, 2018

Last Update Submit

September 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Conditioned Eyeblink Frequency

    Between group differences in the frequency of conditioned eyeblinks over the six reinforcement blocks.

    9 minutes

Secondary Outcomes (3)

  • Positive Emotion Regulation Task

    5 minutes

  • Negative Emotion Regulation Task

    5 minutes

  • Self-Transcendence (NADA-State)

    2 minutes

Study Arms (2)

Mindfulness

EXPERIMENTAL

Participants randomly assigned to the mindfulness meditation condition will meet for five, 15-minute sessions, in which they will receive training in basic mindfulness skills (Wallace, 2006).

Behavioral: Mindfulness Meditation Training

Active Listening

ACTIVE COMPARATOR

Participants randomly assigned to the active listening condition will meet for five, 15-minute sessions, in which they will listen to Gilbert White's The Natural History of Selborne.

Behavioral: Active Listening

Interventions

A researcher will guide participants through 5 mindfulness meditations, each lasting 11 minutes in length.

Mindfulness

A researcher will read participants 5 selections from The Natural History of Selborne, each lasting 11 minutes in length.

Active Listening

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60,
  • willingness to participate in study interventions and assessments.

You may not qualify if:

  • Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention, or a history of meditation practice,
  • Learning disability, significant memory problems or significant attentional disruptions as determined by self-report,
  • History of head injury resulting in loss of consciousness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2018

First Posted

March 7, 2018

Study Start

August 15, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

October 1, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations