- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03456505
Dissecting De-automatization
September 28, 2018 updated by: Adam Hanley, University of Utah
Dissecting De-automatization: The Effect of Mindfulness Training on Unconscious Habit Formation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-60,
- willingness to participate in study interventions and assessments.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness
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).
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A researcher will guide participants through 5 mindfulness meditations, each lasting 11 minutes in length.
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Active Comparator: Active Listening
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.
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A researcher will read participants 5 selections from The Natural History of Selborne, each lasting 11 minutes in length.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conditioned Eyeblink Frequency
Time Frame: 9 minutes
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Between group differences in the frequency of conditioned eyeblinks over the six reinforcement blocks.
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9 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Emotion Regulation Task
Time Frame: 5 minutes
|
Between group differences in affective change occasioned by savoring positive images will be measured by comparing increases in self-reported positive affect (5-point Likert scale) from pre- to post- positive image, viewing block.
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5 minutes
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Negative Emotion Regulation Task
Time Frame: 5 minutes
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Between group differences in affective change occasioned by positively reappraising negative images will be measured by comparing increases in self-reported negative affect (5-point Likert scale) from pre- to post- negative image, viewing block.
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5 minutes
|
Self-Transcendence (NADA-State)
Time Frame: 2 minutes
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Between group differences in the degree to which mindfulness training alters participants' sense of self as measured by the nondaul awareness dimension assessment's (NADA) state form.
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2 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2017
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
January 12, 2018
First Submitted That Met QC Criteria
February 28, 2018
First Posted (Actual)
March 7, 2018
Study Record Updates
Last Update Posted (Actual)
October 1, 2018
Last Update Submitted That Met QC Criteria
September 28, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- IRB_00088540
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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