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CompletedNCT03456505Updated Oct 1, 2018

Dissecting De-automatization

An interventional study of Mindfulness Meditation Training and Active Listening in Mindfulness, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-01.

Sponsored by University of Utah · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mindfulness
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention, or a history of meditation practice,
  2. Learning disability, significant memory problems or significant attentional disruptions as determined by self-report,
  3. History of head injury resulting in loss of consciousness.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
53 participants (actual)

Study arms

  • 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).

    Behavioral: Mindfulness Meditation Training

  • 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.

    Behavioral: Active Listening

Interventions

  • BehavioralMindfulness Meditation Training

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

  • BehavioralActive Listening

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

05

What researchers measure

Primary outcomes

  1. Conditioned Eyeblink Frequency

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

    Time frame: 9 minutes

Secondary outcomes

  1. Positive Emotion Regulation Task

    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.

    Time frame: 5 minutes

  2. Negative Emotion Regulation Task

    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.

    Time frame: 5 minutes

  3. Self-Transcendence (NADA-State)

    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.

    Time frame: 2 minutes

06

Study locations

1 site
  • University of Utah
    Salt Lake City, Utah 84112, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03456505
Lead sponsor
University of Utah
Responsible party
Adam Hanley (Principal Investigator, University of Utah) — Principal investigator
First posted
Mar 7, 2018
Start date
Aug 15, 2017
Primary completion
Jun 1, 2018
Completion
Jul 1, 2018
Last update
Oct 1, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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