MindfulnessNCT03456505
Dissecting De-automatization
A study testing Mindfulness Meditation Training and Active Listening in people with Mindfulness, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Mindfulness Meditation Training and Active Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60,
- willingness to participate in study interventions and assessments.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mindfulness
- Being tested
- Mindfulness Meditation Training, Active Listening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation TrainingBehavioural
A researcher will guide participants through 5 mindfulness meditations, each lasting 11 minutes in length.
Active ListeningBehavioural
A researcher will read participants 5 selections from The Natural History of Selborne, each lasting 11 minutes in length.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Active Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Eyeblink Frequency
Between group differences in the frequency of conditioned eyeblinks over the six reinforcement blocks.
Measured: 9 minutes
Secondary outcomes (3)
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.
Measured: 5 minutes
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.
Measured: 5 minutes
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start15 Aug 2017
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456505
- Sponsor's protocol ID
- IRB_00088540
- Status last verified
- Sep 2018
- First submitted
- 12 Jan 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting De-automatization: The Effect of Mindfulness Training on Unconscious Habit Formation
- ClinicalTrials.gov ID
- NCT03456505
- Acronym / sponsor ID
- IRB_00088540
- Conditions
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness Meditation TrainingParticipants 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). |
| Active Listening | Active comparator | Behavioral: Active ListeningParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-60,
- willingness to participate in study interventions and assessments.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation TrainingA researcher will guide participants through 5 mindfulness meditations, each lasting 11 minutes in length. | Behavioural | Mindfulness |
| Active ListeningA researcher will read participants 5 selections from The Natural History of Selborne, each lasting 11 minutes in length. | Behavioural | Active Listening |
Primary outcome
Conditioned Eyeblink Frequency
Time frame: 9 minutes
Between group differences in the frequency of conditioned eyeblinks over the six reinforcement blocks.
3 secondary outcomes
Positive Emotion Regulation Task
Time frame: 5 minutes
Negative Emotion Regulation Task
Time frame: 5 minutes
Self-Transcendence (NADA-State)
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation Training and Active Listening in people with Mindfulness, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned Eyeblink Frequency (time frame: 9 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2018.