MeditationMDMS3NCT02313779
Meditation and Decision Making Study III
A study testing Lovingkindness Meditation (LKM) and Mindfulness Meditation in people with Meditation, run by Barbara L. Fredrickson, PhD at 1 site in United States.
Trial summary
The overarching goal of the proposed research is to investigate the role of emotions in facilitating successful lifestyle change, defined as healthy behavioral decisions repeated daily, or near daily. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Meditation
- What is being tested?
- Lovingkindness Meditation (LKM) and Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2015
- 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 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent in written and spoken English, with a high school reading level
- Willingness or interest in learning to meditate
- Computer literate with internet access
Who cannot join
- Individuals who are able to read Chinese logographs
- Individuals who have or have had a regular meditation practice, defined as having attended a 6-week or longer meditation class, practicing meditation at least 3 days a week for up to 6-weeks.
- Individuals with allergies to adhesive materials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nonconscious Affective and Physiological Mediators of Behavioral Decision Making Study 3
The overarching goal of the proposed research is to investigate the role of emotions in facilitating successful lifestyle change, defined as healthy behavioral decisions repeated daily, or near daily.
Participants are asked to make two lab visits during the course of four weeks to complete electronic questionnaires, be monitored for psychophysiological activity (e.g. heart rate, blood pressure, respiration), and listen to a guided meditation audio track. Additionally, between the two visits participants will be asked to complete weekly surveys that ask about daily meditation practice (outside of the lab) and general emotions.
- Conditions
- Meditation
- Being tested
- Lovingkindness Meditation (LKM), Mindfulness Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovingkindness Meditation (LKM)Behavioural
Compassionate behavior training (REVISE)
Mindfulness MeditationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Neutral | Placebo comparator | Reading passage about brain function which is masked as a news article. Receives: Behavioral: Lovingkindness Meditation (LKM); Behavioral: Mindfulness Meditation |
| Lovingkindness Meditation (LKM) | Experimental | Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod. Receives: Behavioral: Lovingkindness Meditation (LKM) |
| Mindfulness Meditation | Placebo comparator | Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod. Receives: Behavioral: Mindfulness Meditation |
| Positivity | Experimental | Reading passage about prioritizing positive emotions which is masked as a news article. Receives: Behavioral: Lovingkindness Meditation (LKM); Behavioral: Mindfulness Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in positive emotions (as measured by the Modified Daily Emotions Scale)
Modified Daily Emotions Scale (mDES) - This measure of explicit positive affect has been successfully used by the PI in multiple studies to detect changes in positive emotion. Previous work by the PI found that Cronbach's alpha coefficient for the mDES positive emotion composite variable was 0.93 in sample of mid-life community adults similar to those anticipated for this study.
Measured: Baseline and Weeks 1, 2, and 3
Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure)
Affect Misattribution Procedure (AMP) - This measure of nonconscious incentive salience has acceptable internal consistency for an indirect measure of affect (.69 - .90) and has been found to predict judgments and behavioral outcomes above and beyond self-report measures.
Measured: Baseline and Weeks 1, 2, and 3
Changes in meditation time
Self-reported meditation time recorded daily and weekly. In addition, meditation track play times will be recorded from the iPod.
Measured: Weeks 1, 2, and 3
Secondary outcomes (1)
Cardiac Vagal Tone
This measure of parasympathetic control over the heart has been positively associated with both emotional and social functioning. Previous work by the PI's team has found that baseline vagal tone predicts increased positive response to lovingkindness meditation (LKM), and that LKM in turn increases vagal tone.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MeditationStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara L. Fredrickson, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Barbara L. Fredrickson, PhD, University of North Carolina, Chapel Hill
- Investigators
- Barbara L Fredrickson, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313779
- Sponsor's protocol ID
- 12-2428
- Other IDs
- R01AT007884-01
- Acronym
- MDMS3
- Status last verified
- Jul 2016
- First submitted
- 8 Dec 2014
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fredrickson BL, Cohn MA, Coffey KA, Pek J, Finkel SM. Open hearts build lives: positive emotions, induced through loving-kindness meditation, build consequential personal resources. J Pers Soc Psychol. 2008 Nov;95(5):1045-1062. doi: 10.1037/a0013262.
PubMed 18954193Carmody J, Baer RA, L B Lykins E, Olendzki N. An empirical study of the mechanisms of mindfulness in a mindfulness-based stress reduction program. J Clin Psychol. 2009 Jun;65(6):613-26. doi: 10.1002/jclp.20579.
PubMed 19267330Johnson KJ, Waugh CE, Fredrickson BL. Smile to see the forest: Facially expressed positive emotions broaden cognition. Cogn Emot. 2010 Feb 19;24(2):299-321. doi: 10.1080/02699930903384667.
PubMed 23275681Payne BK, Cheng CM, Govorun O, Stewart BD. An inkblot for attitudes: affect misattribution as implicit measurement. J Pers Soc Psychol. 2005 Sep;89(3):277-93. doi: 10.1037/0022-3514.89.3.277.
PubMed 16248714
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonconscious Affective and Physiological Mediators of Behavioral Decision Making Study 3
- ClinicalTrials.gov ID
- NCT02313779
- Acronym / sponsor ID
- MDMS3 / 12-2428
- Conditions
- Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Barbara L. Fredrickson, PhDUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Dec 2014 (estimated)
- 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 overarching goal of the proposed research is to investigate the role of emotions in facilitating successful lifestyle change, defined as healthy behavioral decisions repeated daily, or near daily.
Participants are asked to make two lab visits during the course of four weeks to complete electronic questionnaires, be monitored for psychophysiological activity (e.g. heart rate, blood pressure, respiration), and listen to a guided meditation audio track. Additionally, between the two visits participants will be asked to complete weekly surveys that ask about daily meditation practice (outside of the lab) and general emotions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neutral | Placebo comparator | Behavioral: Lovingkindness Meditation (LKM), Behavioral: Mindfulness MeditationReading passage about brain function which is masked as a news article. |
| Lovingkindness Meditation (LKM) | Experimental | Behavioral: Lovingkindness Meditation (LKM)Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod. |
| Mindfulness Meditation | Placebo comparator | Behavioral: Mindfulness MeditationMindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod. |
| Positivity | Experimental | Behavioral: Lovingkindness Meditation (LKM), Behavioral: Mindfulness MeditationReading passage about prioritizing positive emotions which is masked as a news article. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fluent in written and spoken English, with a high school reading level
- Willingness or interest in learning to meditate
- Computer literate with internet access
Key exclusion criteria (3 listed)
- Individuals who are able to read Chinese logographs
- Individuals who have or have had a regular meditation practice, defined as having attended a 6-week or longer meditation class, practicing meditation at least 3 days a week for up to 6-weeks.
- Individuals with allergies to adhesive materials
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 |
|---|---|---|
| Lovingkindness Meditation (LKM)Compassionate behavior training (REVISE) | Behavioural | Lovingkindness Meditation (LKM), Neutral, Positivity |
| Mindfulness Meditation | Behavioural | Mindfulness Meditation, Neutral, Positivity |
Primary outcome
Change in positive emotions (as measured by the Modified Daily Emotions Scale)
Time frame: Baseline and Weeks 1, 2, and 3
Modified Daily Emotions Scale (mDES) - This measure of explicit positive affect has been successfully used by the PI in multiple studies to detect changes in positive emotion. Previous work by the PI found that Cronbach's alpha coefficient for the mDES positive emotion composite variable was 0.93 in sample of mid-life community adults similar to those anticipated for this study.
Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure)
Time frame: Baseline and Weeks 1, 2, and 3
Affect Misattribution Procedure (AMP) - This measure of nonconscious incentive salience has acceptable internal consistency for an indirect measure of affect (.69 - .90) and has been found to predict judgments and behavioral outcomes above and beyond self-report measures.
Changes in meditation time
Time frame: Weeks 1, 2, and 3
Self-reported meditation time recorded daily and weekly. In addition, meditation track play times will be recorded from the iPod.
1 secondary outcome
Cardiac Vagal Tone
Time frame: Baseline
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 15 Jul 2016.
- Background: PubMed 18954193Fredrickson BL, Cohn MA, Coffey KA, Pek J, Finkel SM. Open hearts build lives: positive emotions, induced through loving-kindness meditation, build consequential personal resources. J Pers Soc Psychol. 2008 Nov;95(5):1045-1062. doi: 10.1037/a0013262.
- Background: PubMed 19267330Carmody J, Baer RA, L B Lykins E, Olendzki N. An empirical study of the mechanisms of mindfulness in a mindfulness-based stress reduction program. J Clin Psychol. 2009 Jun;65(6):613-26. doi: 10.1002/jclp.20579.
- Background: PubMed 23275681Johnson KJ, Waugh CE, Fredrickson BL. Smile to see the forest: Facially expressed positive emotions broaden cognition. Cogn Emot. 2010 Feb 19;24(2):299-321. doi: 10.1080/02699930903384667.
- Background: PubMed 16248714Payne BK, Cheng CM, Govorun O, Stewart BD. An inkblot for attitudes: affect misattribution as implicit measurement. J Pers Soc Psychol. 2005 Sep;89(3):277-93. doi: 10.1037/0022-3514.89.3.277.
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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.
Barbara L Fredrickson, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lovingkindness Meditation (LKM) and Mindfulness Meditation in people with Meditation, run by Barbara L. Fredrickson, PhD 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 3 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 15 Jul 2016. 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. Some participants in this study may receive a placebo. 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?
Change in positive emotions (as measured by the Modified Daily Emotions Scale) (time frame: Baseline and Weeks 1, 2, and 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02313779, which also lists 4 linked publications.
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 15 Jul 2016.