- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03920241
Cognition and Emotion in Meditation: A Comparison Between Mindfulness and Compassion Standardized Programs
Changes in Cognitive and Emotional Patterns Associated to Meditation and Compassion Training: Attentional Changes and Network Dynamics
The study is aimed at comparing the differential effects of two widely used standardized meditation programs: Mindfulness-Based Stress Reduction (MBSR) and Compassion Cultivation Training (CCT) in general population samples.
To address this goal, the effects will be measured by self-report questionnaires belonging to different domains (mindfulness, compassion, well-being, psychological distress, and psychological functioning) as well as information processing measures (i.e., Attentional Blink), and psychophysiological measures (EEG and EKG).
Changes will be assessed immediately after finishing the 8-week programs and through several inter-session assessments. Data analysis will include the mean change scores differences, as well as novel network analysis procedures to assess topological reorganization of constructs derived from the programs.
Study Overview
Status
Conditions
Detailed Description
The study has a twofold goal. Firstly, it will address whether the practice of different standardized meditation programs (MBSR and CCT) modify the distribution of limited attentional resources towards emotional information, measured by the performance in a variant of the Emotional Attentional Blink. Secondly, novel procedures of Network analysis will be used to examine whether the practice of different standardized meditation programs (mindfulness and compassion) impact on the network dynamics between mindfulness, compassion, well-being, psychological distress, and emotional and cognitive control constructs and how these constructs are eventually reorganized after the interventions.
There are two main corresponding hypotheses. First, meditation practice in general (both mindfulness and compassion) will change the attentional processing of emotional information, reflected by a significant reduction of the attentional blink deficit after the programs as compared to the performance of participants in matched Control group. Differences between both intervention groups will be analyzed. The second hypothesis states that, after meditation programs, the networks of these constructs will become topologically reorganized; more specifically, mindfulness, emotion regulation, and well-being constructs are expected to increase their centrality in the resulting network.
Procedure
The study will follow a pre-post design where participants will be blind to the aims of the study. Participants will be invited to participate at the moment they register in the official website offering the MBSR and CCT programs. After being recruited, those who accept to participate will fill out a brief online screening questionnaire on demographics and inclusion criteria and will sign an informed consent. Then participants will complete an online set of questionnaires (via Qualtrics software) of selected psychological domains associated to the main outcomes and variables studied in meditation literature (i.e., mindfulness, compassion, well-being, psychological distress, and emotional and cognitive control constructs). The online assessment will be completed the week before starting the program (baseline assessment) and during the week after the end of the MBSR (post-assessment). When necessary, reminders will be scheduled for those participants who have not completed the questionnaires. Each pre and post online evaluation will last approximately 45 minutes.
Participants are invited to attend a one-hour experimental session (i.e. Attentional Blink task) within the week before starting the meditation program. After completing a second informed consent, participants will fill out a set of questionnaires with mood (EEE), mindfulness (SM) and compassion (S_SC) state measure. Participants then will begin the Emotional Attentional Blink task divided into three blocks with a 1-minute break between the blocks. At the end of the task, participants will complete the "state measures" again and the session will end. After this lab session, participants will attend one of the two 8-week standardized meditation programs (MBSR or CCT). Finally, the same procedure will be followed for the post-experimental session within the week after the end of the programs. Each pre-post experimental session will last approximately one hour. After completing the post-treatment assessments, participants will be debriefed and will receive an individualized report of their questionnaires scores and the purposes of the study.
Programs description
The Mindfulness-Based Stress Reduction (MBSR) is an 8-week standardized program consisted of 2.5-hours of face-to-face weekly sessions, and 45 minutes of daily home formal and informal practices. Training will be conducted in groups of 20-30 participants. During the program, different mindfulness practices are performed, including focused attention on the breath, open monitoring of awareness in body-scanning, prosocial meditation (i.e. loving kindness and compassion) and gentle yoga.
The Compassion Cultivation Training (CCT) is also an 8-week standardized program consisting of 2.5-hours of face-to-face weekly sessions and 30 minutes of daily home formal and informal practices. Training will be conducted in groups of 20-30 participants. The CCT consists of six sequential steps: 1) Settling the mind and learn how to focus it; 2) Loving-kindness and compassion for a loved one practice; 3) Loving-kindness and compassion for oneself practice; 4) compassion toward others, embracing shared common humanity and developing appreciation of others; 5) compassion toward others including all beings; and 6) active compassion practices (Tonglen) which involve explicit evocation of the altruistic wish to do something about others' suffering. Finally, participants learn an integrative compassion practice combining the six essential elements into an integrative compassion meditation practice.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain, 28223
- School of Psychology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or more
- Fluency in oral and written Spanish
Exclusion Criteria:
- Having any current of serious psychological disorder or substance abuse / dependence.
- Being currently enrolled in another standardized meditation program
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
MBSR group
Attendants to Mindfulness-Based Stres Reduction programs offered to the community by Complutense University
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The MBSR is an 8-week standardized program (Kabat-Zinn, 1990) consisted of 2.5-hour of face-to-face weekly sessions, and 45 minutes of daily home formal and informal practices. Training will be conducted in groups of 20-30 participants. During the program, different mindfulness practices are performed, including focused attention on the breath, open monitoring of awareness in body-scanning, prosocial meditation (i.e. loving kindness and compassion) and gentle yoga. Training is delivered by certificated instructors by the University of Massachusetts Centre for Mindfulness (https://www.umassmed.edu/cfm/).
Other Names:
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CCT group
Attendants to Compassion Cultivation Training programs offered to the community by Complutense University
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The CCT is an 8-week standardized program (Jinpa, 2010; Jazaieri et al. 2013, 2014) consisting of 2.5-hour of face-to-face weekly sessions and 30 minutes of daily home formal and informal practices. Training will be conducted in groups of 20-30 participants. The CCT consists of six sequential steps: 1) Settling the mind and learn how to focus it; 2) Loving kindness and compassion for a loved one practice; 3) Loving kindness and compassion for oneself practice; 4) compassion toward others, embracing shared common humanity and developing appreciation of others; 5) compassion toward others including all beings; and 6) active compassion practices (Tonglen) which involve explicit evocation of the altruistic wish to do something about others' suffering. CCT program is delivered by certificated instructors by the University of Stanford Centre for Compassion and Altruism Research and Education (http://ccare.stanford.edu/).
Other Names:
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Control group
Control group matched by age, gender, and meditation experience.
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A group of participants, matched by age, gender, and meditation experience is selected to compare their performance on experimental lab tasks in relation to the MBSR and CCT participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in attention performance (Lab measures)
Time Frame: Pre- and post-intervention assessments (baseline and 8 weeks later)
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Attentional blink (accuracy emotion identification)
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Pre- and post-intervention assessments (baseline and 8 weeks later)
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Change from Baseline in brain activity (Lab measures)
Time Frame: Pre- and post-intervention assessments (baseline and 8 weeks later)
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EEG (frontal lobe activity)
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Pre- and post-intervention assessments (baseline and 8 weeks later)
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Change from Baseline in heart activity (Lab measures)
Time Frame: Pre- and post-intervention assessments (baseline and 8 weeks later)
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EKG (Heart rate variability)
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Pre- and post-intervention assessments (baseline and 8 weeks later)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mindfulness - General mindfulness
Time Frame: Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments)
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Five-Facet Mindfulness Questionnaire (FFMQ)
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Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments)
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Mindfulness - Non-attachment
Time Frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program))
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Non-Attachment Scale (NAS)
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Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program))
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Mindfulness - Decentering
Time Frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Experiences Questionnaire (EQ)
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Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Mindfulness - Interoceptive awareness
Time Frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Multidimensional assessment of interoceptive awareness (MAIA)
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Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Mindfulness - State mindfulness
Time Frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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State Mindfulness Scale (SMS)
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Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Compassion - Self-compassion
Time Frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Self-Compassion Scale (SCS)
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Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Compassion - Compassion to others
Time Frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Compassion Scale (CS)
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Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Compassion - Empathy
Time Frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Interpersonal Reactivity Index (IRI)
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Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Compassion - State-compassion
Time Frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Self-Compassion Scale-State (SCS_S)
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Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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Psychological well-being - General well-being
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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Pemberton Happiness Index (PHI)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Psychological well-being - Satisfaction with life
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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Satisfaction With Life Scale (SWLS)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Psychological well-being - Optimism
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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Life Orientation Test-Revised (LOT-R)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Psychological distress - feelings of depression, anxiety and stress
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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Depression Anxiety Stress Scales (DASS-21)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Emotional and cognitive control - Rumination
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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Ruminative Response Style (RRS)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Emotional and cognitive control - thought suppression
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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White Bear Suppression Inventory (WBSI)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Emotional and cognitive control - Attentional control
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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Attentional Control Scale (ACS)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Emotional and cognitive control - Emotion regulation
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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Emotion Regulation Questionnaire (ERQ)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Emotional and cognitive control - Emotional States
Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later)
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Emotional State Scale (ESS)
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Pre and post-intervention assessments (baseline and 8 weeks later)
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Collaborators and Investigators
Investigators
- Principal Investigator: Carmelo Vazquez, PhD, School of Psychology (Complutense University)
Publications and helpful links
General Publications
- Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.
- Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, Hayes R, Huijbers M, Ma H, Schweizer S, Segal Z, Speckens A, Teasdale JD, Van Heeringen K, Williams M, Byford S, Byng R, Dalgleish T. Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse: An Individual Patient Data Meta-analysis From Randomized Trials. JAMA Psychiatry. 2016 Jun 1;73(6):565-74. doi: 10.1001/jamapsychiatry.2016.0076.
- Tang YY, Leve LD. A translational neuroscience perspective on mindfulness meditation as a prevention strategy. Transl Behav Med. 2016 Mar;6(1):63-72. doi: 10.1007/s13142-015-0360-x.
- van der Velden AM, Roepstorff A. Neural mechanisms of mindfulness meditation: bridging clinical and neuroscience investigations. Nat Rev Neurosci. 2015 Jul;16(7):439. doi: 10.1038/nrn3916-c1. Epub 2015 Jun 17. No abstract available.
- Malinowski P. Neural mechanisms of attentional control in mindfulness meditation. Front Neurosci. 2013 Feb 4;7:8. doi: 10.3389/fnins.2013.00008. eCollection 2013.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSI-559959-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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