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Cognition and Emotion in Meditation: A Comparison Between Mindfulness and Compassion Standardized Programs

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ClinicalTrials.gov Identifier: NCT03920241
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Carmelo Vázquez, Universidad Complutense de Madrid

Tracking Information
First Submitted Date March 12, 2019
First Posted Date April 18, 2019
Last Update Posted Date April 18, 2019
Actual Study Start Date May 1, 2017
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2019)
  • Change from Baseline in attention performance (Lab measures) [ Time Frame: Pre- and post-intervention assessments (baseline and 8 weeks later) ]
    Attentional blink (accuracy emotion identification)
  • Change from Baseline in brain activity (Lab measures) [ Time Frame: Pre- and post-intervention assessments (baseline and 8 weeks later) ]
    EEG (frontal lobe activity)
  • Change from Baseline in heart activity (Lab measures) [ Time Frame: Pre- and post-intervention assessments (baseline and 8 weeks later) ]
    EKG (Heart rate variability)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 17, 2019)
  • Mindfulness - General mindfulness [ Time Frame: Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments) ]
    Five-Facet Mindfulness Questionnaire (FFMQ)
  • 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)) ]
    Non-Attachment Scale (NAS)
  • 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) ]
    Experiences Questionnaire (EQ)
  • 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) ]
    Multidimensional assessment of interoceptive awareness (MAIA)
  • 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) ]
    State Mindfulness Scale (SMS)
  • 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) ]
    Self-Compassion Scale (SCS)
  • 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) ]
    Compassion Scale (CS)
  • 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) ]
    Interpersonal Reactivity Index (IRI)
  • 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) ]
    Self-Compassion Scale-State (SCS_S)
  • Psychological well-being - General well-being [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Pemberton Happiness Index (PHI)
  • Psychological well-being - Satisfaction with life [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Satisfaction With Life Scale (SWLS)
  • Psychological well-being - Optimism [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Life Orientation Test-Revised (LOT-R)
  • Psychological distress - feelings of depression, anxiety and stress [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Depression Anxiety Stress Scales (DASS-21)
  • Emotional and cognitive control - Rumination [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Ruminative Response Style (RRS)
  • Emotional and cognitive control - thought suppression [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    White Bear Suppression Inventory (WBSI)
  • Emotional and cognitive control - Attentional control [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Attentional Control Scale (ACS)
  • Emotional and cognitive control - Emotion regulation [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Emotion Regulation Questionnaire (ERQ)
  • Emotional and cognitive control - Emotional States [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Emotional State Scale (ESS)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cognition and Emotion in Meditation: A Comparison Between Mindfulness and Compassion Standardized Programs
Official Title Changes in Cognitive and Emotional Patterns Associated to Meditation and Compassion Training: Attentional Changes and Network Dynamics
Brief Summary

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.

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 Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy volunteers, from the community, attending courses of mindfulness or compasion at a University center.
Condition
  • Well-being
  • Emotion Regulation
  • Cognitive Control
  • Attention
  • Psychological Distress
  • Psychophysiologic Reaction
  • Compassion
  • Mindfulness
Intervention
  • Behavioral: Mindfulness-Based Stress Reduction

    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 Name: MBSR
  • Behavioral: Compassion Cultivation Training

    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 Name: CCT
  • Other: Control Group
    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.
Study Groups/Cohorts
  • MBSR group
    Attendants to Mindfulness-Based Stres Reduction programs offered to the community by Complutense University
    Intervention: Behavioral: Mindfulness-Based Stress Reduction
  • CCT group
    Attendants to Compassion Cultivation Training programs offered to the community by Complutense University
    Intervention: Behavioral: Compassion Cultivation Training
  • Control group
    Control group matched by age, gender, and meditation experience.
    Intervention: Other: Control Group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2019)
650
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 15, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Carmelo Vazquez, PhD 34645326292 cvazquez@ucm.es
Contact: Pablo Roca, MSc 34686104687 pabloroc@ucm.es
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03920241
Other Study ID Numbers PSI-559959-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Carmelo Vázquez, Universidad Complutense de Madrid
Study Sponsor Universidad Complutense de Madrid
Collaborators Not Provided
Investigators
Principal Investigator: Carmelo Vazquez, PhD School of Psychology (Complutense University)
PRS Account Universidad Complutense de Madrid
Verification Date April 2019