Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment
Well-being Emotion Regulation Cognitive Control Attention Psychological Distress Psychophysiologic Reaction Compassion Mindfulness Behavioral: Mindfulness-Based Stress Reduction Behavioral: Compassion Cultivation Training Other: Control Group

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Changes in Cognitive and Emotional Patterns Associated to Meditation and Compassion Training: Attentional Changes and Network Dynamics
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 15, 2020

Group/Cohort Intervention/treatment
MBSR group
Attendants to Mindfulness-Based Stres Reduction programs offered to the community by Complutense University
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

CCT group
Attendants to Compassion Cultivation Training programs offered to the community by Complutense University
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

Control group
Control group matched by age, gender, and meditation experience.
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.




Primary Outcome Measures :
  1. 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)

  2. Change from Baseline in brain activity (Lab measures) [ Time Frame: Pre- and post-intervention assessments (baseline and 8 weeks later) ]
    EEG (frontal lobe activity)

  3. Change from Baseline in heart activity (Lab measures) [ Time Frame: Pre- and post-intervention assessments (baseline and 8 weeks later) ]
    EKG (Heart rate variability)


Secondary Outcome Measures :
  1. Mindfulness - General mindfulness [ Time Frame: Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments) ]
    Five-Facet Mindfulness Questionnaire (FFMQ)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. Psychological well-being - General well-being [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Pemberton Happiness Index (PHI)

  11. Psychological well-being - Satisfaction with life [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Satisfaction With Life Scale (SWLS)

  12. Psychological well-being - Optimism [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Life Orientation Test-Revised (LOT-R)

  13. 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)

  14. Emotional and cognitive control - Rumination [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Ruminative Response Style (RRS)

  15. Emotional and cognitive control - thought suppression [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    White Bear Suppression Inventory (WBSI)

  16. Emotional and cognitive control - Attentional control [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Attentional Control Scale (ACS)

  17. Emotional and cognitive control - Emotion regulation [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Emotion Regulation Questionnaire (ERQ)

  18. Emotional and cognitive control - Emotional States [ Time Frame: Pre and post-intervention assessments (baseline and 8 weeks later) ]
    Emotional State Scale (ESS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers, from the community, attending courses of mindfulness or compasion at a University center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920241


Contacts
Layout table for location contacts
Contact: Carmelo Vazquez, PhD 34645326292 cvazquez@ucm.es
Contact: Pablo Roca, MSc 34686104687 pabloroc@ucm.es

Locations
Layout table for location information
Spain
School of Psychology Recruiting
Madrid, Spain, 28223
Contact: Carmelo Vazquez, PhD    34-645326292    cvazquez@ucm.es   
Contact: Pablo Roca, MSc    34-686104687    pabloroc@ucm.es   
Sub-Investigator: Gustavo Diex, MSc         
Sub-Investigator: Nazareth Castellanos, PhD         
Sponsors and Collaborators
Universidad Complutense de Madrid
Investigators
Layout table for investigator information
Principal Investigator: Carmelo Vazquez, PhD School of Psychology (Complutense University)
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Carmelo Vázquez, Full Professor of Psychopathology, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT03920241    
Other Study ID Numbers: PSI-559959-R
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carmelo Vázquez, Universidad Complutense de Madrid:
Mindfulness
Compassion
Well-being
Network analysis
MBSR
CCT
Attentional blink
Cognition