NCT03920241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2.6 years

First QC Date

March 12, 2019

Last Update Submit

May 20, 2022

Conditions

Keywords

MindfulnessCompassionWell-beingNetwork analysisMBSRCCTAttentional blinkCognition

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in attention performance (Lab measures)

    Attentional blink (accuracy emotion identification)

    Pre- and post-intervention assessments (baseline and 8 weeks later)

  • Change from Baseline in brain activity (Lab measures)

    EEG (frontal lobe activity)

    Pre- and post-intervention assessments (baseline and 8 weeks later)

  • Change from Baseline in heart activity (Lab measures)

    EKG (Heart rate variability)

    Pre- and post-intervention assessments (baseline and 8 weeks later)

Secondary Outcomes (18)

  • Mindfulness - General mindfulness

    Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments)

  • Mindfulness - Non-attachment

    Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program))

  • Mindfulness - Decentering

    Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)

  • Mindfulness - Interoceptive awareness

    Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)

  • Mindfulness - State mindfulness

    Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)

  • +13 more secondary outcomes

Study Arms (3)

MBSR group

Attendants to Mindfulness-Based Stres Reduction programs offered to the community by Complutense University

Behavioral: Mindfulness-Based Stress Reduction

CCT group

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

Behavioral: Compassion Cultivation Training

Control group

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

Other: Control Group

Interventions

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/).

Also known as: MBSR
MBSR group

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/).

Also known as: CCT
CCT 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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers, from the community, attending courses of mindfulness or compasion at a University center.

You may qualify if:

  • years of age or more
  • Fluency in oral and written Spanish

You may not qualify if:

  • Having any current of serious psychological disorder or substance abuse / dependence.
  • Being currently enrolled in another standardized meditation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology

Madrid, 28223, Spain

Location

Related Publications (5)

  • 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.

    PMID: 25818837BACKGROUND
  • 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.

    PMID: 27012254BACKGROUND
  • 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.

    PMID: 26081785BACKGROUND
  • 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.

    PMID: 27119968BACKGROUND
  • 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.

MeSH Terms

Conditions

Emotional Regulation

Interventions

Mindfulness-Based Stress ReductionControl Groups

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Carmelo Vazquez, PhD

    School of Psychology (Complutense University)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Psychopathology

Study Record Dates

First Submitted

March 12, 2019

First Posted

April 18, 2019

Study Start

May 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 15, 2020

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations