Clinical trial NCT03920241: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Well-being
Emotion Regulation
Cognitive Control
Attention
Psychological Distress
Psychophysiologic Reaction
Compassion
Mindfulness
Keywords: Mindfulness
Compassion
Well-being
Network analysis
MBSR
CCT
Attentional blink
Cognition
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers, from the community, attending courses of mindfulness or compasion at a University center.

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.

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

Primary outcomes:
measure: Change from Baseline in attention performance (Lab measures)
timeFrame: Pre- and post-intervention assessments (baseline and 8 weeks later)
measure: Change from Baseline in brain activity (Lab measures)
timeFrame: Pre- and post-intervention assessments (baseline and 8 weeks later)
measure: Change from Baseline in heart activity (Lab measures)
timeFrame: Pre- and post-intervention assessments (baseline and 8 weeks later)
Secondary outcomes:
measure: Mindfulness - General mindfulness
timeFrame: Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments)
measure: Mindfulness - Non-attachment
timeFrame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program))
measure: Mindfulness - Decentering
timeFrame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
measure: Mindfulness - Interoceptive awareness
timeFrame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
measure: Mindfulness - State mindfulness
timeFrame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
measure: Compassion - Self-compassion
timeFrame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
measure: Compassion - Compassion to others
timeFrame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
measure: Compassion - Empathy
timeFrame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
measure: Compassion - State-compassion
timeFrame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
measure: Psychological well-being - General well-being
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
measure: Psychological well-being - Satisfaction with life
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
measure: Psychological well-being - Optimism
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
measure: Psychological distress - feelings of depression, anxiety and stress
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
measure: Emotional and cognitive control - Rumination
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
measure: Emotional and cognitive control - thought suppression
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
measure: Emotional and cognitive control - Attentional control
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
measure: Emotional and cognitive control - Emotion regulation
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
measure: Emotional and cognitive control - Emotional States
timeFrame: Pre and post-intervention assessments (baseline and 8 weeks later)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: School of Psychology
Study officials:
affiliation: School of Psychology (Complutense University)
name: Carmelo Vazquez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.