Well-beingNCT03920241
Cognition and Emotion in Meditation: A Comparison Between Mindfulness and Compassion Standardized Programs
An observational study of Well-being and Emotion Regulation, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-being, Emotion Regulation, Cognitive Control
- What is being tested?
- Mindfulness-Based Stress Reduction and Compassion Cultivation Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 650 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to 15 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, from the community, attending courses of mindfulness or compasion at a University center.
Who may be able to join
- 18 years of age or more
- Fluency in oral and written Spanish
Who cannot join
- Having any current of serious psychological disorder or substance abuse / dependence.
- Being currently enrolled in another standardized meditation program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Well-being, Emotion Regulation, Cognitive Control, Attention, Psychological Distress, Psychophysiologic Reaction
- Being tested
- Mindfulness-Based Stress Reduction, Compassion Cultivation Training, Control Group
- Keywords
- Mindfulness, Compassion, Well-being, Network analysis, MBSR, CCT, Attentional blink, Cognition
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
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/).
Compassion Cultivation TrainingBehavioural
Also called CCT
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/).
Control GroupOther
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 group | Role | What they receive |
|---|---|---|
| MBSR group | Attendants to Mindfulness-Based Stres Reduction programs offered to the community by Complutense University Receives: Behavioral: Mindfulness-Based Stress Reduction | |
| CCT group | Attendants to Compassion Cultivation Training programs offered to the community by Complutense University Receives: Behavioral: Compassion Cultivation Training | |
| Control group | Control group matched by age, gender, and meditation experience. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in attention performance (Lab measures)
Attentional blink (accuracy emotion identification)
Measured: Pre- and post-intervention assessments (baseline and 8 weeks later)
Change from Baseline in brain activity (Lab measures)
EEG (frontal lobe activity)
Measured: Pre- and post-intervention assessments (baseline and 8 weeks later)
Change from Baseline in heart activity (Lab measures)
EKG (Heart rate variability)
Measured: Pre- and post-intervention assessments (baseline and 8 weeks later)
Secondary outcomes (18)
Mindfulness - General mindfulness
Five-Facet Mindfulness Questionnaire (FFMQ)
Measured: Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments)
Mindfulness - Non-attachment
Non-Attachment Scale (NAS)
Measured: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program))
Mindfulness - Decentering
Experiences Questionnaire (EQ)
Measured: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
Mindfulness - Interoceptive awareness
Multidimensional assessment of interoceptive awareness (MAIA)
Measured: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
Mindfulness - State mindfulness
State Mindfulness Scale (SMS)
Measured: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
Compassion - Self-compassion
Self-Compassion Scale (SCS)
Measured: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
Compassion - Compassion to others
Compassion Scale (CS)
Measured: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
Compassion - Empathy
Interpersonal Reactivity Index (IRI)
Measured: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
Compassion - State-compassion
Self-Compassion Scale-State (SCS_S)
Measured: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
Psychological well-being - General well-being
Pemberton Happiness Index (PHI)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Psychological well-being - Satisfaction with life
Satisfaction With Life Scale (SWLS)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Psychological well-being - Optimism
Life Orientation Test-Revised (LOT-R)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Psychological distress - feelings of depression, anxiety and stress
Depression Anxiety Stress Scales (DASS-21)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - Rumination
Ruminative Response Style (RRS)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - thought suppression
White Bear Suppression Inventory (WBSI)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - Attentional control
Attentional Control Scale (ACS)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - Emotion regulation
Emotion Regulation Questionnaire (ERQ)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - Emotional States
Emotional State Scale (ESS)
Measured: Pre and post-intervention assessments (baseline and 8 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 May 2017
- Primary completion1 Dec 2019
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Well-beingStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmelo Vázquez, Universidad Complutense de Madrid
- Investigators
- Carmelo Vazquez, PhD, Principal investigator, School of Psychology (Complutense University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920241
- Sponsor's protocol ID
- PSI-559959-R
- Status last verified
- May 2022
- First submitted
- 12 Mar 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25818837Tang 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.
PubMed 27012254van 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.
PubMed 26081785Kuyken 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.
PubMed 27119968Malinowski P. Neural mechanisms of attentional control in mindfulness meditation. Front Neurosci. 2013 Feb 4;7:8. doi: 10.3389/fnins.2013.00008. eCollection 2013.
PubMed 23382709
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cognitive and Emotional Patterns Associated to Meditation and Compassion Training: Attentional Changes and Network Dynamics
- ClinicalTrials.gov ID
- NCT03920241
- Acronym / sponsor ID
- PSI-559959-R
- Conditions
- Well-being, Emotion Regulation, Cognitive Control, Attention, Psychological Distress, Psychophysiologic Reaction
- Keywords
- Mindfulness, Compassion, Well-being, Network analysis, MBSR, CCT, Attentional blink, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBSR group | – | Behavioral: Mindfulness-Based Stress ReductionAttendants to Mindfulness-Based Stres Reduction programs offered to the community by Complutense University |
| CCT group | – | Behavioral: Compassion Cultivation TrainingAttendants to Compassion Cultivation Training programs offered to the community by Complutense University |
| Control group | – | Other: Control GroupControl group matched by age, gender, and meditation experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, from the community, attending courses of mindfulness or compasion at a University center.
Key inclusion criteria (2 listed)
- 18 years of age or more
- Fluency in oral and written Spanish
Key exclusion criteria (2 listed)
- Having any current of serious psychological disorder or substance abuse / dependence.
- Being currently enrolled in another standardized meditation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSRThe 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/). | Behavioural | MBSR group |
| Compassion Cultivation TrainingAlso: CCTThe 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/). | Behavioural | CCT group |
| Control GroupA 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. | Other | Control group |
Primary outcome
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)
18 secondary outcomes
Mindfulness - General mindfulness
Time frame: Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments)
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))
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)
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)
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)
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)
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 - Empathy
Time frame: Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)
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)
Psychological well-being - General well-being
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Psychological well-being - Satisfaction with life
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Psychological well-being - Optimism
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Psychological distress - feelings of depression, anxiety and stress
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - Rumination
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - thought suppression
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - Attentional control
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - Emotion regulation
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Emotional and cognitive control - Emotional States
Time frame: Pre and post-intervention assessments (baseline and 8 weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 25818837Khoury 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.
- Background: PubMed 27012254Tang 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.
- Background: PubMed 26081785van 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.
- Background: PubMed 27119968Kuyken 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.
- Results publication: PubMed 23382709Malinowski P. Neural mechanisms of attentional control in mindfulness meditation. Front Neurosci. 2013 Feb 4;7:8. doi: 10.3389/fnins.2013.00008. eCollection 2013.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelo Vazquez, PhD principal investigator
School of Psychology (Complutense University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Well-being and Emotion Regulation, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in attention performance (Lab measures) (time frame: Pre- and post-intervention assessments (baseline and 8 weeks later)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03920241, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.