Effects of Mindfulness Training on Emotion Regulation and Social Cognition. (MFN&SOCCOG)

January 25, 2017 updated by: Simon Guendelman, Humboldt-Universität zu Berlin

Effects of Mindfulness Training on Emotion Regulation and Social Cognition, a Psychophysiological and Neuroimaging Randomized Controled Study.

The present study will investigate the effects of a mindfulness training on emotion regulation and social cognition, using several psychological, behavioral, psychophysiological and neuroimaging methods.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the present study is to evaluate the impact of a mindfulness intervention, particularly the mindfulness-based stress reduction (MBSR), on the capacities of emotion regulation and social cognition, in caring/helping professions which are vulnerable to stress. In the context of a longitudinal intervention study, a randomized controlled trial, the efficacy of the MBSR to increase the capacity for self-emotion regulation, empathic attunement, and compassion capacities will be measured. For doing this, several psychological, behavioral, psychophysiological and neuroimaging brain measurements will be used.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Berlin School of Mind & Brain, Humboldt Universität.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers: Men or women
  • Right-handed
  • Normal or corrected-to-normal visión
  • German as a first language
  • No history of neurological or psychiatric problems, or use of controlled medication that might interfere with emotion or attention.
  • No symptoms of claustrophobia
  • Written informed consent form to participate in the study and neuro-imaging experiment.

Exclusion Criteria:

  • Chemical dependence, including nicotine and alcohol
  • Dementia or psychotic condition.
  • Depression or use of antidepressants
  • Pregnant or breast-feeding women
  • Prior MBSR class or regularly practicing mindfulness meditation (or yoga) for three or more months.
  • Non-controlled severe medical disease that might interfere with the performance of the study, such as neoplasias, cardiopathies, digestive pathologies, diabetes mellitus type I or type II
  • Neoplasias in the central nervous system
  • Tremor or dystonia in cephalic segment that hinders the performance of the MRI study (tremor equal to or higher than 3 in each corporal segment, according to the UPDRS scale)
  • Fulfillment of any criterion of contraindication for the MRI exam (for instance, metallic implants, claustrophobia, pregnancy, use of pacemaker; intracranial aneurism clip; cochlear implants).
  • Presence of odontological devices that might disturb the magnetic field or any sources of variation of the magnetic susceptibility
  • Any other conditions the investigator might deem problematic for the inclusion of the volunteer in a trial of this nature will also be considered.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness group
Mindfulness based stress reduction: 8 week program, including meditation, body-awareness, and yoga practices. Daily assignments and home practices during 50 minutes per day.
Behavioral: Mindfulness group
8 week program
Other Names:
  • mindfulness based stress reduction
Active Comparator: Reading group
Reading and sharing group: 8 week program, including readings, interpersonal exchanges, group discussion, listening and role playing exercises. Daily assignments and home practices during 50 minutes per day.
Behavioral: Reading group
8 week program
Other Names:
  • Reading and sharing group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Activation changes in emotions related brain regions. Measured by significant changes in the BOLD (blood oxygenated level dependent) signal from task based functional magnetic resonance imaging.
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in resting state functional connectivity within brain networks. Measured by significant changes in intrinsic functional connectivity parameters, estimated from the resting state BOLD signal, during functional magnetic resonance imaging.
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in resting state functional connectivity between inter-networks connectivity.
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes between brain networks connectivity (including DMN, fronto-parietal and salience networks), measured as significant changes in inter-networks connectivity parameters estimated from the temporal correlation of intrinsic functional connectivity networks.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in regional brain morphometry in stress processing related areas. Measured by significant changes in regional grey matter density estimated from structural magnetic resonance imaging.
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Behavioural tasks: mind-wandering task
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in mind-wandering task, measured as changes in task-unrelated thoughts.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in personality functioning.
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Significant changes in levels of personality functioning measured by the operationalized psychodynamic diagnosis scale.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Experience Sampling of emotional tolerance
Time Frame: first acquisition period during 3 weeks before the intervention, last acquisition period during 3 weeks after the intervention. And during the intervention period everyday.
Significant changes in self-reported capacity for emotion tolerance.
first acquisition period during 3 weeks before the intervention, last acquisition period during 3 weeks after the intervention. And during the intervention period everyday.
Changes in psychophysiological measurements of stress (sympathetic component)
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Activation changes in psychophysiological stress parameters using Skin Conductance Response (measured as significant changes in tonic and phasic response levels) during an emotion regulation task.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in psychophysiological measurements of stress (vagal component)
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Activation changes in psychophysiological stress parameters using Heart Rate Variability (power analysis of high frequency sub-bands of heart rate spectrum), during an emotion regulation task.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Behavioural tasks: empathy test.
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in empathy test, measured as changes in levels of cognitive and affective empathy.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in self-reported affective states
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Significant changes in self-reported levels of negative and positive affects measured by the PANAS scale.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in social functioning
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Significant changes in the interpersonal competence questionnaire self-reported scale.
first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Humboldt-Universität zu Berlin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Comisión Nacional de Investigación Científica y Tecnológica

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Isabel Dziobek, Professor, PhD., Humboldt Universität.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HumboldtUB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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