Back to results

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

Primary Purpose

Stress, Psychological, Emotional Stress, Social Cognition

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Mindfulness group

Reading group

About this trial

This is an interventional basic science trial for Stress, Psychological

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Berlin School of Mind & Brain, Humboldt Universität.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness group

Reading group

Arm Description

Mindfulness based stress reduction: 8 week program, including meditation, body-awareness, and yoga practices. Daily assignments and home practices during 50 minutes per day.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Changes in resting state functional connectivity between inter-networks connectivity.

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.

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.

Behavioural tasks: mind-wandering task

Changes in mind-wandering task, measured as changes in task-unrelated thoughts.

Changes in personality functioning.

Significant changes in levels of personality functioning measured by the operationalized psychodynamic diagnosis scale.

Experience Sampling of emotional tolerance

Significant changes in self-reported capacity for emotion tolerance.

Changes in psychophysiological measurements of stress (sympathetic component)

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.

Changes in psychophysiological measurements of stress (vagal component)

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.

Behavioural tasks: empathy test.

Changes in empathy test, measured as changes in levels of cognitive and affective empathy.

Changes in self-reported affective states

Significant changes in self-reported levels of negative and positive affects measured by the PANAS scale.

Changes in social functioning

Significant changes in the interpersonal competence questionnaire self-reported scale.

Full Information

NCT ID

NCT03035669

First Posted

November 30, 2016

Last Updated

January 25, 2017

Sponsor

Humboldt-Universität zu Berlin

Collaborators

Comisión Nacional de Investigación Científica y Tecnológica

1. Study Identification

Unique Protocol Identification Number

NCT03035669

Brief Title

Effects of Mindfulness Training on Emotion Regulation and Social Cognition.

Acronym

MFN&SOCCOG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Humboldt-Universität zu Berlin

Collaborators

Comisión Nacional de Investigación Científica y Tecnológica

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress, Psychological, Emotional Stress, Social Cognition, Mindfulness

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness group

Arm Type

Experimental

Arm Description

Mindfulness based stress reduction: 8 week program, including meditation, body-awareness, and yoga practices. Daily assignments and home practices during 50 minutes per day.

Arm Title

Reading group

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness group

Other Intervention Name(s)

mindfulness based stress reduction

Intervention Description

8 week program

Intervention Type

Behavioral

Intervention Name(s)

Reading group

Other Intervention Name(s)

Reading and sharing group

Intervention Description

8 week program

Primary Outcome Measure Information:

Title

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.

Title

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Secondary Outcome Measure Information:

Title

Changes in resting state functional connectivity between inter-networks connectivity.

Description

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Title

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.

Title

Behavioural tasks: mind-wandering task

Description

Changes in mind-wandering task, measured as changes in task-unrelated thoughts.

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Title

Changes in personality functioning.

Description

Significant changes in levels of personality functioning measured by the operationalized psychodynamic diagnosis scale.

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Title

Experience Sampling of emotional tolerance

Description

Significant changes in self-reported capacity for emotion 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.

Title

Changes in psychophysiological measurements of stress (sympathetic component)

Description

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.

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Title

Changes in psychophysiological measurements of stress (vagal component)

Description

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.

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Title

Behavioural tasks: empathy test.

Description

Changes in empathy test, measured as changes in levels of cognitive and affective empathy.

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Title

Changes in self-reported affective states

Description

Significant changes in self-reported levels of negative and positive affects measured by the PANAS scale.

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

Title

Changes in social functioning

Description

Significant changes in the interpersonal competence questionnaire self-reported scale.

Time Frame

first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Isabel Dziobek, Professor, PhD.

Phone

(030) 2093-6186

isabel.dziobek@hu-berlin.de

First Name & Middle Initial & Last Name or Official Title & Degree

Simon Guendelman, MD.

Phone

(030) 2093-6186

simon.guendelman@hu-berlin.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabel Dziobek, Professor, PhD.

Organizational Affiliation

Humboldt Universität.

Official's Role

Study Chair

Facility Information:

Facility Name

Berlin School of Mind & Brain, Humboldt Universität.

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Simon Guendelman, MD

Phone

(030) 2093-6186

simon.guendelman@hu-berlin.de

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35259523

Citation

Guendelman S, Bayer M, Prehn K, Dziobek I. Towards a mechanistic understanding of mindfulness-based stress reduction (MBSR) using an RCT neuroimaging approach: Effects on regulating own stress in social and non-social situations. Neuroimage. 2022 Jul 1;254:119059. doi: 10.1016/j.neuroimage.2022.119059. Epub 2022 Mar 5.

Results Reference

derived

Links:

URL

http://www.mabstudy.de

Description

Related Info

Learn more about this trial

Effects of Mindfulness Training on Emotion Regulation and Social Cognition.

We'll reach out to this number within 24 hrs