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

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: Unknown
• Conditions: Stress, Psychological; Emotional Stress; Mindfulness; Social Cognition
• Intervention / Treatment: Behavioral: Mindfulness group; Behavioral: Reading group

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Berlin School of Mind & Brain, Humboldt Universität.
    • Contact: Simon Guendelman, MD; Phone Number: (030) 2093-6186; Email: simon.guendelman@hu-berlin.de

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.		first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Behavioural tasks: mind-wandering task	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.	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	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)	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)	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.	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	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	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

• Sponsor: Humboldt-Universität zu Berlin
• Collaborators: Comisión Nacional de Investigación Científica y Tecnológica
• Investigators: Study Chair: Isabel Dziobek, Professor, PhD., Humboldt Universität.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: HumboldtUB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO