Effects of Mindfulness Training on Emotion Regulation and Social Cognition.

Not Applicable

• Conditions: Social Cognition; Mindfulness; Stress, Psychological; Emotional Stress
• Interventions: Behavioral: Reading group; Behavioral: Mindfulness group

• Registration Number: NCT03035669
• Lead Sponsor: Humboldt-Universität zu Berlin

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-30
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-25
• Last Update Submitted: 2017-01-25
• Study First Posted: 2017-01-30
• Last Update Posted: 2017-01-30
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reading group	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.
Mindfulness group	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Changes in psychophysiological measurements of stress (vagal component)	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.
Changes in resting state functional connectivity between inter-networks connectivity.	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.
Changes in personality functioning.	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.
Changes in social functioning	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.
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.
Changes in psychophysiological measurements of stress (sympathetic component)	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.
Behavioural tasks: mind-wandering task	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.
Experience Sampling of emotional 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.	Significant changes in self-reported capacity for emotion tolerance.
Behavioural tasks: empathy test.	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.
Changes in self-reported affective states	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.

Trial Locations

Locations (1)

Berlin School of Mind & Brain, Humboldt Universität.; 🇩🇪 Berlin, Germany