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Effects of Mindfulness Training on Emotion Regulation and Social Cognition.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03035669
Acronym
MFN&SOCCOG
Enrollment
60
Registered
2017-01-30
Start date
2016-11-30
Completion date
2017-06-30
Last updated
2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Stress, Mindfulness, Social Cognition, Stress, Psychological

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.

Interventions

8 week program

BEHAVIORALReading group

8 week program

Sponsors

Comisión Nacional de Investigación Científica y Tecnológica
CollaboratorOTHER_GOV
Humboldt-Universität zu Berlin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Behavioural tasks: mind-wandering taskfirst 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.
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.
Experience Sampling of emotional tolerancefirst 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.
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.
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 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.
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 social functioningfirst 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 self-reported affective statesfirst 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.
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.

Countries

Germany

Contacts

Primary ContactIsabel Dziobek, Professor, PhD.
isabel.dziobek@hu-berlin.de(030) 2093-6186
Backup ContactSimon Guendelman, MD.
simon.guendelman@hu-berlin.de(030) 2093-6186

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026