Clinical trial NCT03035669: Effects of Mindfulness Training on Emotion Regulation and Social Cognition.
Official title: Effects of Mindfulness Training on Emotion Regulation and Social Cognition, a Psychophysiological and Neuroimaging Randomized Controled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Emotional Stress
Social Cognition
Mindfulness
Lead sponsor: Humboldt-Universität zu Berlin
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2017-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: 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.
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: 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.
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Secondary outcomes:
measure: Changes in resting state functional connectivity between inter-networks connectivity.
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: 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.
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Behavioural tasks: mind-wandering task
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Changes in personality functioning.
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Experience Sampling of emotional tolerance
timeFrame: first acquisition period during 3 weeks before the intervention, last acquisition period during 3 weeks after the intervention. And during the intervention period everyday.
measure: Changes in psychophysiological measurements of stress (sympathetic component)
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Changes in psychophysiological measurements of stress (vagal component)
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Behavioural tasks: empathy test.
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Changes in self-reported affective states
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Changes in social functioning
timeFrame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Berlin School of Mind & Brain, Humboldt Universität.
Study officials:
affiliation: Humboldt Universität.
name: Isabel Dziobek, Professor, PhD.
role: STUDY_CHAIR
References:
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.