Stress, Psychological Clinical Trial
— MFN&SOCCOGOfficial title:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteers: Men or women - Right-handed - Normal or corrected-to-normal visiĆ³n - 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Berlin School of Mind & Brain, Humboldt Universität. | Berlin |
Lead Sponsor | Collaborator |
---|---|
Humboldt-Universität zu Berlin | Comisión Nacional de Investigación Científica y Tecnológica |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | ||
Primary | 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 | 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. | |
Secondary | 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. | ||
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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