Effects of Mindfulness Training on Emotion Regulation and Social Cognition, a Psychophysiological and Neuroimaging Randomized Controled Study.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Mindfulness group (Behavioral)
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.
Intervention: Reading group (Behavioral)
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Secondary Outcomes
- 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.)
- 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 in personality functioning.(first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.)
- Changes in social functioning(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.)
- 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.)
- Behavioural tasks: mind-wandering task(first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.)
- 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.)
- Behavioural tasks: empathy test.(first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.)
- Changes in self-reported affective states(first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.)
Investigators
Simon Guendelman
Medical doctor, doctorate candidate.
Humboldt-Universität zu Berlin