Effects of Mindfulness Training on Emotion Regulation and Social Cognition.

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.

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

Conditions
-----------------
Stress, Psychological, Emotional Stress, Social Cognition, Mindfulness

Intervention / Treatment
-----------------
* Behavioral: Mindfulness group
* Behavioral: Reading group


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness group<br>Mindfulness based stress reduction: 8 week program, including meditation, body-awareness, and yoga practices. Daily assignments and home practices during 50 minutes per day. | Behavioral: Mindfulness group<br>* 8 week program<br>* Other names: mindfulness based stress reduction;|
| Active Comparator: Reading group<br>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. | Behavioral: Reading group<br>* 8 week program<br>* Other names: Reading and sharing group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |