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Effects of Mindfulness Training on Emotion Regulation and Social Cognition. (MFN&SOCCOG)

H

Humboldt-Universität zu Berlin

Status

Unknown

Conditions

Emotional Stress
Mindfulness
Stress, Psychological
Social Cognition

Treatments

Behavioral: Mindfulness group
Behavioral: Reading group

Study type

Interventional

Funder types

Other

Identifiers

NCT03035669
HumboldtUB

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Mindfulness group
Experimental group
Description:
Mindfulness based stress reduction: 8 week program, including meditation, body-awareness, and yoga practices. Daily assignments and home practices during 50 minutes per day.
Treatment:
Behavioral: Mindfulness group
Reading group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Reading group

Trial contacts and locations

1

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Central trial contact

Isabel Dziobek, Professor, PhD.; Simon Guendelman, MD.

Data sourced from clinicaltrials.gov

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