Effects of Mindfulness Training on Emotion Regulation and Social Cognition.

NCT ID: NCT03035669

Last Updated: 2017-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Stress, Psychological Emotional Stress Social Cognition Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness group

Intervention Type BEHAVIORAL

8 week program

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.

Group Type ACTIVE_COMPARATOR

Reading group

Intervention Type BEHAVIORAL

8 week program

Interventions

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Mindfulness group

8 week program

Intervention Type BEHAVIORAL

Reading group

8 week program

Intervention Type BEHAVIORAL

Other Intervention Names

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mindfulness based stress reduction Reading and sharing group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

Sponsor Role collaborator

Humboldt-Universität zu Berlin

OTHER

Sponsor Role lead

Responsible Party

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Simon Guendelman

Medical doctor, doctorate candidate.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabel Dziobek, Professor, PhD.

Role: STUDY_CHAIR

Humboldt Universität.

Locations

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Berlin School of Mind & Brain, Humboldt Universität.

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Isabel Dziobek, Professor, PhD.

Role: CONTACT

(030) 2093-6186

Simon Guendelman, MD.

Role: CONTACT

(030) 2093-6186

Facility Contacts

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Simon Guendelman, MD

Role: primary

(030) 2093-6186

References

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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.

Reference Type DERIVED
PMID: 35259523 (View on PubMed)

Related Links

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Other Identifiers

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HumboldtUB

Identifier Type: -

Identifier Source: org_study_id

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