Effects of Mindfulness Training on Emotion Regulation and Social Cognition.

NCT03035669 | Unknown

• 1 other identifier: HumboldtUB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Emotional Stress; Social Cognition; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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 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

  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.

• 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.

Study Arms (2)

Mindfulness group

EXPERIMENTAL

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

Reading group

ACTIVE COMPARATOR

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

Interventions

Mindfulness group BEHAVIORAL

8 week program

Also known as: mindfulness based stress reduction

Mindfulness group

Reading group BEHAVIORAL

8 week program

Also known as: Reading and sharing group

Reading group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Humboldt-Universität zu Berlin: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Berlin School of Mind & Brain, Humboldt Universität.

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 35259523 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Isabel Dziobek, Professor, PhD.

  Humboldt Universität.

  STUDY CHAIR

Central Study Contacts

Isabel Dziobek, Professor, PhD.

CONTACT

(030) 2093-6186; isabel.dziobek@hu-berlin.de

Simon Guendelman, MD.

CONTACT

(030) 2093-6186; simon.guendelman@hu-berlin.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, doctorate candidate.

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: January 30, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 30, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)