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

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ClinicalTrials.gov Identifier: NCT03035669
Recruitment Status : Unknown
Verified January 2017 by Simon Guendelman, Humboldt-Universität zu Berlin.
Recruitment status was:  Recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Simon Guendelman, Humboldt-Universität zu Berlin

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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Emotional Stress Social Cognition Mindfulness Behavioral: Mindfulness group Behavioral: Reading group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Mindfulness Training on Emotion Regulation and Social Cognition, a Psychophysiological and Neuroimaging Randomized Controled Study.
Study Start Date : November 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: 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.
Behavioral: Mindfulness group
8 week program
Other Name: mindfulness based stress reduction

Active Comparator: 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.
Behavioral: Reading group
8 week program
Other Name: Reading and sharing group




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]

Secondary Outcome Measures :
  1. Changes in resting state functional connectivity between inter-networks connectivity. [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
    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.

  2. 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. [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
  3. Behavioural tasks: mind-wandering task [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
    Changes in mind-wandering task, measured as changes in task-unrelated thoughts.

  4. Changes in personality functioning. [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
    Significant changes in levels of personality functioning measured by the operationalized psychodynamic diagnosis scale.

  5. Experience Sampling of emotional tolerance [ Time Frame: first acquisition period during 3 weeks before the intervention, last acquisition period during 3 weeks after the intervention. And during the intervention period everyday. ]
    Significant changes in self-reported capacity for emotion tolerance.

  6. Changes in psychophysiological measurements of stress (sympathetic component) [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
    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.

  7. Changes in psychophysiological measurements of stress (vagal component) [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
    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.

  8. Behavioural tasks: empathy test. [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
    Changes in empathy test, measured as changes in levels of cognitive and affective empathy.

  9. Changes in self-reported affective states [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
    Significant changes in self-reported levels of negative and positive affects measured by the PANAS scale.

  10. Changes in social functioning [ Time Frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention. ]
    Significant changes in the interpersonal competence questionnaire self-reported scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035669


Contacts
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Contact: Isabel Dziobek, Professor, PhD. (030) 2093-6186 isabel.dziobek@hu-berlin.de
Contact: Simon Guendelman, MD. (030) 2093-6186 simon.guendelman@hu-berlin.de

Locations
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Germany
Berlin School of Mind & Brain, Humboldt Universität. Recruiting
Berlin, Germany, 10117
Contact: Simon Guendelman, MD    (030) 2093-6186    simon.guendelman@hu-berlin.de   
Sponsors and Collaborators
Humboldt-Universität zu Berlin
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
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Study Chair: Isabel Dziobek, Professor, PhD. Humboldt Universität.

Additional Information:
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Responsible Party: Simon Guendelman, Medical doctor, doctorate candidate., Humboldt-Universität zu Berlin
ClinicalTrials.gov Identifier: NCT03035669     History of Changes
Other Study ID Numbers: HumboldtUB
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms