Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 30, 2016
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date January 30, 2017
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • 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.
  • 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. ]
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Mindfulness Training on Emotion Regulation and Social Cognition.
Official Title  ICMJE Effects of Mindfulness Training on Emotion Regulation and Social Cognition, a Psychophysiological and Neuroimaging Randomized Controled Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Stress, Psychological
  • Emotional Stress
  • Social Cognition
  • Mindfulness
Intervention  ICMJE
  • Behavioral: Mindfulness group
    8 week program
    Other Name: mindfulness based stress reduction
  • Behavioral: Reading group
    8 week program
    Other Name: Reading and sharing group
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mindfulness group
  • 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.
    Intervention: Behavioral: Reading group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035669
Other Study ID Numbers  ICMJE HumboldtUB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Simon Guendelman, Humboldt-Universität zu Berlin
Study Sponsor  ICMJE Humboldt-Universität zu Berlin
Collaborators  ICMJE Comisión Nacional de Investigación Científica y Tecnológica
Investigators  ICMJE
Study Chair: Isabel Dziobek, Professor, PhD. Humboldt Universität.
PRS Account Humboldt-Universität zu Berlin
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP