Stress, PsychologicalMFN&SOCCOGNCT03035669
Effects of Mindfulness Training on Emotion Regulation and Social Cognition.
A study testing Mindfulness group and Reading group in people with Stress, Psychological and Emotional Stress, run by Humboldt-Universität zu Berlin at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Emotional Stress, Social Cognition
- What is being tested?
- Mindfulness group and Reading group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Berlin School of Mind & Brain, Humboldt Universität.
Berlin, State of Berlin, 10117
Simon Guendelman, MD, (030) 2093-6186, simon.guendelman@hu-berlin.de
About this study
Official title: Effects of Mindfulness Training on Emotion Regulation and Social Cognition, a Psychophysiological and Neuroimaging Randomized Controled Study.
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.
Read the 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.
- Conditions
- Stress, Psychological, Emotional Stress, Social Cognition, Mindfulness
- Being tested
- Mindfulness group, Reading group
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness groupBehavioural
Also called mindfulness based stress reduction
8 week program
Reading groupBehavioural
Also called Reading and sharing group
8 week program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Reading group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Behavioural tasks: mind-wandering task
Changes in mind-wandering task, measured as changes in task-unrelated thoughts.
Measured: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in personality functioning.
Significant changes in levels of personality functioning measured by the operationalized psychodynamic diagnosis scale.
Measured: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Experience Sampling of emotional tolerance
Significant changes in self-reported capacity for emotion tolerance.
Measured: first acquisition period during 3 weeks before the intervention, last acquisition period during 3 weeks after the intervention. And during the intervention period everyday.
Changes in psychophysiological measurements of stress (sympathetic component)
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.
Measured: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in psychophysiological measurements of stress (vagal component)
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.
Measured: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Behavioural tasks: empathy test.
Changes in empathy test, measured as changes in levels of cognitive and affective empathy.
Measured: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in self-reported affective states
Significant changes in self-reported levels of negative and positive affects measured by the PANAS scale.
Measured: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in social functioning
Significant changes in the interpersonal competence questionnaire self-reported scale.
Measured: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humboldt-Universität zu Berlin
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Principal investigator, Simon Guendelman, Humboldt-Universität zu Berlin
- Investigators
- Isabel Dziobek, Professor, PhD., Study chair, Humboldt Universität.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035669
- Sponsor's protocol ID
- HumboldtUB
- Acronym
- MFN&SOCCOG
- Status last verified
- Jan 2017
- First submitted
- 30 Nov 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35259523
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Training on Emotion Regulation and Social Cognition, a Psychophysiological and Neuroimaging Randomized Controled Study.
- ClinicalTrials.gov ID
- NCT03035669
- Acronym / sponsor ID
- MFN&SOCCOG / HumboldtUB
- Conditions
- Stress, Psychological, Emotional Stress, Social Cognition, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Humboldt-Universität zu BerlinUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group | Experimental | Behavioral: Mindfulness groupMindfulness based stress reduction: 8 week program, including meditation, body-awareness, and yoga practices. Daily assignments and home practices during 50 minutes per day. |
| Reading group | Active comparator | Behavioral: Reading groupReading 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness groupAlso: mindfulness based stress reduction8 week program | Behavioural | Mindfulness group |
| Reading groupAlso: Reading and sharing group8 week program | Behavioural | Reading group |
Primary outcome
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.
10 secondary outcomes
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 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 personality functioning.
Time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
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.
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.
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.
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 self-reported affective states
Time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Changes in social functioning
Time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 35259523Guendelman 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Dziobek, Professor, PhD. study chair
Humboldt Universität.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness group and Reading group in people with Stress, Psychological and Emotional Stress, run by Humboldt-Universität zu Berlin at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Dziobek, Professor, PhD. ((030) 2093-6186, isabel.dziobek@hu-berlin.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03035669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.