StressMBSR2015NCT02672761
Effect of 8 Weeks of MBSR Training on Neuroplasticity and Improvement of Attention, Memory and Well-Being
A study testing MBSR meditation, MBT training and Wellness in people with Stress, run by Heidelberg University at 1 site in Germany.
Trial summary
Meditation improves attention and memory by reducing of the increased electric brain activity induced by a high stress level. This is associated to neuroplastic changes (volume reduction and/or neuron's density increases) in various brain structures. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- MBSR meditation, MBT training and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to 1 Jun 2026
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willingness to do MBSR Training
- Age 25-65 years
Who cannot join
- history of ongoing or non-apparent psychosis under drug treatment
- drug addiction and intake
- non-willingness to accept the group allocation with the respective treatment
- non-compliance with a weekly trainings effort smaller than 20% of default
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MBSR Improves Memory and Attention Due to a Stress Reduction as Opposed to Specific Memory Training
Meditation improves attention and memory by reducing of the increased electric brain activity induced by a high stress level. This is associated to neuroplastic changes (volume reduction and/or neuron's density increases) in various brain structures. The question evolves if memory improvement by a standardized meditation program of 8 weeks (Mindfulness Based Stress Reduction MBSR) or a specific memory training (My Brain Training MBT) is a specific effect on brain networking or mediated by a reduced general activity induced by stress reduction. Thus, meditation or memory training should have differing neuroplastic effects.
The effects of memory function improvement by the respective training will be measured by MAT, a specific and validated computerized memory and attention test. Brain morphology is investigated by voxel based morphometry NMR before and immediately after an 8 weeks intervention period. Stress levels are measured by cortisol profiles of subjects. Compared were 4 groups- "MBSR" group- MBSR students after completed training, passive "control" group- subjects following an 8 weeks waiting period for the MBSR training without any memory training, active control "MBT" group- subjects on an 8 weeks waiting period for the MBSR training doing an 8 weeks MBT memory training instead, "Wellness" group - doing a structured program using relaxing massage and calming computerized chair ("Brain Light").
The hypothesis of the study is that MBSR improves memory function better than MBT when measured by MAT. Compared to both active and passive controls, MBSR training induces specific morphologic changes in the brain, indicated by a volume change of the voxel based morphometry method of 5% of a defined brain region. In comparison to smaller and less neuroplasticity induced by MBT on memory brain regions, MBSR induces greater volume changes on hippocampus and amygdala and stress reduction than the wellness program.
Read the detailed description
The question evolves if memory improvement by a standardized meditation program of 8 weeks (Mindfulness Based Stress Reduction MBSR) or a specific memory training (My Brain Training MBT) is a specific effect on brain networking or mediated by a reduced general activity induced by stress reduction. The capacity of MBSR to induce dramatic neuroplastic changes such as morphological grey matter changes in the brain, reduced amygdala function and volume as well as electric activity level of the somatosensory cortex should allow for a discrimination and allocation of various memorial subfunctions such as visual/figural and episodic as well as acoustic memory. Although networking effects surely are involved in all memory subfunctions, the main brain target regions for verbal/episodic memory is the hippocampus (memory malfunctions are associated with hippocampal volume reduction and/or neuron losses) whereas those for other subfunctions are not known.
Therefore, morphological MBSR effects of the brain were compared to specific memory training via MBT. In this study, MBSR and MBT memory training are working as competitive effects on memory subfunctions, whereas a wellness massage and relaxing program and a do-not-change-anything group will serve as active and passive controls. The effects of memory function improvement by the respective training will be measured by MAT (Memory and Attention Test), a specific and validated computerized memory and attention test. Brain morphology was investigated by voxel based morphometry NMR before and immediately after an 8 weeks intervention period. Targets for morphometry are hippocampus CA1 region for verbal and episodic memory, the visual or acoustic cortex and the combined hippocampus areas for visual and acoustic memories, the amygdala volume for stress level and the frontotemporal lobe as a combined target of MBSR and memory assessment. Stress levels are measured by cortisol profiles of subjects. Compared were 4 groups- "MBSR" group- MBSR students after completed training, passive "control" group- subjects following an 8 weeks waiting period for the MBSR training without any memory training or wellness program, active control "MBT" group- subjects on an 8 week waiting period for the MBSR training doing an 8 week MBT memory training instead, "Wellness" group - doing a structured program using relaxing massage and calming computerized chair ("Brain Light").
The hypothesis of the study is that MBSR improves memory function better than MBT when measured by MAT. Compared to both active and passive controls, MBSR training induces specific morphologic changes in the brain, indicated by a volume change of the voxel based morphometry method of 5% of a defined brain region. In comparison to smaller and less neuroplasticity induced by MBT on memory brain regions, MBSR induces greater volume changes on hippocampus and amygdala and stress reduction than the wellness progam.
- Conditions
- Stress
- Being tested
- MBSR meditation, MBT training, Wellness, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR meditationBehavioural
Adopted from buddhism for western societies by Jon Kabat-Zinn, MBSR has been described as "a group program that focuses upon the progressive acquisition of mindful awareness, of mindfulness". The MBSR program is an eight-week workshop taught by certified trainers that entails weekly group meetings, homework, and instruction in three formal techniques: sitting mindfulness meditation, body scanning and simple yoga postures. Sitting meditation includes concentration on the breathing while not adhering to the flow of thoughts or emotions as well as the development of empathy and loving kindness for all persons. Body scanning is the first prolonged formal mindfulness technique taught during the first four weeks of the workshop, and entails quietly lying on one's back and focusing one's attention on various regions of the body, starting with the toes and moving up slowly to the top of the head.
MBT trainingBehavioural
A specific memory brain training stimulates by a validated program according to Kawashima from the Industry University Research Project the according areas in the prefrontal lobe for calculation, logical reflection, optic/episodes and memory. The computerized program adopts to the difficulty level of the trainee. Selected were trainings for the categories "working/semantic" and "episodic/optical" memory and "logic/calculation" adjusted to the individual's selection from all categories but various themes (like sports, cars etc.).
WellnessBehavioural
The Brain Light Wellness chair is assessed for the stress reduction in industry and public Enterprises. In a European study 97% of subjects reported a stress reduction, improved well-being, performance and increased vitality, less fatigue and petulance. The chair "3D-Float-plus" system comprises of a massage chair in sitting to lying position, a headset with earphones a lighted glasses for visual and audio Stimulation. One standardized session of 45 min duration was chosen for the study that combined a short massage period with a relaxation trance session.
ControlBehavioural
The waiting period for the MBSR training to start simply should include no changes in lifestyle, recreational activity or intellectual training
| Study group | Role | What they receive |
|---|---|---|
| MBSR | Experimental | Subjects enrol and complete a standardized and licensed meditation program developed by Jon Kabat-Zinn. The program includes a weekly 200 min group session, daily meditation training from 20-40 min and one 4 h retreat within the study period. The individual daily and overall training volume is noted in min. Receives: Behavioral: MBSR meditation |
| MBT | Experimental | Subjects while being on the waiting list for MBSR are allocated to a web-based training program (MBT- My Brain Training) for working, episodic and general memory functions. The individual daily and overall training volume is noted in min. Receives: Behavioral: MBT training |
| Wellness | Active comparator | Subjects while being on the waiting list for MBSR are allocated to a free accessable wellness program including sessions in a computerized chair delivering Shiatzu massage and relaxation music. The individual daily and overall training volume is noted in min. Receives: Behavioral: Wellness |
| Control | Placebo comparator | Subjects while being on the waiting list for MBSR are requested to do no special program for stress reduction or memory improvement. The individual daily and overall training volume of sports or recreational activity is noted in min. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroplasticity
dose dependent changes in brain voxel based morphometry in NMR (volume reduction in %)
Measured: 8 weeks
Secondary outcomes (4)
well-being
dose dependent changes in well-being assessed with a standardized questionnaire (Score)
Measured: 8 weeks
rumination
dose dependent changes in rumination assessed with a standardized questionnaire (score)
Measured: 8 weeks
MAT
dose dependent changes in the computerized memory and attention test MAT (scores)
Measured: 8 weeks
stress
dose dependent changes in individual cortisol levels (micrograms/liter)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Frietsch, Universitätsmedizin Mannheim
- Investigators
- Thomas Frietsch, MD, PhD, MBA, Study chair, University Medicine Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672761
- Sponsor's protocol ID
- MBSR-Diako-MA-2015
- Acronym
- MBSR2015
- Status last verified
- May 2022
- First submitted
- 14 Jan 2016
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MBSR Improves Memory and Attention Due to a Stress Reduction as Opposed to Specific Memory Training
- ClinicalTrials.gov ID
- NCT02672761
- Acronym / sponsor ID
- MBSR2015 / MBSR-Diako-MA-2015
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Feb 2016 (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.
Meditation improves attention and memory by reducing of the increased electric brain activity induced by a high stress level. This is associated to neuroplastic changes (volume reduction and/or neuron's density increases) in various brain structures. The question evolves if memory improvement by a standardized meditation program of 8 weeks (Mindfulness Based Stress Reduction MBSR) or a specific memory training (My Brain Training MBT) is a specific effect on brain networking or mediated by a reduced general activity induced by stress reduction. Thus, meditation or memory training should have differing neuroplastic effects.
The effects of memory function improvement by the respective training will be measured by MAT, a specific and validated computerized memory and attention test. Brain morphology is investigated by voxel based morphometry NMR before and immediately after an 8 weeks intervention period. Stress levels are measured by cortisol profiles of subjects. Compared were 4 groups- "MBSR" group- MBSR students after completed training, passive "control" group- subjects following an 8 weeks waiting period for the MBSR training without any memory training, active control "MBT" group- subjects on an 8 weeks waiting period for the MBSR training doing an 8 weeks MBT memory training instead, "Wellness" group - doing a structured program using relaxing massage and calming computerized chair ("Brain Light").
The hypothesis of the study is that MBSR improves memory function better than MBT when measured by MAT. Compared to both active and passive controls, MBSR training induces specific morphologic changes in the brain, indicated by a volume change of the voxel based morphometry method of 5% of a defined brain region. In comparison to smaller and less neuroplasticity induced by MBT on memory brain regions, MBSR induces greater volume changes on hippocampus and amygdala and stress reduction than the wellness program.
Detailed description
The question evolves if memory improvement by a standardized meditation program of 8 weeks (Mindfulness Based Stress Reduction MBSR) or a specific memory training (My Brain Training MBT) is a specific effect on brain networking or mediated by a reduced general activity induced by stress reduction. The capacity of MBSR to induce dramatic neuroplastic changes such as morphological grey matter changes in the brain, reduced amygdala function and volume as well as electric activity level of the somatosensory cortex should allow for a discrimination and allocation of various memorial subfunctions such as visual/figural and episodic as well as acoustic memory. Although networking effects surely are involved in all memory subfunctions, the main brain target regions for verbal/episodic memory is the hippocampus (memory malfunctions are associated with hippocampal volume reduction and/or neuron losses) whereas those for other subfunctions are not known.
Therefore, morphological MBSR effects of the brain were compared to specific memory training via MBT. In this study, MBSR and MBT memory training are working as competitive effects on memory subfunctions, whereas a wellness massage and relaxing program and a do-not-change-anything group will serve as active and passive controls. The effects of memory function improvement by the respective training will be measured by MAT (Memory and Attention Test), a specific and validated computerized memory and attention test. Brain morphology was investigated by voxel based morphometry NMR before and immediately after an 8 weeks intervention period. Targets for morphometry are hippocampus CA1 region for verbal and episodic memory, the visual or acoustic cortex and the combined hippocampus areas for visual and acoustic memories, the amygdala volume for stress level and the frontotemporal lobe as a combined target of MBSR and memory assessment. Stress levels are measured by cortisol profiles of subjects. Compared were 4 groups- "MBSR" group- MBSR students after completed training, passive "control" group- subjects following an 8 weeks waiting period for the MBSR training without any memory training or wellness program, active control "MBT" group- subjects on an 8 week waiting period for the MBSR training doing an 8 week MBT memory training instead, "Wellness" group - doing a structured program using relaxing massage and calming computerized chair ("Brain Light").
The hypothesis of the study is that MBSR improves memory function better than MBT when measured by MAT. Compared to both active and passive controls, MBSR training induces specific morphologic changes in the brain, indicated by a volume change of the voxel based morphometry method of 5% of a defined brain region. In comparison to smaller and less neuroplasticity induced by MBT on memory brain regions, MBSR induces greater volume changes on hippocampus and amygdala and stress reduction than the wellness progam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: MBSR meditationSubjects enrol and complete a standardized and licensed meditation program developed by Jon Kabat-Zinn. The program includes a weekly 200 min group session, daily meditation training from 20-40 min and one 4 h retreat within the study period. The individual daily and overall training volume is noted in min. |
| MBT | Experimental | Behavioral: MBT trainingSubjects while being on the waiting list for MBSR are allocated to a web-based training program (MBT- My Brain Training) for working, episodic and general memory functions. The individual daily and overall training volume is noted in min. |
| Wellness | Active comparator | Behavioral: WellnessSubjects while being on the waiting list for MBSR are allocated to a free accessable wellness program including sessions in a computerized chair delivering Shiatzu massage and relaxation music. The individual daily and overall training volume is noted in min. |
| Control | Placebo comparator | Behavioral: ControlSubjects while being on the waiting list for MBSR are requested to do no special program for stress reduction or memory improvement. The individual daily and overall training volume of sports or recreational activity is noted in min. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- willingness to do MBSR Training
- Age 25-65 years
Key exclusion criteria (4 listed)
- history of ongoing or non-apparent psychosis under drug treatment
- drug addiction and intake
- non-willingness to accept the group allocation with the respective treatment
- non-compliance with a weekly trainings effort smaller than 20% of default
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 |
|---|---|---|
| MBSR meditationAdopted from buddhism for western societies by Jon Kabat-Zinn, MBSR has been described as "a group program that focuses upon the progressive acquisition of mindful awareness, of mindfulness". The MBSR program is an eight-week workshop taught by certified trainers that entails weekly group meetings, homework, and instruction in three formal techniques: sitting mindfulness meditation, body scanning and simple yoga postures. Sitting meditation includes concentration on the breathing while not adhering to the flow of thoughts or emotions as well as the development of empathy and loving kindness for all persons. Body scanning is the first prolonged formal mindfulness technique taught during the first four weeks of the workshop, and entails quietly lying on one's back and focusing one's attention on various regions of the body, starting with the toes and moving up slowly to the top of the head. | Behavioural | MBSR |
| MBT trainingA specific memory brain training stimulates by a validated program according to Kawashima from the Industry University Research Project the according areas in the prefrontal lobe for calculation, logical reflection, optic/episodes and memory. The computerized program adopts to the difficulty level of the trainee. Selected were trainings for the categories "working/semantic" and "episodic/optical" memory and "logic/calculation" adjusted to the individual's selection from all categories but various themes (like sports, cars etc.). | Behavioural | MBT |
| WellnessThe Brain Light Wellness chair is assessed for the stress reduction in industry and public Enterprises. In a European study 97% of subjects reported a stress reduction, improved well-being, performance and increased vitality, less fatigue and petulance. The chair "3D-Float-plus" system comprises of a massage chair in sitting to lying position, a headset with earphones a lighted glasses for visual and audio Stimulation. One standardized session of 45 min duration was chosen for the study that combined a short massage period with a relaxation trance session. | Behavioural | Wellness |
| ControlThe waiting period for the MBSR training to start simply should include no changes in lifestyle, recreational activity or intellectual training | Behavioural | Control |
Primary outcome
Neuroplasticity
Time frame: 8 weeks
dose dependent changes in brain voxel based morphometry in NMR (volume reduction in %)
4 secondary outcomes
well-being
Time frame: 8 weeks
rumination
Time frame: 8 weeks
MAT
Time frame: 8 weeks
stress
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- 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.
Thomas Frietsch, MD, PhD, MBA study chair
University Medicine Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR meditation, MBT training and Wellness in people with Stress, run by Heidelberg University 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 2 inclusion and 4 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 24 May 2022. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroplasticity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022.