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Effect of 8 Weeks of MBSR Training on Neuroplasticity and Improvement of Attention, Memory and Well-Being (MBSR2015)

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ClinicalTrials.gov Identifier: NCT02672761
Recruitment Status : Unknown
Verified May 2017 by Prof. T. Frietsch, MD, MBA, Universitätsmedizin Mannheim.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. T. Frietsch, MD, MBA, Universitätsmedizin Mannheim

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Stress Behavioral: MBSR meditation Behavioral: MBT training Behavioral: Wellness Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MBSR Improves Memory and Attention Due to a Stress Reduction as Opposed to Specific Memory Training
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: MBSR
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.
Behavioral: MBSR meditation
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.

Experimental: MBT
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.
Behavioral: MBT training
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.).

Active Comparator: Wellness
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.
Behavioral: Wellness
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.

Placebo Comparator: Control
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.
Behavioral: Control
The waiting period for the MBSR training to start simply should include no changes in lifestyle, recreational activity or intellectual training




Primary Outcome Measures :
  1. Neuroplasticity [ Time Frame: 8 weeks ]
    dose dependent changes in brain voxel based morphometry in NMR (volume reduction in %)


Secondary Outcome Measures :
  1. well-being [ Time Frame: 8 weeks ]
    dose dependent changes in well-being assessed with a standardized questionnaire (Score)

  2. rumination [ Time Frame: 8 weeks ]
    dose dependent changes in rumination assessed with a standardized questionnaire (score)

  3. MAT [ Time Frame: 8 weeks ]
    dose dependent changes in the computerized memory and attention test MAT (scores)

  4. stress [ Time Frame: 8 weeks ]
    dose dependent changes in individual cortisol levels (micrograms/liter)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • willingness to do MBSR Training
  • Age 25-65 years

Exclusion Criteria:

  • 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

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): NCT02672761


Contacts
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Contact: Thomas Frietsch, MD. PhD, MBA +49 1773344480 frietsch@me.com

Locations
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Germany
Diakonissen Hospital Recruiting
Mannheim, BW, Germany, 69163
Contact: Thomas Frietsch, Prof. MD    +4062181024169    Frietsch@me.com   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
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Study Chair: Thomas Frietsch, MD, PhD, MBA University Medicine Mannheim
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Responsible Party: Prof. T. Frietsch, MD, MBA, Prof. T. Frietsch, PhD, MD, MBA, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02672761    
Other Study ID Numbers: MBSR-Diako-MA-2015
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No