Clinical trial NCT02672761: Effect of 8 Weeks of MBSR Training on Neuroplasticity and Improvement of Attention, Memory and Well-Being
Official title: MBSR Improves Memory and Attention Due to a Stress Reduction as Opposed to Specific Memory Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 140
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Neuroplasticity
timeFrame: 8 weeks
Secondary outcomes:
measure: well-being
timeFrame: 8 weeks
measure: rumination
timeFrame: 8 weeks
measure: MAT
timeFrame: 8 weeks
measure: stress
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Diakonissen Hospital
state: BW
Study officials:
affiliation: University Medicine Mannheim
name: Thomas Frietsch, MD, PhD, MBA
role: STUDY_CHAIR
References: