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

NCT02672761 | Active Not Recruiting DMC

• 1 other identifier: MBSR-Diako-MA-2015
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• Neuroplasticity

  dose dependent changes in brain voxel based morphometry in NMR (volume reduction in %)

  8 weeks

Secondary Outcomes (4)

• well-being

  8 weeks

• rumination

  8 weeks

• MAT

  8 weeks

• stress

  8 weeks

Study Arms (4)

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.

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.

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.

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.

Behavioral: Control

Interventions

MBSR meditation BEHAVIORAL

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.

MBSR

MBT training BEHAVIORAL

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.).

MBT

Wellness BEHAVIORAL

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.

Wellness

Control BEHAVIORAL

The waiting period for the MBSR training to start simply should include no changes in lifestyle, recreational activity or intellectual training

Control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Diakonissen Hospital

Mannheim, Baden-Wurttemberg, 69163, Germany

Location

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Thomas Frietsch, MD, PhD, MBA

  University Medicine Mannheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. T. Frietsch, PhD, MD, MBA

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: February 3, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)