Effects of mindfulness meditation on brain structure and function

ISRCTN	ISRCTN95197731
DOI	https://doi.org/10.1186/ISRCTN95197731

Submission date: 14/02/2022
Registration date: 15/02/2022
Last edited: 06/03/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Mindfulness describes the ability to consciously engage in a state of non-judgemental, present moment attendance. Mindfulness can be trained through the practice of mindfulness meditation. Research has demonstrated that mindfulness meditation has beneficial effects on health and cognition. However, the underlying neural mechanisms are not yet fully understood. This study aims to extend knowledge on these mechanisms. This can help to improve applications of mindfulness meditation in clinical and non-clinical settings.

Who can participate?
Healthy adults between 18 and 65 with little or no meditation experience

What does the study involve?
Participants are recruited from the general public via public advertisement and are assigned to either 31 days of mindfulness meditation training or an active control condition. In the mindfulness meditation, training an experienced mindfulness meditation instructor provides information on mindfulness meditation and guided meditation sessions. In the active control condition, information on various topics of general health is provided. Training sessions are in video or audio format. Both training programs can be accessed via an online platform and are delivered in training sessions of 15 minutes. Before and after the intervention, participants undergo (functional) magnetic resonance imaging (MRI). Participants also complete questionnaires on various aspects of psychological wellbeing.

What are the possible benefits and risks of participating?
Possible benefits of the experimental treatment include positive side-effects of meditation, such as reduction of stress levels and improvement of cognitive functions. Participants of the control condition may profit by gaining knowledge about health and health-related behaviour. The risks of participating are generally low and include intolerance of the MRI measure.

Where is the study run from?
The study is being run from the Technical University of Munich and takes place in the Klinikum Rechts der Isar, Munich (Germany)

When is the study starting and how long is it expected to run for?
June 2017 to October 2018

Who is funding the study?
Fundraising is conducted by one of the study's investigators (Britta Hölzel) and includes contributions from individual donators wanting to support mindfulness research

Who is the main contact?
1. Benno Bremer
benno.bremert@tum.de
2. Kathrin Koch
kathrin.koch@tum.de
3. Britta Hölzel
britta.hoelzel@tum.de
4. María Mora Álvarez
maria.mora@tum.de

Contact information

Mr Benno Bremer
Scientific

Ismaninger Str. 22
Munich
81675
Germany

ORCID ID	0000-0002-3066-8998
Phone	+49 1719549738
Email	benno.bremer@tum.de

Prof Kathrin Koch
Principal Investigator

Ismaninger Str. 22
Munich
81675
Germany

ORCID ID	0000-0003-4664-8016
Phone	+49 8941407972
Email	kathrin.koch@tum.de

Ms María Mora Álvarez
Scientific

Ismaninger Str. 22
Munich
81675
Germany

ORCID ID	0000-0002-0578-2000
Phone	+49 8941407972
Email	maria.mora@tum.de

Dr Britta Hölzel
Principal Investigator

Ismaninger Str. 22
Munich
81675
Germany

Phone	+49 8941407972
Email	britta.hoelzel@tum.de

Study information

Study design	Monocentric interventional single-blinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Effects of a 31-days web-based mindfulness training on brain structure, cognitive performance, brain activation and functional connectivity
Study objectives	Mindfulness meditation increases attentional performance, increases activation of attention-related areas of the brain and alters functional connectivity
Ethics approval(s)	Approved 08/08/2017, Ethics committe of Technische Universität München (Ismaninger Straße 22, 81675 München, +49 89 4140-7737, ethikkommission@mri.tum.de); ref: 284/17 S
Health condition(s) or problem(s) studied	Effects of mindfulness meditation on brain structure and function in healthy adults
Intervention	Participants are pseudo-randomly assigned to either a mindfulness meditation training or a strictly informative control intervention containing information on various topics of general health. Both training programs are web-based and delivered in portions of 15 minutes over the course of 31 days.
Intervention type	Behavioural
Primary outcome measure	1. Cognitive performance is measured using various parameters of attentional performance before and after the intervention. 2. Structural changes are measured using MRI before and after the intervention. 3. Brain activation and functional connectivity are measured using fMRI before and after the intervention.
Secondary outcome measures	1. Psychological wellbeing is measured using questionnaires on various parameters of psychological wellbeing before and after the intervention.
Overall study start date	01/06/2017
Completion date	28/10/2019

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	60
Total final enrolment	58
Key inclusion criteria	1. Age range 18-65 years 2. MRI suitability 3. Ability to provide consent 4. Written informed consent 5. Right-handedness
Key exclusion criteria	1. Presence of psychiatric or neurologic conditions 2. Meditation experience of more than three meditations within the past year or more than ten meditations within the entire life span 3. Use of psychotropic drugs 4. Pregnancy
Date of first enrolment	27/08/2018
Date of final enrolment	28/09/2019

Locations

Countries of recruitment

Germany

Study participating centre

Klinikum Rechts der Isar, Technical University of Munich

Ismaninger Str. 22
Munich
81675
Germany

Sponsor information

Technical University of Munich
University/education

Ismaninger Str. 22
Munich
81675
Germany

Phone	+49 89 28901
Email	info@tum.de
Website	https://www.tum.de/
"ROR"	https://ror.org/02kkvpp62

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/12/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	Data have been made publicly available via the Open Science Framework at https://doi.org/10.17605/osf.io/rz3hs

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Dataset		23/09/2021	29/06/2022	No	No
Results article	Primary outcome results article	02/08/2022	03/08/2022	Yes	No
Protocol file			10/10/2022	No	No
Results article		19/12/2023	06/03/2024	Yes	No

Additional files

ISRCTN95197731_Protocol.pdf

Editorial Notes

06/03/2024: Publication reference added.
10/10/2022: Protocol file uploaded.
03/08/2022: Publication reference added.
29/06/2022: IPD sharing statement added.
28/06/2022: The intention to publish date was changed from 01/08/2022 to 01/12/2022.
20/06/2022: The intention to publish date was changed from 01/06/2022 to 01/08/2022.
15/02/2022: Trial's existence confirmed by Technische Universität München.