Meditation Based Lifestyle Modification in Healthy Individuals (MBLM-H)

MBLM is a holistic therapy for people with mental disorders whose positive effects on patients with depression have already been demonstrated in clinical use and a pilot study. In the present study, the differential effects of MBLM domains (ethical living, healthy lifestyle, and mantra meditation) on healthy volunteers will be investigated.

Study Overview

• Status: Completed
• Conditions: Mantra Meditation; Mantra Meditation + Body-Oriented Yoga; Mantra Meditation + Ethical Living; Mantra Meditation + Body-Oriented Yoga + Ethical Living
• Intervention / Treatment: Behavioral: Mantra Meditation; Behavioral: Ethical Living; Behavioral: Yoga Exercises

Detailed Description

MBLM expands existing concepts of mind-body medicine with ethical and spiritual concepts from the traditional Patanjali yoga system, which can act as a coping factor on the one hand, and higher motivation and deepening of practice (physical yoga exercises / mantra Meditation). MBLM aims to establish an exercise routine in the daily lives of the participants, which leads to salutogenesis. The promotion of mental health through meditation and yoga has been well documented (Büssing et al., 2012, Sedlmeier, Ebert, & Schwarz, 2012), also in clinical populations (Ospina et al., 2007). The preventive potential of the MBLM program will be examined for healthy volunteers, analogous to the already well-researched and widely used Mindfulness Based Stress Reduction program.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Sachsen
    • Colditz, Sachsen, Germany, 04680
      • Diakoniekliniken Zschadraß

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• signed informed consent

Exclusion Criteria:

1. Psychiatric disorder
2. Current participation in another meditation or yoga study
3. Regular existing meditation or yoga practice (more than once a week in the last 6 months)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mantra Meditation; 8 weeks of mantra meditation with weekly group sessions.	Behavioral: Mantra Meditation; Meditation with mantras
Experimental: Mantra Meditation plus Ethical Practice; 8 weeks of mantra meditation plus ethical practice with weekly group sessions.	Behavioral: Mantra Meditation; Meditation with mantras; Behavioral: Ethical Living; Ethical principles based on Yoga philosophy, including contents of Yamas and Niyamas.
Experimental: Mantra Meditation plus Yoga Exercises; 8 weeks of mantra meditation plus Yoga Exercises with weekly group sessions.	Behavioral: Mantra Meditation; Meditation with mantras; Behavioral: Yoga Exercises; Ujjaii breathing and simple yoga asanas
Experimental: Mantra Meditation plus Yoga Exercises plus Ethical Practice; 8 weeks of mantra meditation plus Yoga Exercises plus ethical practice with weekly group sessions.	Behavioral: Mantra Meditation; Meditation with mantras; Behavioral: Ethical Living; Ethical principles based on Yoga philosophy, including contents of Yamas and Niyamas.; Behavioral: Yoga Exercises; Ujjaii breathing and simple yoga asanas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Well-Being	WHO (Five) Well-Being Index (WHO-5)	Change from baseline Well-Being at 8 Weeks
Change of Mind-Wandering	Mind Wandering Questionnaire	Change from baseline Mind-Wandering at 8 Weeks
Change of Emotion regulation	Difficulties in Emotion Regulation Scale (DERS)	Change from baseline Emotion Regulation at 8 Weeks
Change of Perceived Stress	Perceived Stress Scale (PSS)	Change from baseline Stress at 8 Weeks
Change of Attention	Sustained Attention to Response Task	Change from baseline Attention at 8 Weeks
Change of Body Awareness	Body Awareness Questionnaire	Change from baseline body awareness at 8 Weeks
Life Satisfaction	Satisfaction with Life Scale	Change from baseline life satisfaction at 8 Weeks
Course satisfaction	Client Satisfaction Questionnaire	After 8 weeks of intervention
Adverse Events	70 possible adverse events or extraordinary experiences associated with meditation or yoga practice.	After 8 weeks of intervention

Collaborators and Investigators

• Sponsor: Diakonie Kliniken Zschadraß
• Collaborators: Chemnitz University of Technology

Publications and helpful links

General Publications

• Matko K, Sedlmeier P, Bringmann HC. Differential Effects of Ethical Education, Physical Hatha Yoga, and Mantra Meditation on Well-Being and Stress in Healthy Participants-An Experimental Single-Case Study. Front Psychol. 2021 Aug 5;12:672301. doi: 10.3389/fpsyg.2021.672301. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MBLM-H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All data will be made available for free online access.
• IPD Sharing Time Frame: 2021
• IPD Sharing Supporting Information Type: Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No