Meditation Based Lifestyle Modification in Healthy Individuals

Mantra Meditation Clinical Trial

— MBLM-H  

Official title:

Meditation Based Lifestyle Modification in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252976
• Other study ID #: MBLM-H
• Status: Completed
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: April 2021
• Source: Diakonie Kliniken Zschadraß
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mantra Meditation
• Mantra Meditation + Body-Oriented Yoga
• Mantra Meditation + Body-Oriented Yoga + Ethical Living
• Mantra Meditation + Ethical Living

Intervention

Behavioral:
• Ethical Living
Ethical principles based on Yoga philosophy, including contents of Yamas and Niyamas.
• Yoga Exercises
Ujjaii breathing and simple yoga asanas
• Mantra Meditation
Meditation with mantras

Locations

Country	Name	City	State
Germany	Diakoniekliniken Zschadraß	Colditz	Sachsen

Sponsors (2)

Lead Sponsor	Collaborator
Diakonie Kliniken Zschadraß	Chemnitz University of Technology

Country where clinical trial is conducted

Germany, 

Outcome

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