Meditation Based Lifestyle Modification in Healthy Individuals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Meditation Based Lifestyle Modification in Healthy Individuals

Conditions
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Mantra Meditation, Mantra Meditation + Body-Oriented Yoga, Mantra Meditation + Ethical Living, Mantra Meditation + Body-Oriented Yoga + Ethical Living

Intervention / Treatment
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* Behavioral: Ethical Living
* Behavioral: Yoga Exercises
* Behavioral: Mantra Meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent Exclusion Criteria: Psychiatric disorder Current participation in another meditation or yoga study Regular existing meditation or yoga practice (more than once a week in the last 6 months)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 Treatment Conditions: Multiple-baseline design: 3 Baselines (7, 14, 21 days)
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |