MBLM-H: Meditation Based Lifestyle Modification in Healthy Individuals

• Sponsor: Diakonie Kliniken Zschadraß (Other)
• Overall Status: Completed
• CT.gov ID: NCT04252976
• Collaborator: Chemnitz University of Technology (Other)
• Enrollment: 57
• Location: 1
• Arms: 4
• Actual Duration (Months): 6.1
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mantra Meditation; Mantra Meditation + Body-Oriented Yoga; Mantra Meditation + Ethical Living; Mantra Meditation + Body-Oriented Yoga + Ethical Living	Behavioral: Ethical Living; Behavioral: Yoga Exercises; Behavioral: Mantra Meditation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 4 Treatment Conditions: Multiple-baseline design: 3 Baselines (7, 14, 21 days)4 Treatment Conditions: Multiple-baseline design: 3 Baselines (7, 14, 21 days)
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Meditation Based Lifestyle Modification in Healthy Individuals
• Actual Study Start Date: Mar 28, 2019
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of Well-Being [Change from baseline Well-Being at 8 Weeks]

   WHO (Five) Well-Being Index (WHO-5)

2. Change of Mind-Wandering [Change from baseline Mind-Wandering at 8 Weeks]

   Mind Wandering Questionnaire

3. Change of Emotion regulation [Change from baseline Emotion Regulation at 8 Weeks]

   Difficulties in Emotion Regulation Scale (DERS)

4. Change of Perceived Stress [Change from baseline Stress at 8 Weeks]

   Perceived Stress Scale (PSS)

5. Change of Attention [Change from baseline Attention at 8 Weeks]

   Sustained Attention to Response Task

6. Change of Body Awareness [Change from baseline body awareness at 8 Weeks]

   Body Awareness Questionnaire

7. Life Satisfaction [Change from baseline life satisfaction at 8 Weeks]

   Satisfaction with Life Scale

8. Course satisfaction [After 8 weeks of intervention]

   Client Satisfaction Questionnaire

9. Adverse Events [After 8 weeks of intervention]

   70 possible adverse events or extraordinary experiences associated with meditation or yoga practice.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diakoniekliniken Zschadraß	Colditz	Sachsen	Germany	04680

Sponsors and Collaborators

• Diakonie Kliniken Zschadraß
• Chemnitz University of Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Holger C. Bringmann, Principal Investigator, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04252976
• Other Study ID Numbers: MBLM-H
• First Posted: Feb 5, 2020
• Last Update Posted: Apr 21, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 21, 2021