NCT04252976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

January 30, 2020

Last Update Submit

April 20, 2021

Conditions

Mantra MeditationMantra Meditation + Body-Oriented YogaMantra Meditation + Ethical LivingMantra Meditation + Body-Oriented Yoga + Ethical Living

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (4)

Mantra Meditation

EXPERIMENTAL

8 weeks of mantra meditation with weekly group sessions.

Behavioral: Mantra Meditation

Mantra Meditation plus Ethical Practice

EXPERIMENTAL

8 weeks of mantra meditation plus ethical practice with weekly group sessions.

Behavioral: Ethical LivingBehavioral: Mantra Meditation

Mantra Meditation plus Yoga Exercises

EXPERIMENTAL

8 weeks of mantra meditation plus Yoga Exercises with weekly group sessions.

Behavioral: Yoga ExercisesBehavioral: Mantra Meditation

Mantra Meditation plus Yoga Exercises plus Ethical Practice

EXPERIMENTAL

8 weeks of mantra meditation plus Yoga Exercises plus ethical practice with weekly group sessions.

Behavioral: Ethical LivingBehavioral: Yoga ExercisesBehavioral: Mantra Meditation

Interventions

Ethical LivingBEHAVIORAL

Ethical principles based on Yoga philosophy, including contents of Yamas and Niyamas.

Mantra Meditation plus Ethical PracticeMantra Meditation plus Yoga Exercises plus Ethical Practice
Yoga ExercisesBEHAVIORAL

Ujjaii breathing and simple yoga asanas

Mantra Meditation plus Yoga ExercisesMantra Meditation plus Yoga Exercises plus Ethical Practice
Mantra MeditationBEHAVIORAL

Meditation with mantras

Mantra MeditationMantra Meditation plus Ethical PracticeMantra Meditation plus Yoga ExercisesMantra Meditation plus Yoga Exercises plus Ethical Practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakoniekliniken Zschadraß

Colditz, Saxony, 04680, Germany

Location

Related Publications (1)

  • 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.

    PMID: 34421729DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: * 4 Treatment Conditions: * Multiple-baseline design: 3 Baselines (7, 14, 21 days)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

March 28, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

April 21, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

All data will be made available for free online access.

Shared Documents
ANALYTIC CODE
Time Frame
2021

Locations

DE(1)