Mantra MeditationMBLM-HNCT04252976
Meditation Based Lifestyle Modification in Healthy Individuals
A study testing Ethical Living, Yoga Exercises and Mantra Meditation in people with Mantra Meditation and Mantra Meditation + Body-Oriented Yoga, run by Diakonie Kliniken Zschadraß at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mantra Meditation, Mantra Meditation + Body-Oriented Yoga, Mantra Meditation + Ethical Living
- What is being tested?
- Ethical Living, Yoga Exercises and Mantra Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- 28 Mar 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- signed informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mantra Meditation, Mantra Meditation + Body-Oriented Yoga, Mantra Meditation + Ethical Living, Mantra Meditation + Body-Oriented Yoga + Ethical Living
- Being tested
- Ethical Living, Yoga Exercises, Mantra Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethical LivingBehavioural
Ethical principles based on Yoga philosophy, including contents of Yamas and Niyamas.
Yoga ExercisesBehavioural
Ujjaii breathing and simple yoga asanas
Mantra MeditationBehavioural
Meditation with mantras
| Study group | Role | What they receive |
|---|---|---|
| Mantra Meditation | Experimental | 8 weeks of mantra meditation with weekly group sessions. Receives: Behavioral: Mantra Meditation |
| Mantra Meditation plus Ethical Practice | Experimental | 8 weeks of mantra meditation plus ethical practice with weekly group sessions. Receives: Behavioral: Ethical Living; Behavioral: Mantra Meditation |
| Mantra Meditation plus Yoga Exercises | Experimental | 8 weeks of mantra meditation plus Yoga Exercises with weekly group sessions. Receives: Behavioral: Yoga Exercises; Behavioral: 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. Receives: Behavioral: Ethical Living; Behavioral: Yoga Exercises; Behavioral: Mantra Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Well-Being
WHO (Five) Well-Being Index (WHO-5)
Measured: Change from baseline Well-Being at 8 Weeks
Change of Mind-Wandering
Mind Wandering Questionnaire
Measured: Change from baseline Mind-Wandering at 8 Weeks
Change of Emotion regulation
Difficulties in Emotion Regulation Scale (DERS)
Measured: Change from baseline Emotion Regulation at 8 Weeks
Change of Perceived Stress
Perceived Stress Scale (PSS)
Measured: Change from baseline Stress at 8 Weeks
Change of Attention
Sustained Attention to Response Task
Measured: Change from baseline Attention at 8 Weeks
Change of Body Awareness
Body Awareness Questionnaire
Measured: Change from baseline body awareness at 8 Weeks
Life Satisfaction
Satisfaction with Life Scale
Measured: Change from baseline life satisfaction at 8 Weeks
Course satisfaction
Client Satisfaction Questionnaire
Measured: After 8 weeks of intervention
Adverse Events
70 possible adverse events or extraordinary experiences associated with meditation or yoga practice.
Measured: After 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start28 Mar 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mantra MeditationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * 4 Treatment Conditions: * Multiple-baseline design: 3 Baselines (7, 14, 21 days)
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonie Kliniken Zschadraß
- Sponsor type
- University, hospital or other
- Collaborators
- Chemnitz University of Technology
- Responsible party
- Principal investigator, Holger C. Bringmann, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252976
- Sponsor's protocol ID
- MBLM-H
- Acronym
- MBLM-H
- Status last verified
- Apr 2021
- First submitted
- 30 Jan 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be made available for free online access.
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.
PubMed 34421729
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation Based Lifestyle Modification in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04252976
- Acronym / sponsor ID
- MBLM-H / MBLM-H
- Conditions
- Mantra Meditation, Mantra Meditation + Body-Oriented Yoga, Mantra Meditation + Ethical Living, Mantra Meditation + Body-Oriented Yoga + Ethical Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Diakonie Kliniken ZschadraßUniversity, hospital or other
- Collaborators
- Chemnitz University of Technology
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- * 4 Treatment Conditions: * Multiple-baseline design: 3 Baselines (7, 14, 21 days)
| Arm | Type | Receives |
|---|---|---|
| Mantra Meditation | Experimental | Behavioral: Mantra Meditation8 weeks of mantra meditation with weekly group sessions. |
| Mantra Meditation plus Ethical Practice | Experimental | Behavioral: Ethical Living, Behavioral: Mantra Meditation8 weeks of mantra meditation plus ethical practice with weekly group sessions. |
| Mantra Meditation plus Yoga Exercises | Experimental | Behavioral: Yoga Exercises, Behavioral: Mantra Meditation8 weeks of mantra meditation plus Yoga Exercises with weekly group sessions. |
| Mantra Meditation plus Yoga Exercises plus Ethical Practice | Experimental | Behavioral: Ethical Living, Behavioral: Yoga Exercises, Behavioral: Mantra Meditation8 weeks of mantra meditation plus Yoga Exercises plus ethical practice with weekly group sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- signed informed consent
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethical LivingEthical principles based on Yoga philosophy, including contents of Yamas and Niyamas. | Behavioural | Mantra Meditation plus Ethical Practice, Mantra Meditation plus Yoga Exercises plus Ethical Practice |
| Yoga ExercisesUjjaii breathing and simple yoga asanas | Behavioural | Mantra Meditation plus Yoga Exercises, Mantra Meditation plus Yoga Exercises plus Ethical Practice |
| Mantra MeditationMeditation with mantras | Behavioural | Mantra Meditation, Mantra Meditation plus Ethical Practice, Mantra Meditation plus Yoga Exercises, Mantra Meditation plus Yoga Exercises plus Ethical Practice |
Primary outcome
Change of Well-Being
Time frame: Change from baseline Well-Being at 8 Weeks
WHO (Five) Well-Being Index (WHO-5)
Change of Mind-Wandering
Time frame: Change from baseline Mind-Wandering at 8 Weeks
Mind Wandering Questionnaire
Change of Emotion regulation
Time frame: Change from baseline Emotion Regulation at 8 Weeks
Difficulties in Emotion Regulation Scale (DERS)
Change of Perceived Stress
Time frame: Change from baseline Stress at 8 Weeks
Perceived Stress Scale (PSS)
Change of Attention
Time frame: Change from baseline Attention at 8 Weeks
Sustained Attention to Response Task
Change of Body Awareness
Time frame: Change from baseline body awareness at 8 Weeks
Body Awareness Questionnaire
Life Satisfaction
Time frame: Change from baseline life satisfaction at 8 Weeks
Satisfaction with Life Scale
Course satisfaction
Time frame: After 8 weeks of intervention
Client Satisfaction Questionnaire
Adverse Events
Time frame: After 8 weeks of intervention
70 possible adverse events or extraordinary experiences associated with meditation or yoga practice.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Derived from this study: PubMed 34421729Matko 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.
- Individual participant dataSharing planned: Yes. All data will be made available for free online access.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethical Living, Yoga Exercises and Mantra Meditation in people with Mantra Meditation and Mantra Meditation + Body-Oriented Yoga, run by Diakonie Kliniken Zschadraß at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Well-Being (time frame: Change from baseline Well-Being at 8 Weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.