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Depressive DisorderMBLM-DNCT03652220

Meditation Based Lifestyle Modification in Depression

A study testing Meditation Based Lifestyle Modification, Minimal treatment and Multimodal specific treatment: in people with Depressive Disorder, run by Diakonie Kliniken Zschadraß at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate effectiveness of a 8-week behavioral Mind-Body-Intervention based on Yoga and Meditation in depressive outpatients. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Depressive Disorder
What is being tested?
Meditation Based Lifestyle Modification, Minimal treatment and Multimodal specific treatment:
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteGermany
Study dates
27 Aug 2018to 20 Jul 2020
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet the following criteria to be enrolled:
  • Outpatients
  • Written informed consent by patients who are competent to consent to study participation
  • Diagnosis of current mild or moderate episode of depression diagnosed by a consultant psychiatrist
  • Male or female ≥18 years of age
  • BDI-II >= 10
  • Patients must be physically able to perform simple Yoga postures and to sit silently for 20 minutes

Who cannot join

  • Patients will be excluded for ANY ONE of the following reasons:
  • Psychotic Symptoms
  • Acute suicidal tendencies
  • Compulsive disorders
  • Cerebro-organic diseases with clinically relevant symptoms
  • Severe multimorbidity
  • Clinically relevant addictions (tobacco abuse or addiction is allowed)
  • Current participation in another trial

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Diakoniekliniken Zschadraß

    Colditz, Saxony, 04680

Other trials in Germany

About this study

Official title: Meditation Based Lifestyle Modification in Depression: a Randomized Controlled Trial

To evaluate effectiveness of a 8-week behavioral Mind-Body-Intervention based on Yoga and Meditation in depressive outpatients.

Read the detailed description

As a contribution to the field of Integral Medicine, Meditation Based Lifestyle Modification (MBLM) is a holistic therapy for patients with mental disorders. Influenced by Ayurveda and Yoga, it uses mantra meditation, ethical conduct and healthy life style to promote physical, mental and spiritual health. MBLM explains processes within the body and the mind and their relation to diet, exercise, biorhythms, social and personal conduct in an easy but profound way and on an experiential level. Besides providing tools for physical, mental and emotional self-regulation, MBLM lays ground for personal growth and transcendence of the mind. It is intended to be implemented in groups of patients as well as individual daily training, and because of its modular structure can be adjusted in intensity, duration and weighting of the components according to the specific needs and disorders to be addressed. This makes it also eligible for its potential use in prevention of mental disease and treatment of psychic comorbidities in patients with chronic somatic illness.

Being tested
Meditation Based Lifestyle Modification, Minimal treatment, Multimodal specific treatment:
Medical subject headings
Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meditation Based Lifestyle ModificationBehavioural

    8 weekly modules, each 3.5 hours of Life ethics, Yoga exercises and Mantra Meditation

  • Minimal treatmentOther

    Drug continuation under medical supervision

  • Multimodal specific treatment:Other

    Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR

Study groups in NCT03652220
Study groupRoleWhat they receive
InterventionExperimental8 weeks Minimal treatment + MBLM 16 weeks Multimodal specific treatment + MBLM Consolidation Definitions Minimal treatment: drug continuation under medical supervision Multimodal specific treatment: Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR MBLM: 8-week course Meditation Based Lifestyle Modification MBLM-Consolidation: weekly Mantra-Meditation, monthly Life-Ethics
Receives: Behavioral: Meditation Based Lifestyle Modification
Control IActive comparator8 weeks Minimal treatment 16 weeks Multimodal specific treatment Definitions Minimal treatment: drug continuation under medical supervision Multimodal specific treatment: Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR MBLM: 8-week course Meditation Based Lifestyle Modification MBLM-Consolidation: weekly Mantra-Meditation, monthly Life-Ethics
Receives: Other: Minimal treatment; Other: Multimodal specific treatment:
Control 2Active comparatorDefinitions 24 weeks Multimodal specific treatment Minimal treatment: drug continuation under medical supervision Multimodal specific treatment: Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR MBLM: 8-week course Meditation Based Lifestyle Modification MBLM-Consolidation: weekly Mantra-Meditation, monthly Life-Ethics
Receives: Other: Multimodal specific treatment:

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Beck Depression Index BDI-II

    Change of depressive Symptoms

    Measured: Baseline, 4 weeks, 8 weeks. Follow-up 24 weeks

Secondary outcomes (19)
  1. Freiburg Mindfulness Inventory (FMI)

    The FMI (14 item version; FMI-14) is a widely used instrument that assesses trait mindfulness that has been validated in a number of studies. This short form of the originally 30-items questionnaire provides robust and psychometrically stable (alpha = .86) properties. It is semantically independent from a Buddhist or meditation context (Walach, Buchheld, Buttenmüller, Kleinknecht, \& Schmidt, 2006).

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  2. Mindful Attention Awareness Scale (MAAS)

    The MAAS (K. W. Brown \& Ryan, 2003) is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. The scale shows strong psychometric properties and has been validated with college, community, and cancer patient samples. Correlational, quasi-experimental, and laboratory studies have shown that the MAAS taps a unique quality of consciousness that is related to, and predictive of, a variety of self-regulation and well-being constructs.

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  3. Perceived Stress Scale (PSS-10)

    The Perceived Stress Scale (Cohen, Kamarck, \& Mermelstein, 1983) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress.

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  4. Brief Symptom Checklist (BSI-18)

    The BSI-18 (Franke et al., 2017) contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensional versions of the commonly used Symptom-Checklist 90-R.

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  5. Aachen Self-Efficacy Questionnaire (Aachener Selbstwirksamkeitsfragebogen, [ASF])

    The ASF assesses generalized self-efficacy as well as specific factors such as achievement, social interaction and body- related self esteem. Its internal consistency (Chronbach's α) is 0.90 for the general scale, and 0.74-0.84 for its subscales. The test-retest reliability for the ASF is rtt 0.66 over a period of eight weeks (Flatten, Wälte, \& Perlitz, 2008).

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  6. SpREUK-P-SF17

    This instrument (Bussing, Reiser, Michalsen, \& Baumann, 2012) was designed to measure the engagement frequencies of a large spectrum of organized and private religious, spiritual, existential and philosophical practices. It avoids the intermix of cognitive / emotional attitudes and convictions on the one hand with the engagement in forms of practice (action, behaviour) on the other. To account for the fact of institutional religiosity declines not only in Europe, and the alternative use of various existing esoteric and religious resources, the instrument differentiates both the frequency of conventional forms of spirituality/religiosity, and also more reflecting or philosophical practice and nature/environment- oriented practices.

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  7. Triguna Scale (TGS)

    TGS is an instrument to rate a variety of psychosocial traits (e.g. cognition, motivation, social behavior etc.) according to tri-guna model of Yoga philosophy (M. Puta, 2016; Maika Puta \& Sedlmeier, 2014). The reliability of the majority of the 27 scales corresponds to reliability values of established personality inventories: Cronbach's α of 24 subscales is above .7. The internal consistencies of the other three subscales don't meet this standard, but their values are still above .6. Measures determining the validity of the inventory are very good. The exploratory factor analysis of the second study shows that all scales consist of three factors, each of which can be related to one of the gunas.

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  8. Transgression-Related Interpersonal Motivations Inventory (TRIM)

    The TRIM is a self-report instrument that assesses the motivations assumed to underlie forgiving: Avoidance and Revenge. Responses to 12 statements referring to a transgression recipient's current thoughts and feelings about the transgressor are scored on a 5-point Likert-type scale. Recently, a six-item subscale to reflect benevolent motivations toward the transgressor has been under development (contact the first author for details). The TRIM subscales not only correlate with a variety of relationship, offense, and social-cognitive variables, they have also demonstrated strong relationships to a single-item measure of forgiveness. The inventory takes approximately 5 minutes to complete (McCullough et al., 1998).

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  9. Brief global measure of client satisfaction (ZUF-8)

    ZUF-8 is a global, one-dimensional patient satisfaction measurement tool. It is the German-language adaptation of the American CSQ-8 by Attkisson \& Zwick (1982). Over eight items, the general satisfaction with aspects of the clinic or the received treatment is recorded. ZUF-8 is particularly suitable for economical screening of patient satisfaction (Schmidt, Lamprecht, \& Wittmann, 1989).

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  10. Perseverative Thinking Questionnaire (PTQ)

    The PTQ (Ehring et al., 2011) is a 15-item questionnaire assessing the tendency to engage in repetitive negative thinking independent of a disorder-specific content. Items are rated on a scale ranging from 0 (never) to 4 (almost always). The PTQ consists of three subscales: Core features of repetitive negative thinking (sample item: 'The same thoughts keep going through my mind again and again'.), perceived unproductiveness of repetitive negative thinking (sample item: 'I keep asking myself questions without finding an answer'.), and repetitive negative thinking capturing mental capacity (sample item: 'My thoughts prevent me from focusing on other things'.). Confirmatory factor analysis provides support for a 3-factor solution.

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  11. Duke University Religion Index (DUREL)

    The Duke University Religion Index (DUREL) is a five-item measure of religious involvement, and was developed for use in large cross-sectional and longitudinal observational studies. The instrument assesses the three major dimensions of religiosity that were identified during a consensus meeting sponsored by the National Institute on Aging. Those three dimensions are organizational religious activity, non-organizational religious activity, and intrinsic religiosity (or subjective religiosity). The DUREL measures each of these dimensions by a separate "subscale", and correlations with health outcomes should be analyzed by subscale in separate models.

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  12. Aspects of Spirituality (ASP)

    The ASP questionnaire was developed to measure a wide variety of vital aspects of spirituality beyond conventional conceptual boundaries in secular societies. Both expert representatives of various spiritual orientations and also atheists were asked which aspects of spirituality are relevant to them (Büssing, 2006). Identified motifs we condensed to 40 items of the Aspects of Spirituality (ASP 1.0) questionnaire (7 factors; Cronbach ́s alpha = .94) (Büssing et al., 2007) which differentiates and quantifies cognitive, emotional, intentional and action-oriented matters of theism/belief, (esoteric) transcendence, existentialism, humanism etc. The reliable and valid instrument is suited to be used in health care research (Büssing et al. 2007).

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  13. Spirituality as a Resource to Rely on in Chronic Illness (SpREUK-15)

    The SpREUK was developed to investigate whether or not patients with chronic diseases living in secular societies rely on spirituality as a resource to cope with illness. The SpREUK questionnaire relies on essential motifs found in counseling interviews with chronic disease patients (i.e., having trust/faith; search for a transcendent source to rely on; reflection of life and subsequent change of life and behavior). The instrument is suited to be used in health care research (A Büssing, Ostermann, \& Matthiessen, 2005).

    Measured: Baseline, 8 weeks; Follow-up 24 weeks

  14. Assessment of training and exercise hours

    Patients receive weekly working sheets to document daily, cumulative duration of practice.

    Measured: Daily for 8 weeks in intervention group

  15. Heart Rate Variability

    Faros eMotion 180 derived 3-lead ECG Heart Rate Variability (RR-Intervals in ms)

    Measured: 24h continuous measurement at Baseline, and at 8 weeks

  16. Heart Rate

    FitBit Charge 2 derived Heart Rate (beats per minute)

    Measured: 8 weeks continuously in 1-minute intervals

  17. Sleep duration

    FitBit Charge 2 derived sleep duration in minutes

    Measured: 8 weeks continuously

  18. Activity: Steps per day

    FitBit Charge 2 derived steps per day

    Measured: 8 weeks continuously

  19. Qualitative Interview

    A single qualitative interview with selected patients (around 10 patients in each group) will be held after at least 8 weeks of treatment to assess qualitative data:

    Interviews will involve the following domains of exploration

    1. How has the treatment you have received during the last weeks has affected your depression?
    2. How did you experience the treatment?
    3. What does spirituality mean to you and how has that changed during the treatment?

    Interviews are an optional part of the study in terms of a mixed model approach to receive quantitative and qualitative data as well. Participants willing to be interviewed have to sign an additional consent for the collection and processing of personal interview data.

    Measured: After 8 or 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2018
  2. Study start27 Aug 2018
  3. Primary completion20 Jul 2020
  4. Study completion20 Jul 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a three-arm, randomized, active-controlled, unblinded, parallel, exploratory study to compare the outcome in depression between standard specific treatment, multimodal specific treatment and standard treatment plus MBLM. After being screened for eligibility and signing the informed consent patients will be randomized 1:1:1 to either one of the groups. After being enrolled, patients in MBLM group receive an introductory education of the MBLM course and then join group sessions weekly for 8 weeks. They also see a consultant psychiatrist as needed for drug continuation therapy. Patients should practice MBLM related content at home for a proposed duration of 30-45 minutes per day. Patients in the control groups receive standard (control group I) or multimodal (control group II) treatment as administered by their consultant psychiatrist.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03652220
Sponsor's protocol ID
MBLM-D
Acronym
MBLM-D
Status last verified
Jul 2022
First submitted
22 Aug 2018
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bringmann HC, Berghofer A, Jeitler M, Michalsen A, Brunnhuber S, Haller H. Meditation-Based Lifestyle Modification in Mild-to-Moderate Depression: Outcomes and Moderation Effects of Spirituality. J Integr Complement Med. 2024 Jun;30(6):532-542. doi: 10.1089/jicm.2023.0179. Epub 2023 Nov 27.

    PubMed 38011739
  • Bringmann HC, Vennemann J, Gross J, Matko K, Sedlmeier P. "To Be Finally at Peace with Myself": A Qualitative Study Reflecting Experiences of the Meditation-Based Lifestyle Modification Program in Mild-to-Moderate Depression. J Altern Complement Med. 2021 Sep;27(9):786-795. doi: 10.1089/acm.2021.0038. Epub 2021 Jun 29.

    PubMed 34185550

Questions about this trial

What is this clinical trial studying?

A study testing Meditation Based Lifestyle Modification, Minimal treatment and Multimodal specific treatment: in people with Depressive Disorder, 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 7 inclusion and 8 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 27 Jul 2022. 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 Beck Depression Index BDI-II (time frame: Baseline, 4 weeks, 8 weeks. Follow-up 24 weeks). 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 NCT03652220, which also lists 2 linked publications.

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 27 Jul 2022.

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