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.
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:
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Depressive Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 8 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 I | Active comparator | 8 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 2 | Active comparator | Definitions 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.
Change of Beck Depression Index BDI-II
Change of depressive Symptoms
Measured: Baseline, 4 weeks, 8 weeks. Follow-up 24 weeks
Secondary outcomes (19)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Heart Rate
FitBit Charge 2 derived Heart Rate (beats per minute)
Measured: 8 weeks continuously in 1-minute intervals
Sleep duration
FitBit Charge 2 derived sleep duration in minutes
Measured: 8 weeks continuously
Activity: Steps per day
FitBit Charge 2 derived steps per day
Measured: 8 weeks continuously
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
- How has the treatment you have received during the last weeks has affected your depression?
- How did you experience the treatment?
- 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.
- First posted29 Aug 2018
- Study start27 Aug 2018
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Diakonie Kliniken Zschadraß
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Chemnitz University of Technology
- Responsible party
- Principal investigator, Holger C. Bringmann, Charite University, Berlin, Germany
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 38011739Bringmann 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation Based Lifestyle Modification in Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03652220
- Acronym / sponsor ID
- MBLM-D / MBLM-D
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Diakonie Kliniken ZschadraßUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Chemnitz University of Technology
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 29 Aug 2018 (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.
To evaluate effectiveness of a 8-week behavioral Mind-Body-Intervention based on Yoga and Meditation in depressive outpatients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Meditation Based Lifestyle Modification8 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 |
| Control I | Active comparator | Other: Minimal treatment, Other: Multimodal specific treatment:8 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 |
| Control 2 | Active comparator | Other: Multimodal specific treatment:Definitions 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Psychotic Symptoms
- Acute suicidal tendencies
- Compulsive disorders
- Cerebro-organic diseases with clinically relevant symptoms
- Severe multimorbidity
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 |
|---|---|---|
| Meditation Based Lifestyle Modification8 weekly modules, each 3.5 hours of Life ethics, Yoga exercises and Mantra Meditation | Behavioural | Intervention |
| Minimal treatmentDrug continuation under medical supervision | Other | Control I |
| Multimodal specific treatment:Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR | Other | Control 2, Control I |
Primary outcome
Change of Beck Depression Index BDI-II
Time frame: Baseline, 4 weeks, 8 weeks. Follow-up 24 weeks
Change of depressive Symptoms
19 secondary outcomes
Freiburg Mindfulness Inventory (FMI)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Perceived Stress Scale (PSS-10)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Brief Symptom Checklist (BSI-18)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Aachen Self-Efficacy Questionnaire (Aachener Selbstwirksamkeitsfragebogen, [ASF])
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
SpREUK-P-SF17
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Triguna Scale (TGS)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Transgression-Related Interpersonal Motivations Inventory (TRIM)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Brief global measure of client satisfaction (ZUF-8)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Perseverative Thinking Questionnaire (PTQ)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Duke University Religion Index (DUREL)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Aspects of Spirituality (ASP)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Spirituality as a Resource to Rely on in Chronic Illness (SpREUK-15)
Time frame: Baseline, 8 weeks; Follow-up 24 weeks
Assessment of training and exercise hours
Time frame: Daily for 8 weeks in intervention group
Heart Rate Variability
Time frame: 24h continuous measurement at Baseline, and at 8 weeks
Heart Rate
Time frame: 8 weeks continuously in 1-minute intervals
Sleep duration
Time frame: 8 weeks continuously
Activity: Steps per day
Time frame: 8 weeks continuously
Qualitative Interview
Time frame: After 8 or 24 weeks
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 27 Jul 2022.
- Derived from this study: PubMed 38011739Bringmann 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.
- Derived from this study: PubMed 34185550Bringmann 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.
- Individual participant dataSharing planned: Undecided
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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 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.