Clinical trial NCT03652220: Meditation Based Lifestyle Modification in Depression
Official title: Meditation Based Lifestyle Modification in Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Diakonie Kliniken Zschadraß
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Chemnitz University of Technology
First posted: 2018-08-29
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

Subjects must meet the following criteria to be enrolled:

1. Outpatients
2. Written informed consent by patients who are competent to consent to study participation
3. Diagnosis of current mild or moderate episode of depression diagnosed by a consultant psychiatrist
4. Male or female ≥18 years of age
5. BDI-II \>= 10
6. Patients must be physically able to perform simple Yoga postures and to sit silently for 20 minutes

Exclusion Criteria:

Patients will be excluded for ANY ONE of the following reasons:

1. Psychotic Symptoms
2. Acute suicidal tendencies
3. Compulsive disorders
4. Cerebro-organic diseases with clinically relevant symptoms
5. Severe multimorbidity
6. Clinically relevant addictions (tobacco abuse or addiction is allowed)
7. Current participation in another trial

Primary outcomes:
measure: Change of Beck Depression Index BDI-II
timeFrame: Baseline, 4 weeks, 8 weeks. Follow-up 24 weeks
Secondary outcomes:
measure: Freiburg Mindfulness Inventory (FMI)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Brief Symptom Checklist (BSI-18)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Aachen Self-Efficacy Questionnaire (Aachener Selbstwirksamkeitsfragebogen, [ASF])
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: SpREUK-P-SF17
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Triguna Scale (TGS)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Transgression-Related Interpersonal Motivations Inventory (TRIM)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Brief global measure of client satisfaction (ZUF-8)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Duke University Religion Index (DUREL)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Aspects of Spirituality (ASP)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Spirituality as a Resource to Rely on in Chronic Illness (SpREUK-15)
timeFrame: Baseline, 8 weeks; Follow-up 24 weeks
measure: Assessment of training and exercise hours
timeFrame: Daily for 8 weeks in intervention group
measure: Heart Rate Variability
timeFrame: 24h continuous measurement at Baseline, and at 8 weeks
measure: Heart Rate
timeFrame: 8 weeks continuously in 1-minute intervals
measure: Sleep duration
timeFrame: 8 weeks continuously
measure: Activity: Steps per day
timeFrame: 8 weeks continuously
measure: Qualitative Interview
timeFrame: After 8 or 24 weeks
Other outcomes:
Locations:
city: Colditz
country: Germany
facility: Diakoniekliniken Zschadraß
state: Sachsen
Study officials:
References:
citation: 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.