Meditation Based Lifestyle Modification in Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-27

Study Completion Date

2020-07-20

Brief Summary

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

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Detailed Description

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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

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control 2

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

Group Type ACTIVE_COMPARATOR

Multimodal specific treatment:

Intervention Type OTHER

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

Intervention

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

Group Type EXPERIMENTAL

Meditation Based Lifestyle Modification

Intervention Type BEHAVIORAL

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

Control I

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

Group Type ACTIVE_COMPARATOR

Minimal treatment

Intervention Type OTHER

Drug continuation under medical supervision

Multimodal specific treatment:

Intervention Type OTHER

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

Interventions

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Meditation Based Lifestyle Modification

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

Intervention Type BEHAVIORAL

Minimal treatment

Drug continuation under medical supervision

Intervention Type OTHER

Multimodal specific treatment:

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No