Meditation Based Lifestyle Modification in Depression: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change of Beck Depression Index BDI-II
研究概览
简要总结
To evaluate effectiveness of a 8-week behavioral Mind-Body-Intervention based on Yoga and Meditation in depressive outpatients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Meditation Based Lifestyle Modification (Behavioral)
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
干预措施: Minimal treatment (Other)
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
干预措施: Multimodal specific treatment: (Other)
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
干预措施: Multimodal specific treatment: (Other)
结局指标
主要结局
Change of Beck Depression Index BDI-II
时间窗: Baseline, 4 weeks, 8 weeks. Follow-up 24 weeks
Change of depressive Symptoms
次要结局
- Heart Rate(8 weeks continuously in 1-minute intervals)
- Duke University Religion Index (DUREL)(Baseline, 8 weeks; Follow-up 24 weeks)
- Assessment of training and exercise hours(Daily for 8 weeks in intervention group)
- Heart Rate Variability(24h continuous measurement at Baseline, and at 8 weeks)
- Mindful Attention Awareness Scale (MAAS)(Baseline, 8 weeks; Follow-up 24 weeks)
- Freiburg Mindfulness Inventory (FMI)(Baseline, 8 weeks; Follow-up 24 weeks)
- Triguna Scale (TGS)(Baseline, 8 weeks; Follow-up 24 weeks)
- Aspects of Spirituality (ASP)(Baseline, 8 weeks; Follow-up 24 weeks)
- Perceived Stress Scale (PSS-10)(Baseline, 8 weeks; Follow-up 24 weeks)
- Transgression-Related Interpersonal Motivations Inventory (TRIM)(Baseline, 8 weeks; Follow-up 24 weeks)
- Brief global measure of client satisfaction (ZUF-8)(Baseline, 8 weeks; Follow-up 24 weeks)
- Qualitative Interview(After 8 or 24 weeks)
- Brief Symptom Checklist (BSI-18)(Baseline, 8 weeks; Follow-up 24 weeks)
- Aachen Self-Efficacy Questionnaire (Aachener Selbstwirksamkeitsfragebogen, [ASF])(Baseline, 8 weeks; Follow-up 24 weeks)
- SpREUK-P-SF17(Baseline, 8 weeks; Follow-up 24 weeks)
- Perseverative Thinking Questionnaire (PTQ)(Baseline, 8 weeks; Follow-up 24 weeks)
- Spirituality as a Resource to Rely on in Chronic Illness (SpREUK-15)(Baseline, 8 weeks; Follow-up 24 weeks)
- Activity: Steps per day(8 weeks continuously)
- Sleep duration(8 weeks continuously)
研究者
Holger C. Bringmann
Dr. med. B. Sc.
Charite University, Berlin, Germany