Mantra Meditation as Adjunctive Therapy in Major Depression: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- MADRS / SIGMA
研究概览
简要总结
To evaluate effects of mantra meditation on depressive symptoms if applied as adjunctive therapy to psychotherapy and/or antidepressant drugs and to explore if meditation leads to increased spirituality as a potential mediating factor of positive mental health.
详细描述
Primary objective To measure the difference in efficacy between treatment as usual (TAU) + Mantra meditation (MAM) 20min per day and TAU + progressive muscle relaxation (PMR) 20min per day in the treatment of depressive symptoms in patients with Major Depression after inpatient treatment, after 3 months and after 6 months of treatment as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).
Secondary objectives (exploratory)
- Differences between and within groups in self-rated depression, rumination, automatic negative thinking or trait-anxiety.
- Differences between and within groups in measures of spirituality.
- Correlation between measures of spirituality and change of psychometric scores.
- Change in stress response and relaxation response after inpatient treatment, compared to baseline.
- Difference in adherence and depth of practice between groups and within groups and correlation to psychometric outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients of open psychiatric ward
- •Written informed consent by patients who are competent to consent to study participation
- •Diagnosis of current episode of major depression as defined by DSM-IV criteria and diagnosed via structured interview (SKID) by a trained psychiatrist or psychologist. DSM-IV codes: 296.22, 296.23, 296.32, 296.
- •Corresponding ICD-10 codes: F32.1, F32.2, F33.1, F33.
- •Male or female ≥18 years of age
- •BDI-II >= 20
- •Patients must be able to sit in a chair for at least 20 minutes
- •Patients live in the catchment area of the hospital
排除标准
- •Patients will be excluded for ANY ONE of the following reasons:
- •Any other current major psychiatric disorder is an exclusion criterion EXCEPT for the following:
- •Abuse of nicotine or dependence of nicotine;
- •Agoraphobia with or without Panic Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Specific Phobia, Social Phobia
- •Hypochondriasis, Pain Disorder, Somatization Disorder, Undifferentiated Somatoform Disorder
- •Sexual and Gender Identity Disorders
- •Eating disorders
- •Psychotic symptoms that are not compatible with diagnosis of unipolar depression
- •Acute suicidality
- •Diagnosis affecting cortisol levels such as type I diabetes mellitus, cancer, asthma, chronic hepatitis, chronic fatigue syndrome, or regular use of medications having an immuno-modulary effect (e.g. cytotoxic chemotherapy, corticosteroids, interferons);
- •Current practice of other forms of Mantra repetition such as the rosary, chanting, or Transcendental Meditation
- •Current participation in another trial
结局指标
主要结局
MADRS / SIGMA
时间窗: 6 months
The clinician-rated Montgomery and Asberg Depression Rating Scale (MADRS) \[reproduced in the Appendix to this chapter\] was developed in the late 1970s (Montgomery \& Asberg, 1979) and this 10-item scale was designed to be sensitive to the effects of antidepressant medications, primarily tricyclic antidepressants. One of the original goals of the MADRS was to obtain an instrument that could be used by both psychiatrists and professionals without a specific or with minimal psychiatric training. From the original report of the MADRS, the inter-rater reliability ranged from 0.89 to 0.97. However, in a German study, significant differences resulted when the same patient was rated by various groups of caregivers (as described in Cusin, Yang, Yeung, \& Fava, 2010). Hence, a structured interview guide (SIGMA) that has been developed for the MADRS (Williams, Kobak, \& Montgomery, 2008) will be used in this study by trained psychologists exclusively.
次要结局
- RSQ(6 months)
- STAI-T(6 months)
- EEQ(6 months)
- ICPH(6 months)
- PTQ(6 months)
- HRV(1 month)
- ASP(6 months)
- SpREUK(6 months)