A Spirituality Teaching Program for Depression in Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale - Depression Severity
研究概览
简要总结
Major depression is a widely spread health problem in Canada. Recent research suggests a potential role for religion/spirituality in the prevention of and recovery from depression in adults. The purpose this study was to assess the efficacy of a home-based Spirituality Teaching Program for adults in the treatment of major depression. The objectives of the study were to determine:
- whether the Spirituality Teaching Program is efficacious in improving depression severity, response rate, and remission rate in adults,
- whether efficacy is maintained long term (over a 16 week period).
详细描述
Major depression is a widely spread health problem in Canada with a life time prevalence of 11% in men and 16% in women. A recent avenue of research suggests a role for religion/spirituality in the prevention of and recovery from depression. It has been hypothesized that religion/spirituality acts as a coping resource in distressing life situations including illness and loss and may address the struggles of depressed patients of feeling separated from their surrounding world, as well as from their inner self. Majority of the research conducted to date on this topic has been observational and focused on the religious denomination, primarily the Christian and Muslim faiths. However, given the distinction between spirituality and religion and since a growing portion of the Canadian population identifies themselves as nonreligious but spiritual (10), it is pertinent to explore whether there is a role for a nondenominational spiritual intervention as a mental health resource. Considering the burden of depression on an individual and social level and need for effective and accessible treatment options, evaluation of spirituality based approaches is highly relevant. This study aims to assess whether nurturing spiritual coping resources in a non-faith based way may play a therapeutic role in recovery from major depression in adults.
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
- •Satisfy the DSM-IV criteria for unipolar major depression with a depression score of 18-22 on the Hamilton Depression Scale (mild to moderate severity),
- •Are at least 18 years of age,
- •Have the competence to understand the study requirements and the ability to comply with the study intervention,
- •Have provided written informed consent.
排除标准
- •History of treatment resistance to two or more antidepressants when treated for an adequate period with a therapeutic dose
- •History of bipolar d/o, psychotic d/o, any psychotic episodes, personality d/o (except obsessive compulsive d/o)
- •History of multiple suicide attempts
- •Acute psychiatric condition other than unipolar depression
- •Regular use of medications (other than antidepressant, if applicable) that have mood altering effects, such as narcotics, anticonvulsants, illicit drugs or sleeping pills
- •Uncontrolled medical conditions in the last 3 months
- •DSM-IV diagnosis of substance abuse (except nicotine and caffeine) within the past 12-months
- •High suicide risk
结局指标
主要结局
Hamilton Depression Rating Scale - Depression Severity
时间窗: baseline, 8 weeks, 16 weeks, and 24 weeks
Depression severity was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a standardized outcome measure of depression severity in adults. Total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. The HAM-D was administered through a face to face interview, which was conducted by a trained nurse who was blinded to participants' allocation.
次要结局
- Response Rate(baseline, 8 weeks, 16 weeks, and 24 weeks)
- Remission(baseline, 8 weeks, 16 weeks, and 24 weeks)
研究者
Badri Rickhi
Chair and Founding Member, CINIM
Canadian Institute of Natural and Integrative Medicine