Meditation Intervention for the Treatment of Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of participants who enrolled who completed the 8 week-trial
研究概览
简要总结
This study examines the use of brief meditation interventions for patients with symptoms of anxiety and depression who are undergoing dialysis. Half of the participants will receive meditation interventions 3 times a week, while the other half will receive treatment as usual. This study will examine whether meditation is feasible and whether it has any effect on reducing symptoms of anxiety or depression.
详细描述
Roughly 50% of people who undergo dialysis experience stress, anxiety or depression, but often these conditions go undetected and untreated. It is known that meditation is helpful for anxiety and depression, especially in people who have chronic health conditions. This study will look specifically at meditation interventions tailored to the dialysis setting. Patients on maintenance hemodialysis with anxiety and depression will be recruited from hemodialysis units. Recruitment will start at the Jewish General Hospital in March 2016. Recruitment may later expand to University Health Network (Toronto), and/or other sites affiliated with McGill University or University of Toronto.
Participants will then be randomly assigned to receive meditation or continue with their usual treatment. The participants assigned to the meditation group will practice several meditation techniques with a trained interventionist 3 times a week, during their dialysis sessions.
At the end of the 8 weeks, the investigators will assess whether the meditation intervention was feasible (i.e. whether recruitment goals were met and drop out rates were as expected). Participants in the meditation group will be asked to rate whether they enjoyed the meditation on a scale. Both the participants assigned to the meditation group and to the usual treatment group will be asked to rate their depression and anxiety symptoms on the PHQ-9 and the GAD-7 scales to evaluate whether there was any change.
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
- •Patients currently receiving maintenance hemodialysis
- •Patients with depression and/or anxiety as indicated by scores of ≥10 on the Patient Health Questionnaire (PHQ-9) and/or General Anxiety Disorder-7 (GAD- 7)
- •Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test)
排除标准
- •Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)
- •Acute psychotic symptoms
- •Acute Suicidal ideation/intent
结局指标
主要结局
Proportion of participants who enrolled who completed the 8 week-trial
时间窗: 34 months
Tolerability of Meditation Intervention on a 10-point Likert scale
时间窗: 8 weeks
Tolerability of intervention on a 10-point Likert scale
Proportion of participants screened as eligible who enroll
时间窗: 34 months
次要结局
- Change in General Anxiety Disorder-7 (GAD-7)(Baseline and at 8 weeks)
- Change in Patient Health Questionnaire (PHQ-9)(Baseline and at 8 weeks)
研究者
Dr. Karl Looper
MD, FRCPC, Chief of the Department of Psychiatry, Jewish General Hospital
Lady Davis Institute
