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临床试验/NCT02686333
NCT02686333已完成3 期

Meditation Intervention for the Treatment of Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Randomized Control Trial

Lady Davis Institute2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年3月1日最近更新:
适应症

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

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

发起方
Lady Davis Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Karl Looper

MD, FRCPC, Chief of the Department of Psychiatry, Jewish General Hospital

Lady Davis Institute

研究点 (2)

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