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临床试验/NCT03250468
NCT03250468终止不适用

Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
52
试验地点
2
主要终点
Sleep Quality

研究概览

简要总结

Research aims:

  1. To determine if participation in a group-based cognitive behavioural therapy intervention (CBT-I) intervention results in improved sleep quality.
  2. To determine if participation in a group-based CBT-I intervention results in improved cardiovascular disease risk factors, and if the CBT-I intervention moderates that relationship.

详细描述

Cardiovascular disease affects 5% of the population and almost 20% of those meet the criteria for insomnia; twice as many as in the general population. Patients with cardiovascular disease and insomnia have been found to have elevated rates of anxiety and depression, which in turn places individuals at further cardiovascular risk via physiological pathways like increased blood pressure and/or vascular inflammation. Further, insomnia has been linked with negative health outcomes that exacerbate risk, including obesity, hypertension, and future acute myocardial infarction. Given the negative impact of poor sleep on cardiac health, some have argued that insomnia should now be included in the top 10 modifiable risk factors for cardiovascular disease.

Currently the best treatment for insomnia is a group-based cognitive behavioural therapy intervention (CBT-I); this intervention is more effective than pharmacotherapy. Evidence shows that CBT-I produces significant improvements after 6 weeks of intervention and improvements continue over the long term. This intervention program includes specific cognitive therapy exercises aimed at maladaptive thoughts about sleep, behaviour change techniques, and relaxation strategies (e.g., mindfulness, deep breathing); it also provides a supportive environment for individuals to discuss their sleep difficulties, allowing them to feel normalized and less isolated. For most people with insomnia however, their disorder goes untreated, leaving individuals at higher risk for affective disorders (e.g., depression), cardiovascular disease, and poorer quality of life. This lack of treatment is widespread and systemic; patients who want help with insomnia face a dearth of information about treatment, actual access to treatment and affordable services.

The proposed study is the first evaluation of a comprehensive CBT-I intervention designed for cardiac patients. Of note, the proposed study will be the first to evaluate the impact of this intervention on cardiovascular 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
Double (Investigator, 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

  • Sleep disturbance as indicated by a score on the Insomnia Severity Index (ISI) of 8 or above.
  • Enrolled in the cardiac rehabilitation program offered by the University of Ottawa Heart Institute.
  • Willing to be randomized.
  • Willing to wear a monitor that tracks sleep and physical activity.

排除标准

  • Untreated or undiagnosed obstructive sleep apnea (as per standard cardiac rehabilitation intake assessment, patients with a score of 5 or above on the STOP-BANG (a brief assessment for sleep apnea) will be referred for a sleep assessment by a cardiac rehabilitation physician).
  • Unable to converse in English (i.e., while patient materials and questionnaires will be offered in both English and French, the intervention is only offered in English).
  • Unable to provide written, informed consent.
  • Unable to attend 6 weeks of onsite CBT-I intervention.

结局指标

主要结局

Sleep Quality

时间窗: Through study completion, up to 3 months

Sleep quality will be measured using the Consensus Sleep Diary.

次要结局

  • Sleepiness(Through study completion, up to 3 months)
  • Mental Health(Through study completion, up to 3 months)
  • Sleep Symptoms(Through study completion, up to 3 months)
  • Activity(Through study completion, up to 3 months)
  • Quality of life(Through study completion, up to 3 months)
  • Cardiovascular Risk Factors(Through study completion, up to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Tulloch

Clinical Psychologist

Ottawa Heart Institute Research Corporation

研究点 (2)

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