Reduce Emotional Symptoms of Insomnia With Sleep Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.
详细描述
Cognitive-behavioral therapy and pharmacotherapy are effective interventions for insomnia. Even so, about half of patients do not adequately respond to these treatments. Non-remission has been linked to high cognitive arousal that does not improve with traditional therapies. This study will examine the effects of mindfulness-based therapy for insomnia (MBTI) in a sample of patients who previously failed cognitive behavioral therapy and/or pharmacotherapy for insomnia.
This trial utilizes a single-arm, open label trial of MBTI. MBTI is delivered via telemedicine video in an individual therapy format.
Male and female participants who have insomnia, are age 18 and older, and who are recruited into the study will complete an initial assessment of their qualifications that are based on the severity of their insomnia symptoms, depression symptoms, and physical and mental health status. Eligible participants will undergo a clinical sleep interview and then complete 8 sessions of MBTI. Study outcomes are assessed via online survey before treatment, after treatment, and then a 6-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Determination of insomnia (ISI>10)
- •Inadequate response to prior insomnia psychotherapy (e.g., CBTI) and/or pharmacotherapy per patient report.
排除标准
- •Age < 18
- •Current use of antidepressants for depression
- •Bipolar or Seizure disorders
- •Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).
结局指标
主要结局
Insomnia Severity Index
时间窗: Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)
Five Facet Mindfulness Questionnaire-15 (FFMQ-15)
时间窗: Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion)
Five Facet Mindfulness Questionnaire - 15 (total scores ranges 15-75, with higher scores indicating someone who is more mindful in their everyday life.)
次要结局
未报告次要终点
研究者
Christopher Drake
Principal Investigator
Henry Ford Health System