An Objective Comparison of Cognitive Behavioral Therapy and Mindfulness-based Stress Reduction for the Treatment of Insomnia in Cancer Survivors Using Wrist Actigraphy: A Randomized Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity from baseline to 3 months
研究概览
简要总结
Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.
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 (Participant)
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
- •English speaking
- •Non metastatic cancer
- •1 month post chemotherapy/radiation treatment (hormone treatment okay)
- •Diagnosis of Primary or Secondary Insomnia
排除标准
- •Presence of another sleep disorder
- •Presence of another Axis I diagnosis (not in remission)
- •Inability to attend at least 5 out of the 8 treatment sessions
- •Randomization Refusal
- •Previous participation in CBT-I or MBSR
- •Shift work
结局指标
主要结局
Change in Insomnia Severity from baseline to 3 months
时间窗: Baseline, Post-Treatment, 3 month follow up
次要结局
- Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months(Baseline (one week), During treatment (7 weeks), Post Treatment (1 week), 3 month Follow up (1 week))
- Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months(Baseline, Post Treatment, 3 month folllow up)
- Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months(Baseline, Post Treatment, 3 month follow up)
- Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months(Baseline, Post Treatment, 3 month folllow up)
- Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months(Baseline, Post Treatment, 3 month follow up)
- Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months(Baseline, Post Treatment, 3 month folllow up)
研究者
Tavis S. Campbell
Associate Professor of Psychology
University of Calgary