Feasibility and Efficacy of an Internet-delivered Cognitive-behavioral Intervention for Insomnia in a National Cohort of Danish Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- The Pittsburgh Sleep Quality Index
研究概览
简要总结
The aim is, in a randomized controlled trial, to test the feasibility and evaluate the efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US cancer patients, in a large sample of Danish breast cancer survivors who are experiencing significant sleep problems 0-3 years after treatment. The investigators aim to test the following hypotheses: That a group receiving Internet-delivered cognitive-behavioral therapy (CCBT) for insomnia (CCBT-I) will experience reduced sleep latency, more hours of sleep, fewer awakenings during the night, improved sleep efficiency, increased subjective sleep quality, and improved quality of life after the intervention, when compared to a waiting list control group. The investigators also aim to explore a number of possible moderators of the effect (comorbidity, depression, fear of cancer recurrence tendency to ruminate) and mediating mechanisms (changes in sleep habits and sleep-related lifestyle factors).
详细描述
METHODS PARTICIPANTS
The participants are able, legally competent women, 18 years or older, from a national cohort of Danish women treated for primary breast cancer between 1st of June 2011 and 1st of Juli 2014:
Inclusion criteria: 1) Reported moderate-to-severe sleep disturbances, defined as a score> 5 on the Pittsburgh Sleep Quality Index (PSQI) (32;33) (see below), and 2) are found to be disease free. Furthermore, participants 3) are required to have access to the Internet.
Exclusion criteria: 1) Recurrence of breast cancer, 2) a second cancer, 3) and other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD), 4) shift work schedule, 5) other sleep disorders (sleep apnea, narcolepsy).
PROCEDURE INFORMATION AND REQUEST TO PARTICIPATE Women who fulfill the inclusion criteria and indicate an interest in receiving further information receive an information folder by post informing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Reported moderate-to-severe sleep disturbances, defined as a score> 5 on the Pittsburgh Sleep Quality Index (PSQI).
- •Disease free.
- •Access to the Internet.
排除标准
- •Recurrence of breast cancer
- •A second cancer
- •Other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD)
- •Night work schedule
- •Other sleep disorders (sleep apnea, narcolepsy) .
结局指标
主要结局
The Pittsburgh Sleep Quality Index
时间窗: Up to 7 month
The Insomnia Severity Index
时间窗: Up to 7 month
Sleep diary
时间窗: Up to 7 month
The online sleep diaries contains 10 standard questions including information about bedtime, sleep onset latency (SOL), number of awakenings, total length of awakenings, wake time, arising time, daytime naps, rating of soundness of previous night's sleep, rating of refreshed feeling upon morning awakening, and information about sleep aids (medication and/or alcohol use).
次要结局
- Functional Assessment of Chronic Illness Therapy (FACIT)(Up to 7 month)
- EQ-5D(Up to 7 month)
- Cognitive Failures Questionnaire (CFQ)(Up to 7 month)
- Use of health services, self-help methods, sleep medication,fatigue, morningness-eveningness type, and complementary and alternative medicine/treatment(Up to 7 month)
- State-Trait Anxiety Inventory (STAI)(Up to 7 month)
- Beck's Depression Inventory (BDI-II)(Up to 7 month)
- SF-12(Up to 7 month)
- Pain (questionnaire)(Up to 7 month)
- Sleep habits and sleep-relevant lifestyle(Up to 7 month)