Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in Actigraphy indices from baseline to post-treatment
研究概览
简要总结
Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, as well as the demonstrated harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its efficacy during pregnancy. This project will investigate the efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.
详细描述
Study details are included in the publication listed here: https://www.ncbi.nlm.nih.gov/pubmed/27124405
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
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking women
- •Over the age of 18
- •Between twelve and twenty-eight weeks of gestation
- •Identify as experiencing sleep disturbances will be recruited.
排除标准
- •Women who identify as experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome, obstructive sleep apnea)
- •Women who are experiencing a current major depressive episode, or have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
- •Currently taking prescribed medications for sleep problems
- •Inability to attend at least 4 out of the 5 weekly therapy sessions, participate in the assessments
- •Smoking, drinking alcohol or drug use during pregnancy.
研究组 & 干预措施
CBT for Insomnia
Participants attend 5 weekly sessions of Cognitive Behavioural Therapy for Insomnia for pregnant women, administered by licensed clinical psychologist.
干预措施: Cognitive Behavioural Therapy for Insomnia (Other)
结局指标
主要结局
Change in Actigraphy indices from baseline to post-treatment
时间窗: Baseline (Week 1), Post-treatment (Week 7)
Actigraphy is recommended as a reliable and useful method of objective sleep assessment, providing information about indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings
Change in Sleep Diary variables from baseline to post-treatment
时间窗: Baseline (Week 1), Treatment (Weeks 2-6), Post-treatment (Week 7)
Participants complete a daily, standardized sleep diary on a weekly basis both during the treatment period, and at baseline and final assessment times to corroborate actigraphy data. Dependent variables derived from this data include total sleep time, time in bed, sleep efficiency, and sleep quality
Change in Insomnia Severity Index (ISI) scores from baseline to post-treatment
时间窗: Baseline (Week 1), Post-treatment (Week 7)
The ISI can be used to assess the severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and one's perceived distress caused by sleep problems. Scores on the ISI range from 0 to 28, with scores ≥ 15 indicating clinical insomnia.
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to post-treatment
时间窗: Baseline (Week 1), Post-treatment (Week 7)
The PSQI instrument is used in assessing one's sleep quality in the preceding month. It is comprised of 19 self-rated items and 5 questions rated by the roommate or bed partner. The PSQI possesses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. PSQI scores range from 0 to 21, with scores greater than 5 indicating poor sleep quality.
次要结局
- Change in Edinburgh Postpartum Depression Scale (EPDS) scores from baseline to post-treatment(Baseline (Week 1), Post-treatment (Week 7))
研究者
Lianne Tomfohr-Madsen
Assistant Professor of Psychology
University of Calgary