Programa Online de intervenção Cognitivo-Comportamental Para o Tratamento da Insónia em Sobreviventes Oncológicos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Insomnia severity
研究概览
简要总结
The main purpose of this study is to determine the treatment effects, feasibility, and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.
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 (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
- 否
入选标准
- •Age 18+ years
- •Provided informed consent
- •Ability to read and write in Portuguese
- •Ability to use a computer and/or smartphone, and the internet
- •History of cancer
- •Have completed primary cancer treatment (survivors who are on hormone and/or other long-term maintenance therapy agencies are eligible to participate)
- •Subclinical or significant symptoms of insomnia (ISI scores>8)
- •Ongoing sleep medication accepted if the dosage has been stable during the last 3 months
- •No participation in any other interventional study or clinical trial
排除标准
- •Age ≤ 18 years
- •Absence of clinically or subclinical significant symptoms
- •No history of cancer
- •Inability to provide informed consent
- •Inability to use a computer and/or smartphone
- •No access to the internet
- •Another untreated sleep diagnosis
- •Current major psychiatric or medical condition
- •Pregnancy or breastfeeding
- •Parallel ongoing psychological treatment for insomnia
- •Habitual night shift, or rotating shift-workers
研究组 & 干预措施
OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)
Participants assigned to the experimental group receive immediate access to the OncoSleep program, a web-based self-guided cognitive-behavioral intervention for insomnia consisting of 6 weekly sessions. A certified psychologist will monitor the participant's progress and provide feedback.
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
waitlist control
Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks.
结局指标
主要结局
Insomnia severity
时间窗: Changes from baseline to post-intervention (8 weeks after randomization)
Insomnia Severity Index: validated questionnaire among cancer survivors; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
次要结局
- Anxiety(Changes from baseline to post-intervention (8 weeks after randomization))
- Depression(Changes from baseline to post-intervention (8 weeks after randomization))
- Health-related quality of life(Changes from baseline to post-intervention (8 weeks after randomization))
- Cancer-related fatigue(Changes from baseline to post-intervention (8 weeks after randomization))
- Sleep efficiency(Changes from baseline to post-intervention (8 weeks after randomization))
- Total sleep time(Changes from baseline to post-intervention (8 weeks after randomization))
- Sleep onset latency(Changes from baseline to post-intervention (8 weeks after randomization))
- Number of nocturnal awakenings(Changes from baseline to post-intervention (8 weeks after randomization))
- Wake after sleep onset(Changes from baseline to post-intervention (8 weeks after randomization))
研究者
Maria Inês Clara
PhD fellowship at Center for Research in Neuropsychology and Cognitive and Behavioral Intervention
University of Coimbra