iCANSleep: A Randomized Controlled Trial of a Smartphone App-Based Insomnia Treatment for Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Insomnia Severity
研究概览
简要总结
The investigators will answer the question of whether treating insomnia using the mobile-app-based intervention of Cognitive Behavioural Therapy for Insomnia (CBT-I) for cancer survivors ("iCANSleep") can improve symptoms of insomnia in Canadian cancer survivors compared to a waitlist control group. The investigators will recruit 146 people with insomnia who have completed cancer treatment at least 3 months prior to the study.
详细描述
The investigators will conduct a randomized controlled trial of immediate treatment with the CBT-I app "iCANSleep" compared to a delayed treatment group with 146 cancer survivors who have completed primary treatment at least 3 months prior and meet DSM diagnostic criteria for insomnia. Participants who are randomized to the immediate treatment group will complete the 7-modules of the CBT-I treatment right away. Those randomized to the delayed treatment group will begin the intervention following an 8-week waiting period. The treatment group will complete assessments at baseline, mid-treatment, post-treatment, and 3-month follow-up. The delayed treatment group will complete an assessment at baseline, halfway through their wait at 4 weeks, and prior to beginning treatment at 8 weeks. They will also complete assessments at mid-treatment, post-treatment and 3-month follow-up. Insomnia severity will be analyzed using the Insomnia Severity Index (ISI) as the primary outcome. Other measures will include fatigue, anxiety, depression, pain, work productivity, sleep beliefs, daytime impact of insomnia, and pre-sleep arousal.
The investigators hypothesize that the immediate treatment group will report significantly greater improvements in insomnia compared to the waitlist control group at post-treatment (primary endpoint). The investigators also hypothesize that these improvements will be maintained at 3-months follow-up (secondary endpoint).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer survivors
- •Over 18 years of age
- •Lives in Canada
- •Understands English or French fluently
- •DSM-5 diagnosis of insomnia
- •ISI score of 8 or higher
- •Good performance status as indicated by a score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
- •Access to internet connection
- •Ownership of smartphone
- •Fluency using mobile applications.
- •Individuals with non-hematological malignancies must show no evidence of cancer or clinically stable/inactive disease for a minimum of 3 months prior to enrollment (for individuals with non-metastatic cancer) or be on a stable treatment regimen for the prior 3 months (for individuals with metastatic cancer) to ensure that insomnia is not a direct, acute response to cancer treatment.
- •Individuals with hematological malignancies must be in remission at the time of recruitment and have completed cancer treatments (e.g., transplant, chemotherapy, immunotherapy, radiotherapy) at least 3 months prior.
排除标准
- •Presence of a sleep disorder other than insomnia that is not adequately treated (e.g., untreated sleep apnea)
- •Presence of a psychological disorder that is currently untreated or would impair the ability to participate (e.g., bipolar disorder)
- •Major sensory deficit (e.g., blindness)
- •Previous experience receiving CBT-I.
- •The use of medications prescribed for sleep (e.g., hypnotics, sedatives, or antidepressants) will be tracked and adjusted for in the statistical analysis.
研究组 & 干预措施
Immediate Treatment
The immediate treatment group will begin the app-based insomnia intervention immediately after enrolling.
干预措施: App-Based Cognitive Behavioural Therapy for Insomnia (Behavioral)
Waitlist Control
The waitlist control group will begin the app-based intervention after a waiting period of 8 weeks after enrolling.
干预措施: App-Based Cognitive Behavioural Therapy for Insomnia (Behavioral)
结局指标
主要结局
Insomnia Severity
时间窗: From enrollment until 3-month follow-up
Insomnia Severity Index (Min: 0, Max: 28; Higher scores = worse outcomes)
Sleep Efficiency
时间窗: From enrollment to end of treatment at 7 weeks
Sleep efficiency measured by the Consensus Sleep Diary
Sleep-Onset Latency
时间窗: From enrollment to end of treatment at 7 weeks
Sleep-onset latency measured by the Consensus Sleep Diary
Total Sleep Time
时间窗: From enrollment to end of treatment at 7 weeks
Total sleep time measured by the Consensys Sleep Diary
Wake After Sleep Onset
时间窗: From enrollment to end of treatment at 7 weeks
Wake after sleep onset measured by the Consensus Sleep Diary
次要结局
- Fatigue(From enrollment to 3-month follow-up)
- Anxiety(From enrollment to 3-month follow-up)
- Depression(From enrollment to 3-month follow-up)
- Pain Level(From enrollment to 3-month follow-up)
- Cognitive Function(From enrollment to 3-month follow-up)
- Work Productivity and Activity Impairment(From enrollment to 3-month follow-up)
- App Engagement(From time of starting the app to completing treatment (7 weeks))
- Adverse Events(From enrollment to 3-month follow-up)
- Sleep-Related Beliefs(From enrollment to 3-month follow-up)
- Pre-Sleep Arousal(From enrollment to 3-month follow-up)
- Sleep Metrics(During 8-week waiting period for waitlist control group and from treatment end (7 weeks) to 3-month follow up)
- Daytime Impact of Insomnia(From enrollment to 3-month follow-up)
- Smartphone Self-Efficacy(Baseline)
研究者
Sheila Garland
Associate Professor of Psychology and Oncology at Memorial University of Newfoundland
Memorial University of Newfoundland