Effects of Nurse-Led Brief Behavioral Treatment for Insomnia Following Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Sleep parameters ("change" is being assessed)
研究概览
简要总结
The current study aims to compare face-to-face and internet-based nurse-led BBTI compare to a wait-list conditions in the stroke population. This study is a parallel, three-arm, randomized controlled trial (RCT). Each participant will be randomized into one of the treatment arms; face-to-face BBTI, internet-based BBTI, and waiting-list. The BBTI, emphasizes behavioral aspects of insomnia care, arises from techniques of sleep restriction and stimulus control. The face-to-face and internet-based BBTI have equivalent content based on the standard portion. All participants will be asked to fill the online questionnaires at weeks 0 (baseline), 1 (mid-treatment), 2 (post-treatment), 4, and 12 (follow up). After the final follow-up, the waiting-list participants will be allowed to join the internet-based BBTI treatment. Our hypotheses are that patients with stroke who receive face-to-face or internet-based BBTI, compared to a wait-list condition, will experience fewer insomnia complaints.
详细描述
Post-stroke insomnia is a common complaint with prevalence rates remain high. Patients suffering from insomnia following stroke could impair their health-related quality of life and negative rehabilitation outcomes. Identifying effective treatment in managing post-stroke insomnia has become clinically relevant.
Brief behavioral therapy for insomnia (BBTI), a 4-section of treatment for insomnia, has similar treatment components with CBTI, with the exception of cognitive therapy. Previous evidence found that both BBTI and CBTI have comparable effects on improving sleep quality and consolidation. Existing literature has suggested that BBTI was effective on mitigating primary and comorbid insomnia. Nonetheless, thus far, no study has explored its effects in stroke population. Of note, BBTI still requires certain contact with therapists. To enhance the widespread dissemination of BBTI, it is important to establish the internet-based BBTI treatment model (more flexible time schedule) to target more populations with insomnia. The recent study of the online tailored BBTI has proven the comparable effects to reduce insomnia severity in the general population. However, no study investigates the efficacy of internet-based nurse-led BBTI in the stroke population.
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)
盲法说明
During the trial, the data collector will be blinded to the random assignment.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had diagnosed with stroke for at least 3 months (chronic phase)
- •Had NIHSS score < 6
- •Complain insomnia symptom based on the score of ISI> 7
- •Having sufficient cognitive function to complete tasks,
- •Able to access to internet
排除标准
- •The people receiving BBTI and other psychological treatment for insomnia
- •Doing shift work
- •Having psychiatric disorders
- •Being pregnant or breastfeeding
- •Having other sleep disorders (e.g., sleep apnea)
- •Drugs or alcohol abuse,
- •Serious or unstable medical condition prior to the study
结局指标
主要结局
Sleep parameters ("change" is being assessed)
时间窗: Baseline and up to week 4 (immediately after the intervention)
The Sleep Diary (SD) will be used to measure the subjective sleep parameters, including total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, and sleep quality. The good result such as total sleep time between 6-8 hours, sleep onset latency less than 30 minutes, wake after sleep onset less than 30 minutes, sleep efficiency greater than 85%, and sleep quality is good.
Insomnia severity ("change" is being assessed)
时间窗: Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).
Insomnia Severity Index (ISI) will be used to measure the concept of insomnia symptoms. The total score is 0-28, where cutoff point score\> 7 indicated as the presence of insomnia. The higher scores indicate severe condition.
次要结局
- Depression ("change" is being assessed)(Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).)
- Anxiety ("change" is being assessed)(Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).)
- Fatigue ("change" is being assessed)(Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).)
- Sleepiness ("change" is being assessed)(Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).)
研究者
Hsiao-Yean Chiu
Principal Investigator
Taipei Medical University