Effects of Nurse-led Brief Behavioral Treatment for Insomnia: A Feasibility 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
- Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
研究概览
简要总结
Brief behavioral treatment for insomnia (BBTI) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been established in Taiwan. This study aims to establish the BBTI treatment model among insomniacs in Taiwan and to examine the immediate effects of nurse-led BBTI in adults with insomnia complaints. In this assessor-blinded randomized controlled trial, participants will be randomly allocated to the nurse-led BBTI experimental group, or sleep hygiene control group. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment, posttreatment, and one-month follow-up. We hypothesize that adults with insomnia complaints undergoing nurse-led BBTI will experience greater alleviations in sleep in comparison with participants in the sleep hygiene control group.
详细描述
Background: Insomnia, defined as difficulty initiating and maintaining sleep such that it interferes with daytime function, is a common complaint among the general population, which in turn undermine their mood, cognitive functions, and quality of life. Brief behavioral treatment for insomnia (BBTI) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been established in Taiwan.
Purposes: To establish the BBTi treatment model among insomniacs in Taiwan and to examine the immediate effects of nurse-led BBTI in adults with insomnia complaints. We hypothesize that adults with insomnia complaints undergoing nurse-led BBTI will experience greater alleviations in sleep in comparison with participants in the sleep hygiene control group.
Methods: This assessor-blinded randomized controlled trial will employ a two-arm parallel-group design. A total of 42 adults with insomnia complaints will be randomly allocated to the nurse-led BBTI, or sleep hygiene control group in a 1:1 ratio. For the nurse-led BBTI group, all participants will experience 4-week nurse-led BBTi via 2 in person and 2 telephone sessions. The contents include sleep hygiene, stimulus control, sleep restriction, and relaxation. For the sleep hygiene control group, they will receive usual care, sleep hygiene education, and weekly LINE contacts. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment, posttreatment, and one-month follow-up. A generalized estimating equation will be used to test research hypotheses.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months
- •Have insomnia with a total score ≥ 8 on the Chinese version of the insomnia severity index (CISI) at screening
- •Be able to communicate in Mandarin Chinese
排除标准
- •Premorbid diagnoses of seizure, other sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score > 3), psychiatric diseases, substance abuse, and alcoholism
- •Shift workers
- •Women who are pregnant, breastfeeding, or in the menopausal transition
结局指标
主要结局
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
时间窗: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
时间窗: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
时间窗: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: total sleep time(TST)
时间窗: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Changes in Insomnia Severity
时间窗: At baseline, week 5 (after the intervention), and one month (follow-up)
Insomnia Severity will be measured by Chinese version Insomnia Severity Index (ISI). ISI has 7 questions to evaluate sleep difficulty. The total score range from 0-28, if score\>7 is associated with insomnia. The higher score means more severe insomnia.
Changes in Sleep quality
时间窗: At baseline, week 5 (after the intervention), and one month (follow-up)
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The total score range from 0-21, if score\>5 is associated with poor sleep. The higher score means poorer sleep quality.
次要结局
- Changes in Anxiety(At baseline, week 5 (after the intervention), and one month (follow-up))
- Changes in Quality of life(At baseline, week 5 (after the intervention), and one month (follow-up))
- Changes in Depression(At baseline, week 5 (after the intervention), and one month (follow-up))
- Changes in Stress(At baseline, week 5 (after the intervention), and one month (follow-up))
- Changes in Daytime Sleepiness(At baseline, week 5 (after the intervention), and one month (follow-up))
- Changes in Fatigue(At baseline, week 5 (after the intervention), and one month (follow-up))
研究者
Hsiao-Yean Chiu
Principal Investigator
Taipei Medical University