The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
Background: Insomnia affects 20%-30% of older adults and is linked to increased fall risk, cognitive decline, and cardiovascular disease. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, its length and limited workforce restrict implementation. Brief Behavioral Treatment for Insomnia (BBTI), a four-week intervention, offers a simplified alternative. However, digital-only approaches may be challenging for older adults, making nurse-supported digital BBTI a potential solution.
Objective and Methods: This study evaluates the effectiveness of a nurse-guided, app-based BBTI. A three-arm randomized controlled trial will recruit 60 adults aged ≥65 with ISI ≥15, assigned to a nurse-guided app group, face-to-face treatment, or sleep education. The app group receives a four-week intervention with nurse follow-up. The face-to-face treatment group received weekly nurse-delivered BBTI for four weeks, while the sleep education group received a sleep education booklet.
Evaluation: The primary outcome is ISI, with secondary measures including PSQI, ESS, DASS-21, wearable sleep data, and user satisfaction. Data will be analyzed using LMM. This study is expected to improve treatment accessibility and support evidence-based insomnia care for older adults.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years or older.
- •An Insomnia Severity Index (ISI) score of 15 or higher, with the presence of insomnia-related symptoms such as difficulty initiating sleep, frequent nocturnal awakenings, or early morning awakening.
- •Conscious and able to understand the study information.
- •Ownership of a smartphone.
- •Ability to operate the application and complete online questionnaires independently or with assistance from research staff or family.
排除标准
- •Presence of severe psychiatric disorders with an unstable clinical condition.
- •Diagnosed or suspected moderate to severe obstructive sleep apnea that has not been treated.
- •Adjustment of sleep-related medication dosage within the past four weeks.
- •Engagement in shift work or night work.
- •Participants with acute cardiopulmonary diseases.
- •Participants reporting a pain intensity score of ≥ 5 (on a 0-10 numeric rating scale) that interferes with sleep.
研究组 & 干预措施
Nurse-Led Mobile BBTI
Participants in this group will receive a 4-week brief behavioral treatment for insomnia (BBTI) delivered through a mobile application with nurse guidance. The intervention includes sleep diary monitoring, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, sleep education, and individualized feedback based on participants' sleep patterns. Nurses will provide regular guidance and follow-up throughout the intervention period.
干预措施: Nurse-Led Mobile BBTI (Behavioral)
Face-to-Face BBTI
Participants in this group will receive a 4-week brief behavioral treatment for insomnia (BBTI) delivered by a trained nurse. The intervention includes sleep diary review, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, and sleep education. Four sessions will be provided during the intervention period, including in-person sessions and telephone follow-up, with individualized adjustment of behavioral recommendations according to participants' sleep patterns.
干预措施: Face-to-Face BBTI (Behavioral)
Sleep Education
Participants in this group will receive sleep education during the 4-week study period. Educational materials will provide general information about sleep, healthy sleep habits, and factors that may affect sleep. Participants will receive regular follow-up during the study period but will not receive active behavioral components of BBTI, such as stimulus control or sleep restriction.
干预措施: Sleep Education (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Baseline and immediately after the 4-week intervention and 1-month follow up
Insomnia severity will be assessed using the Chinese version of the Insomnia Severity Index (C-ISI). The ISI consists of 7 items assessing the severity and impact of insomnia symptoms. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity.
次要结局
- Pittsburgh Sleep Quality Index (PSQI) Score(Baseline and immediately after the 4-week intervention and 1-month follow up)
- Epworth Sleepiness Scale (ESS) Score(Baseline and immediately after the 4-week intervention and 1-month follow up)
- Depression, Anxiety and Stress Scale-21 (DASS-21) Scores(Baseline and immediately after the 4-week intervention and 1-month follow up)
- Change in Sleep Onset Latency (SOL)(Baseline and during the 4-week intervention period and 1-month follow up)
- Change in Wake After Sleep Onset (WASO)(Baseline, during the 4-week intervention, and 1-month follow-up.)
- Change in Total Sleep Time (TST)(Baseline, during the 4-week intervention, and 1-month follow-up.)
- Change in Time in Bed (TIB)(Baseline, during the 4-week intervention, and 1-month follow-up.)
- Change in Sleep Efficiency (SE)(Baseline, during the 4-week intervention, and 1-month follow-up.)
- Change in Actigraphy-Derived Total Sleep Time(TST-Actigraphy)(Baseline and during the 4-week intervention period and 1-month follow up)
- Change in Actigraphy-Derived Sleep Onset Latency(SOL-Actigraphy)(Baseline, during the 4-week intervention, and 1-month follow-up.)
- Change in Actigraphy-Derived Wake After Sleep Onset(WASO-Actigraphy)(Baseline, during the 4-week intervention, and 1-month follow-up.)
- Change in Actigraphy-Derived Time in Bed (TIB-Actigraphy)(Baseline, during the 4-week intervention, and 1-month follow-up.)
- Change in Actigraphy-Derived Sleep Efficiency(SE-Actigraphy)(Baseline, during the 4-week intervention, and 1-month follow-up.)
- Intervention Satisfaction and Feasibility(Participants assigned to the nurse-led mobile BBTI group will complete after the 4-week intervention.)