A Theory-based Sleep Hygiene Education for Insomnia Patients
Developing a Theory-based Sleep Hygiene Education Intervention for Insomnia Patients - A Mixed Method Study
Insomnia is a prevalent sleep disorder associated with substantial negative health consequences, including fatigue, irritability, and impaired daytime functioning. Although effective pharmacological and psychological treatments exist, fewer than half of individuals with insomnia seek professional treatment, highlighting the need for accessible and acceptable non-pharmacological interventions. Sleep hygiene education (SHE) has the potential to address this gap due to its simplicity, low cost, and ease of self-administration. However, previous studies have often underestimated the efficacy of SHE by using it as a passive control condition rather than an active, structured intervention. To address this limitation, the proposed pilot study aims to evaluate the feasibility and effectiveness of a theory-based, structured SHE program integrated with behavior change techniques.
研究概览
详细说明
Insomnia is a prevalent sleep disorder associated with substantial negative health consequences, including fatigue, irritability, and impaired daytime functioning. Although effective pharmacological (e.g., hypnotics) and psychological treatments (e.g., cognitive behavioral therapy for insomnia, CBT-I) are available, both local and international surveys indicate that fewer than 50% of individuals with insomnia seek treatment. This treatment gap highlights the need to develop effective non-pharmacological interventions that are both accessible and acceptable to individuals with insomnia.
Sleep hygiene education (SHE) represents a potentially suitable intervention to address this unmet need. SHE is an educational approach that encompasses a range of lifestyle and environmental recommendations aimed at optimizing sleep quality and duration, such as maintaining a regular sleep-wake schedule, avoiding substances (e.g., caffeine, nicotine, and alcohol) and daytime napping, limiting stimulating bedtime activities, creating an optimal bedroom environment, and adopting appropriate diet and exercise habits etc. Given its simplicity, low cost, accessibility, and ease of delivery and mastery, SHE holds promise as a non-pharmacological strategy for insomnia management.
Despite these advantages, SHE is not typically recommended as a stand-alone treatment for sleep-vulnerable populations, as it is often perceived to be less effective than CBT-I or mindfulness-based therapies. Notably, the efficacy of SHE may be underestimated. In many prior studies, SHE has been used primarily as a passive control condition to account for nonspecific treatment effects, resulting in its active therapeutic components being largely overlooked.
Advancing SHE beyond a simple advice-giving modality to a structured, theory-informed intervention may enhance its effectiveness by ensuring that its content is not only informative but also practicable and behaviorally achievable. Integrating SHE with evidence-based behavior change techniques may further equip participants with the skills necessary to initiate and sustain meaningful behavioral change. Accordingly, this pilot study aims to examine the feasibility and preliminary effectiveness of a theory-based SHE program previously developed by our team.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hong Kong、香港
- School of Nursing, The Hong Kong Polytechnic University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Hong Kong residents
- Ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua
- Fulfilled the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire. The criteria included having difficulties falling asleep, staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months
- Scored at least 10 points in the Insomnia Severity Index (ISI)
- Willing to give informed consent
Exclusion Criteria:
- Any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV
- Other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment
- Any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia
- Taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders
- Impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions
- Pregnant
- Shift work
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Sleep Hygiene Education
Participants in this group will receive a structured six-week SHE intervention. The intervention includes two weekly 2 hours group-based, face-to-face educational sessions (total 4 hours) conducted in a classroom at the School of Nursing, The Hong Kong Polytechnic University, followed by four weekly individualized telephone consultations lasting approximately 10 minutes each. During the educational sessions, participants will receive education on insomnia and evidence-based sleep hygiene practices and will develop individualized behavior change plans to support sustained sleep hygiene implementation. The subsequent telephone consultations will reinforce adherence to these plans through review of progress, discussion of barriers, and provision of tailored feedback. To obtain qualitative feedback on the acceptability of the intervention, a focus group interview lasting approximately 1 hour will be conducted after completion of the second educational session. |
Participants in this group will receive a structured six-week SHE intervention. The intervention includes two weekly 2 hours group-based, face-to-face educational sessions (total 4 hours) conducted in a classroom at the School of Nursing, The Hong Kong Polytechnic University, followed by four weekly individualized telephone consultations lasting approximately 10 minutes each. During the educational sessions, participants will receive education on insomnia and evidence-based sleep hygiene practices and will develop individualized behavior change plans to support sustained sleep hygiene implementation. The subsequent telephone consultations will reinforce adherence to these plans through review of progress, discussion of barriers, and provision of tailored feedback. To obtain qualitative feedback on the acceptability of the intervention, a focus group interview lasting approximately 1 hour will be conducted after completion of the second educational session.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Insomnia Severity Index (ISI)
大体时间：Baseline, week 6
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The Insomnia Severity Index has 7 items that measured the severity of insomnia complaints and related daytime impairments. The total score ranges between 0 and 28, with the higher scores indicating more severe insomnia. Total score will be used. |
Baseline, week 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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A 7-day Subjective Sleep Diary
大体时间：7-day before baseline and 6 week.
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The subjects will be asked to record their daily sleeping-waking schedule using a standard sleep diary for 7 days, and Sleep parameters, such as sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), and sleep duration (TST) will be measured. |
7-day before baseline and 6 week.
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Course Evaluation Form
大体时间：Week 2
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Participants will be asked to complete a course evaluation form after completing the two SHE sessions. The evaluation consists of five domains comprising a total of 28 items, each rated on a 5-point Likert scale. Total scores range from 28 to 140, with higher scores indicating greater satisfaction with the course content and educational materials. |
Week 2
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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