A Quasi-experimental Study Design of Evaluation the Effects of Brief Behavioral Therapy for Insomnia on Regulating Stress and Sleep Quality in Middle-aged and Older Adults With Chronic Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sleep health (T1)
研究概览
简要总结
This study aims to investigate whether a four-week BBTi program can effectively improve chronic insomnia and reduce overall stress in middle-aged and elderly individuals.
详细描述
This study will be conducted a single-group pre-test and post-test design, aiming to recruit 80 subjects who will undergo a four-week BBTi intervention. Participants will be selected from sleep counseling patients referred by sleep specialists. Inclusion criteria include: 1) individuals aged 40 years and above; 2) experiencing sleep disturbances; 3) willing to participate in the research project and provide informed consent. Cognitive impairment will exclude. The intervention consists of four weeks of BBTi. During the first week, participants will receive face-to-face sleep assessments and sleep hygiene education. In the second week, a phone interview will be conducted to assess the patient's progress and provide appropriate relaxation techniques. Unsatisfactory responses to sleep restriction therapy or stimulation control methods will be addressed through face-to-face interviews in the third week. The fourth week will involve an overall review and evaluation conducted via a telephone interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals aged 40 years and above,
- •experiencing sleep disturbances,
- •willing to participate in the research project and provide informed consent
排除标准
- •●Cognitive impairment
研究组 & 干预措施
Brief Behavioral Treatment for Insomnia (BBTi)
In the post-intervention group, the investigators collected data at the 1-week, 2-week, and 3-week marks following the intervention.
干预措施: Brief Behavioral Treatment for Insomnia (BBTi) (Behavioral)
结局指标
主要结局
Sleep health (T1)
时间窗: the first week
The researchers collected data using the Regulatory Satisfaction Alertness Timing Efficiency Duration (RU-SATED) questionnaire from the participants. The RU-SATED questionnaire consists of six questions, each evaluating distinct facets of sleep health. These questions encompass aspects such as sleep regularity, sleep satisfaction, daytime alertness, sleep timing, sleep efficiency, and sleep duration. Each question is rated on a scale of 0 to 2 points, resulting in a total score that ranges from 0 to 12 points. A higher total score across these six questions indicates a greater level of sleep health.
Sleep health (T3)
时间窗: the third week
The researchers collected data using the Regulatory Satisfaction Alertness Timing Efficiency Duration (RU-SATED) questionnaire from the participants. The RU-SATED questionnaire consists of six questions, each evaluating distinct facets of sleep health. These questions encompass aspects such as sleep regularity, sleep satisfaction, daytime alertness, sleep timing, sleep efficiency, and sleep duration. Each question is rated on a scale of 0 to 2 points, resulting in a total score that ranges from 0 to 12 points. A higher total score across these six questions indicates a greater level of sleep health.
Sleep Diary_Sleep efficacy (%) (T1)
时间窗: the first week
The researchers obtained sleep diaries from the participants. The sleep diary is a subjective record in which subjects document their sleep patterns. The following aspects can be assessed through the sleep diary: Total Sleep Time (TST):Calculated as the time elapsed from the moment of waking to the time of falling asleep. Sleep Efficiency: The ratio of total sleep time (TST) to time in bed (TIB) (multiplied by 100 to yield a percentage)
Insomnia severity (T1)
时间窗: the first week
The investigators collected the insomnia severity from participants: The Insomnia Severity Scale (ISI) comprises seven items. Each question is scored on a scale of 0 to 4 points, and total scores are ranged 0-28 points. A higher total score indicates a higher severity of insomnia. Specifically, a score ranging from 0 to 7 indicates no significant insomnia issues, while a score of 8 to 14 signifies mild sleep difficulties. An ISI score falling within the range of 15 to 21 reflects moderate insomnia, and a score of 22 to 28 indicates severe insomnia.
Sleep Diary_Sleep efficacy (%) (T3)
时间窗: the third week
The researchers obtained sleep diaries from the participants. The sleep diary is a subjective record in which subjects document their sleep patterns. The following aspects can be assessed through the sleep diary: Total Sleep Time (TST):Calculated as the time elapsed from the moment of waking to the time of falling asleep. Sleep Efficiency: The ratio of total sleep time (TST) to time in bed (TIB) (multiplied by 100 to yield a percentage)
Sleep Diary_Sleep efficacy (%) (T2)
时间窗: the second week
The researchers obtained sleep diaries from the participants. The sleep diary is a subjective record in which subjects document their sleep patterns. The following aspects can be assessed through the sleep diary: Total Sleep Time (TST):Calculated as the time elapsed from the moment of waking to the time of falling asleep. Sleep Efficiency: The ratio of total sleep time (TST) to time in bed (TIB) (multiplied by 100 to yield a percentage)
Depression (T1)
时间窗: the first week
The researchers collected data using the Hospital Anxiety and Depression Scale (HADS) from the participants. This scale, originally developed by Zigmond and Snaith in 1983, was designed for individuals with physical illnesses. It consists of a total of 14 items, each scored on a four-point scale (ranging from 0 to 3 points). The scale comprises 7 items related to anxiety and 7 items related to depression. Interpretation of the scores is as follows: A total score of less than 8 indicates the absence of depression. A score falling between 8 and 10 suggests possible depression. A score exceeding 11 indicates the presence of depression in the patient.
Insomnia severity (T2)
时间窗: the second week
The investigators collected the insomnia severity from participants: The Insomnia Severity Scale (ISI) comprises seven items. Each question is scored on a scale of 0 to 4 points, and total scores are ranged 0-28 points. A higher total score indicates a higher severity of insomnia. Specifically, a score ranging from 0 to 7 indicates no significant insomnia issues, while a score of 8 to 14 signifies mild sleep difficulties. An ISI score falling within the range of 15 to 21 reflects moderate insomnia, and a score of 22 to 28 indicates severe insomnia.
Insomnia severity (T3)
时间窗: the third week
The investigators collected the insomnia severity from participants: The Insomnia Severity Scale (ISI) comprises seven items. Each question is scored on a scale of 0 to 4 points, and total scores are ranged 0-28 points. A higher total score indicates a higher severity of insomnia. Specifically, a score ranging from 0 to 7 indicates no significant insomnia issues, while a score of 8 to 14 signifies mild sleep difficulties. An ISI score falling within the range of 15 to 21 reflects moderate insomnia, and a score of 22 to 28 indicates severe insomnia.
Insomnia severity (T4)
时间窗: the fourth week
The investigators collected the insomnia severity from participants: The Insomnia Severity Scale (ISI) comprises seven items. Each question is scored on a scale of 0 to 4 points, and total scores are ranged 0-28 points. A higher total score indicates a higher severity of insomnia. Specifically, a score ranging from 0 to 7 indicates no significant insomnia issues, while a score of 8 to 14 signifies mild sleep difficulties. An ISI score falling within the range of 15 to 21 reflects moderate insomnia, and a score of 22 to 28 indicates severe insomnia.
Sleep health (T2)
时间窗: the second week
The researchers collected data using the Regulatory Satisfaction Alertness Timing Efficiency Duration (RU-SATED) questionnaire from the participants. The RU-SATED questionnaire consists of six questions, each evaluating distinct facets of sleep health. These questions encompass aspects such as sleep regularity, sleep satisfaction, daytime alertness, sleep timing, sleep efficiency, and sleep duration. Each question is rated on a scale of 0 to 2 points, resulting in a total score that ranges from 0 to 12 points. A higher total score across these six questions indicates a greater level of sleep health.
Anxiety (T2)
时间窗: the second week
The researchers collected data using the Hospital Anxiety and Depression Scale (HADS) from the participants. This scale, originally developed by Zigmond and Snaith in 1983, was designed for individuals with physical illnesses. It consists of a total of 14 items, each scored on a four-point scale (ranging from 0 to 3 points). The scale comprises 7 items related to anxiety and 7 items related to depression. Interpretation of the scores is as follows: A total score of less than 8 indicates the absence of anxiety. A score falling between 8 and 10 suggests possible anxiety. A score exceeding 11 indicates the presence of anxiety in the patient.
Sleep health (T4)
时间窗: the fourth week
The researchers collected data using the Regulatory Satisfaction Alertness Timing Efficiency Duration (RU-SATED) questionnaire from the participants. The RU-SATED questionnaire consists of six questions, each evaluating distinct facets of sleep health. These questions encompass aspects such as sleep regularity, sleep satisfaction, daytime alertness, sleep timing, sleep efficiency, and sleep duration. Each question is rated on a scale of 0 to 2 points, resulting in a total score that ranges from 0 to 12 points. A higher total score across these six questions indicates a greater level of sleep health.
Depression (T2)
时间窗: the second week
The researchers collected data using the Hospital Anxiety and Depression Scale (HADS) from the participants. This scale, originally developed by Zigmond and Snaith in 1983, was designed for individuals with physical illnesses. It consists of a total of 14 items, each scored on a four-point scale (ranging from 0 to 3 points). The scale comprises 7 items related to anxiety and 7 items related to depression. Interpretation of the scores is as follows: A total score of less than 8 indicates the absence of depression. A score falling between 8 and 10 suggests possible depression. A score exceeding 11 indicates the presence of depression in the patient.
Depression (T4)
时间窗: the fourth week
The researchers collected data using the Hospital Anxiety and Depression Scale (HADS) from the participants. This scale, originally developed by Zigmond and Snaith in 1983, was designed for individuals with physical illnesses. It consists of a total of 14 items, each scored on a four-point scale (ranging from 0 to 3 points). The scale comprises 7 items related to anxiety and 7 items related to depression. Interpretation of the scores is as follows: A total score of less than 8 indicates the absence of depression. A score falling between 8 and 10 suggests possible depression. A score exceeding 11 indicates the presence of depression in the patient.
Anxiety (T1)
时间窗: the first week
The researchers collected data using the Hospital Anxiety and Depression Scale (HADS) from the participants. This scale, originally developed by Zigmond and Snaith in 1983, was designed for individuals with physical illnesses. It consists of a total of 14 items, each scored on a four-point scale (ranging from 0 to 3 points). The scale comprises 7 items related to anxiety and 7 items related to depression. Interpretation of the scores is as follows: A total score of less than 8 indicates the absence of anxiety. A score falling between 8 and 10 suggests possible anxiety. A score exceeding 11 indicates the presence of anxiety in the patient.
Depression (T3)
时间窗: the third week
The researchers collected data using the Hospital Anxiety and Depression Scale (HADS) from the participants. This scale, originally developed by Zigmond and Snaith in 1983, was designed for individuals with physical illnesses. It consists of a total of 14 items, each scored on a four-point scale (ranging from 0 to 3 points). The scale comprises 7 items related to anxiety and 7 items related to depression. Interpretation of the scores is as follows: A total score of less than 8 indicates the absence of depression. A score falling between 8 and 10 suggests possible depression. A score exceeding 11 indicates the presence of depression in the patient.
Sleep Diary_Sleep efficacy (%) (T4)
时间窗: the fourth week
The researchers obtained sleep diaries from the participants. The sleep diary is a subjective record in which subjects document their sleep patterns. The following aspects can be assessed through the sleep diary: Total Sleep Time (TST):Calculated as the time elapsed from the moment of waking to the time of falling asleep. Sleep Efficiency: The ratio of total sleep time (TST) to time in bed (TIB) (multiplied by 100 to yield a percentage)
Anxiety (T3)
时间窗: the third week
The researchers collected data using the Hospital Anxiety and Depression Scale (HADS) from the participants. This scale, originally developed by Zigmond and Snaith in 1983, was designed for individuals with physical illnesses. It consists of a total of 14 items, each scored on a four-point scale (ranging from 0 to 3 points). The scale comprises 7 items related to anxiety and 7 items related to depression. Interpretation of the scores is as follows: A total score of less than 8 indicates the absence of anxiety. A score falling between 8 and 10 suggests possible anxiety. A score exceeding 11 indicates the presence of anxiety in the patient.
Anxiety (T4)
时间窗: the fourth week
The researchers collected data using the Hospital Anxiety and Depression Scale (HADS) from the participants. This scale, originally developed by Zigmond and Snaith in 1983, was designed for individuals with physical illnesses. It consists of a total of 14 items, each scored on a four-point scale (ranging from 0 to 3 points). The scale comprises 7 items related to anxiety and 7 items related to depression. Interpretation of the scores is as follows: A total score of less than 8 indicates the absence of anxiety. A score falling between 8 and 10 suggests possible anxiety. A score exceeding 11 indicates the presence of anxiety in the patient.
Stress index (ms2) (T1)
时间窗: the first week
The investigators use EUREKA to detect the heartbeat variation of participants and analyze the pressure index. Stress index (ms2) \< 50: abnormal records; 50-150: Normal; 150-500: fatigue state or greater physical and mental stress; 500-900: severe physical and mental stress; \> 900 extreme physical and mental stress or other physical diseases.
Stress index (ms2) (T3)
时间窗: the third week
The investigators use EUREKA to detect the heartbeat variation of participants and analyze the pressure index. Stress index (ms2) \< 50: abnormal records; 50-150: Normal; 150-500: fatigue state or greater physical and mental stress; 500-900: severe physical and mental stress; \> 900 extreme physical and mental stress or other physical diseases.
次要结局
未报告次要终点
研究者
Chen, Yen-Chin
Vice Head Nurse and Clinical Assistant Professor
National Cheng-Kung University Hospital
