- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06073990
Brief Behavioral Therapy for Insomnia(BBTi) in Middle-aged and Older Adults With Chronic Insomnia
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yen-Chin Chen
- Phone Number: 2019 +886-6-2353535
- Email: yenchin2427@gmail.com
Study Locations
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Tainan City, Taiwan, 704
- Recruiting
- National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
-
Contact:
- YenChin Chen
- Phone Number: 2019 +886-6-2353535
- Email: yenchin2427@gmail.com
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- individuals aged 40 years and above,
- experiencing sleep disturbances,
- willing to participate in the research project and provide informed consent
Exclusion Criteria:
●Cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia severity (T1)
Time Frame: 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. |
the first week
|
Insomnia severity (T2)
Time Frame: 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. |
the second week
|
Insomnia severity (T3)
Time Frame: 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. |
the third week
|
Insomnia severity (T4)
Time Frame: 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. |
the fourth week
|
Sleep health (T1)
Time Frame: 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. |
the first week
|
Sleep health (T2)
Time Frame: 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. |
the second week
|
Sleep health (T3)
Time Frame: 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. |
the third week
|
Sleep health (T4)
Time Frame: 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. |
the fourth week
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Sleep Diary_Sleep efficacy (%) (T1)
Time Frame: 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) |
the first week
|
Sleep Diary_Sleep efficacy (%) (T2)
Time Frame: 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) |
the second week
|
Sleep Diary_Sleep efficacy (%) (T3)
Time Frame: 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) |
the third week
|
Sleep Diary_Sleep efficacy (%) (T4)
Time Frame: 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) |
the fourth week
|
Anxiety (T1)
Time Frame: 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. |
the first week
|
Anxiety (T2)
Time Frame: 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. |
the second week
|
Anxiety (T3)
Time Frame: 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. |
the third week
|
Anxiety (T4)
Time Frame: 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. |
the fourth week
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Depression (T1)
Time Frame: 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. |
the first week
|
Depression (T2)
Time Frame: 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. |
the second week
|
Depression (T3)
Time Frame: 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. |
the third week
|
Depression (T4)
Time Frame: 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. |
the fourth week
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Stress index (ms2) (T1)
Time Frame: the first week
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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. |
the first week
|
Stress index (ms2) (T3)
Time Frame: 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. |
the third week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-ER-112-175
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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