Brief Behavioral Therapy for Insomnia(BBTi) in Middle-aged and Older Adults With Chronic Insomnia
Primary Purpose
Chronic Insomnia, Older Adults, Sleep Hygiene
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Brief Behavioral Treatment for Insomnia (BBTi)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Brief Behavioral Treatment for Insomnia, Chronic Insomnia, Older adults, Sleep Hygiene
Eligibility Criteria
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
Sites / Locations
- National Cheng Kung University Hospital, College of Medicine, National Cheng Kung UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brief Behavioral Treatment for Insomnia (BBTi)
Arm Description
In the post-intervention group, the investigators collected data at the 1-week, 2-week, and 3-week marks following the intervention.
Outcomes
Primary Outcome Measures
Insomnia severity (T1)
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 (T2)
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)
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)
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 (T1)
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 (T2)
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)
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 (T4)
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)
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)
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 (%) (T3)
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 (%) (T4)
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 (T1)
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 (T2)
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 (T3)
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)
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 (T1)
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 (T2)
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 (T3)
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)
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.
Stress index (ms2) (T1)
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06073990
First Posted
August 23, 2023
Last Updated
October 5, 2023
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06073990
Brief Title
Brief Behavioral Therapy for Insomnia(BBTi) in Middle-aged and Older Adults With Chronic Insomnia
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia, Older Adults, Sleep Hygiene
Keywords
Brief Behavioral Treatment for Insomnia, Chronic Insomnia, Older adults, Sleep Hygiene
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brief Behavioral Treatment for Insomnia (BBTi)
Arm Type
Experimental
Arm Description
In the post-intervention group, the investigators collected data at the 1-week, 2-week, and 3-week marks following the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Treatment for Insomnia (BBTi)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia severity (T1)
Description
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.
Time Frame
the first week
Title
Insomnia severity (T2)
Description
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.
Time Frame
the second week
Title
Insomnia severity (T3)
Description
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.
Time Frame
the third week
Title
Insomnia severity (T4)
Description
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.
Time Frame
the fourth week
Title
Sleep health (T1)
Description
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.
Time Frame
the first week
Title
Sleep health (T2)
Description
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.
Time Frame
the second week
Title
Sleep health (T3)
Description
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.
Time Frame
the third week
Title
Sleep health (T4)
Description
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.
Time Frame
the fourth week
Title
Sleep Diary_Sleep efficacy (%) (T1)
Description
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)
Time Frame
the first week
Title
Sleep Diary_Sleep efficacy (%) (T2)
Description
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)
Time Frame
the second week
Title
Sleep Diary_Sleep efficacy (%) (T3)
Description
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)
Time Frame
the third week
Title
Sleep Diary_Sleep efficacy (%) (T4)
Description
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)
Time Frame
the fourth week
Title
Anxiety (T1)
Description
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.
Time Frame
the first week
Title
Anxiety (T2)
Description
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.
Time Frame
the second week
Title
Anxiety (T3)
Description
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.
Time Frame
the third week
Title
Anxiety (T4)
Description
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.
Time Frame
the fourth week
Title
Depression (T1)
Description
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.
Time Frame
the first week
Title
Depression (T2)
Description
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.
Time Frame
the second week
Title
Depression (T3)
Description
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.
Time Frame
the third week
Title
Depression (T4)
Description
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.
Time Frame
the fourth week
Title
Stress index (ms2) (T1)
Description
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.
Time Frame
the first week
Title
Stress index (ms2) (T3)
Description
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.
Time Frame
the third week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Chin Chen
Phone
+886-6-2353535
Ext
2019
Email
yenchin2427@gmail.com
Facility Information:
Facility Name
National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
City
Tainan City
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YenChin Chen
Phone
+886-6-2353535
Ext
2019
Email
yenchin2427@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Brief Behavioral Therapy for Insomnia(BBTi) in Middle-aged and Older Adults With Chronic Insomnia
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