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NCT Number: NCT06073990

Brief Behavioral Therapy for Insomnia(BBTi) in Middle-aged and Older Adults With Chronic Insomnia

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Insomnia Behavior Dyssomnias Health Behavior Mental Disorders Nervous System Diseases Older Adults Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan, Taiwan, 704

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Behavioral Treatment for Insomnia (BBTI)

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. Stress index (ms2) (T1)

    Time frame: 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.

  22. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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