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

Older Adults Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073990
• Other study ID #: A-ER-112-175
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: National Cheng-Kung University Hospital
• Contact: Yen-Chin Chen
• Phone: +886-6-2353535
• Email: yenchin2427[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Older Adults
• Sleep Hygiene
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Brief Behavioral Treatment for Insomnia (BBTi)
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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the first week
Primary	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.	the second week
Primary	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.	the third week
Primary	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.	the fourth week
Primary	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.	the first week
Primary	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.	the second week
Primary	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.	the third week
Primary	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.	the fourth week
Primary	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)	the first week
Primary	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)	the second week
Primary	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)	the third week
Primary	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)	the fourth week
Primary	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.	the first week
Primary	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.	the second week
Primary	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.	the third week
Primary	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.	the fourth week
Primary	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.	the first week
Primary	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.	the second week
Primary	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.	the third week
Primary	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.	the fourth week
Primary	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.	the first week
Primary	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.	the third week