An interventional study of Brief Behavioral Treatment for Insomnia (BBTi) in Chronic Insomnia, Older Adults and Sleep Hygiene, sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment
This study aims to investigate whether a nurse-led brief behavioral therapy can effectively improve chronic insomnia and sleep health in older adults.
This study is a parallel-arm, single-site randomized controlled trial designed to evaluate the effectiveness of a nurse-led four-week Brief Behavioral Therapy for Insomnia (BBTi) program in improving insomnia symptoms, multidimensional sleep health, and mood among older adults with insomnia. Participants will be recruited from patients referred by sleep specialists for sleep education and consultation at a tertiary medical center. Eligible participants will be randomized in a 1:1 ratio to either the BBTi intervention group or a waiting-list control group using permuted block randomization with a fixed block size of four.
Inclusion criteria are: (1) age 50 years or older; (2) ability to communicate in Chinese or Mandarin; (3) no cognitive impairment, defined as a General Practitioner Assessment of Cognition (GPCOG) score ≥5; and (4) self-reported insomnia for at least three months, operationalized as an Insomnia Severity Index (ISI) score ≥8 and at least one of the following sleep complaints: mean sleep onset latency >30 minutes, mean wake after sleep onset >30 minutes, or mean total sleep time \<6.5 hours. Participants will be excluded if they have a major neurological disorder, severe psychiatric condition, or sleep apnea diagnosed by overnight polysomnography or home sleep apnea testing.
The BBTi intervention will be delivered over four weeks by a certified sleep nurse specialist. The intervention includes two in-person sessions in Weeks 1 and 3 and two structured telephone contacts in Weeks 2 and 4. The four-week format was selected because BBTi is designed as a brief, structured behavioral intervention that condenses the core components of cognitive behavioral therapy for insomnia into a clinically feasible format. The intervention targets behavioral and conditioned factors that perpetuate insomnia, including insufficient sleep drive, conditioned arousal, maladaptive sleep habits, and pre-sleep arousal.
In Week 1, participants in the BBTi group will receive an in-person baseline assessment, sleep diary review, individualized sleep hygiene education, and introduction to stimulus control principles. Stimulus control instructions include maintaining a consistent rise time, using the bed primarily for sleep, going to bed only when sleepy, leaving the bed if unable to sleep, returning to bed only when sleepy, and avoiding daytime naps when possible. In Week 2, a structured telephone contact will be conducted to review sleep diary data, reinforce sleep hygiene and stimulus control recommendations, address implementation barriers, and introduce relaxation strategies such as breathing exercises or progressive muscle relaxation. In Week 3, participants will receive an in-person reassessment and core BBTi components, including sleep restriction and time-in-bed titration based on the previous week's average total sleep time. Written sleep schedules and troubleshooting guidance will be provided. In Week 4, a final telephone contact will focus on adherence, residual barriers, consolidation of behavioral strategies, and overall review of progress.
Participants assigned to the waiting-list control group will continue usual care and will not receive structured sleep education, sleep restriction, stimulus control instructions, relaxation training, or individualized behavioral sleep guidance during the four-week study period. They will complete the same assessments as the intervention group at all scheduled time points. After completion of the final assessment, participants in the waiting-list control group will be offered the BBTi intervention.
Outcomes will be assessed at four time points: baseline before intervention initiation (T0), during Weeks 2 and 3 of the intervention (T1-T2), and one week after completion of the final intervention session (T3). Primary and secondary outcomes include insomnia severity measured by the Insomnia Severity Index, multidimensional sleep health measured by the RU-SATED Sleep Health Scale, mood symptoms measured by the Hospital Anxiety and Depression Scale, and sleep diary-derived parameters including total sleep time, sleep efficiency, sleep onset latency, and nocturnal awakenings.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 42 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →National Cheng-Kung University Hospital is the lead sponsor of 277 studies on the registry; 70 are open to participants now.
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Participants are eligible if they meet all of the following criteria:
Self-reported insomnia for at least 3 months, operationalized as an Insomnia Severity Index (ISI) score ≥8 and at least one of the following:
Exclusion Criteria
Participants are excluded if they meet any of the following criteria:
Participants in the BBTi arm will receive a nurse-led four-week Brief Behavioral Therapy for Insomnia intervention, including in-person sessions in Weeks 1 and 3 and structured telephone contacts in Weeks 2 and 4. The intervention includes individualized sleep hygiene education, stimulus control, sleep restriction/time-in-bed titration based on sleep diary data, relaxation training, and adherence review. The program is delivered by a certified sleep nurse specialist using a structured protocol.
Behavioral: Brief Behavioral Treatment for Insomnia (BBTi)
Participants assigned to the waiting-list control group will continue their usual care and will not receive structured sleep education, sleep restriction, stimulus control instructions, relaxation training, or individualized behavioral sleep guidance during the four-week study period. They will complete the same assessments as the BBTi group at all scheduled time points. After completion of the final assessment, participants in the waiting-list control group will be offered the BBTi intervention.
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.
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.
Time frame: the first week
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.
Time frame: the second week
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.
Time frame: the third week
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.
Time frame: the fourth week
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.
Time frame: the first week
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.
Time frame: the second week
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.
Time frame: the third week
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.
Time frame: the fourth week
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)
Time frame: the first week
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)
Time frame: the second week
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)
Time frame: the third week
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)
Time frame: the fourth week
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.
Time frame: the first week
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.
Time frame: the second week
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.
Time frame: the third week
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.
Time frame: the fourth week
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.
Time frame: the first week
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.
Time frame: the second week
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.
Time frame: the third week
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.
Time frame: the fourth week
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in Dec 2025, 29 months.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 29 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
Completion moved twice since we started tracking on Sep 25, 2026: Jul 2026 → Dec 2025, last on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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