Chronic InsomniaNCT06073990
Brief Behavioral Therapy for Insomnia (BBTi) in Middle-aged and Older Adults With Chronic Insomnia
A study testing Brief Behavioral Treatment for Insomnia (BBTi) in people with Chronic Insomnia and Older Adults, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This study aims to investigate whether a nurse-led brief behavioral therapy can effectively improve chronic insomnia and sleep health in older adults. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Insomnia, Older Adults, Sleep Hygiene
- What is being tested?
- Brief Behavioral Treatment for Insomnia (BBTi)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jul 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible if they meet all of the following criteria:
- Aged 50 years or older.
- Able to communicate in Chinese or Mandarin.
- No cognitive impairment, defined as a General Practitioner Assessment of Cognition (GPCOG) score ≥5.
- Self-reported insomnia for at least 3 months, operationalized as an Insomnia Severity Index (ISI) score ≥8 and at least one of the following:
- Mean sleep onset latency >30 minutes;
- Mean wake after sleep onset >30 minutes;
- Mean total sleep time <6.5 hours.
Who cannot join
- Participants are excluded if they meet any of the following criteria:
- Major neurological disorder.
- Severe psychiatric condition.
- Sleep apnea diagnosed by overnight polysomnography or home sleep apnea testing.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Tainan, Taiwan, 704
About this study
Official title: A Nurse-led Brief Behavioral Therapy for Insomnia Improves Multidimensional Sleep Health and Anxiety in Aging Adults: A Randomized Controlled Trial
This study aims to investigate whether a nurse-led brief behavioral therapy can effectively improve chronic insomnia and sleep health in older adults.
Read the detailed description
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.
- Conditions
- Chronic Insomnia, Older Adults, Sleep Hygiene, Sleep Health
- Being tested
- Brief Behavioral Treatment for Insomnia (BBTi)
- Keywords
- Brief Behavioral Treatment for Insomnia, Chronic Insomnia, Older adults, Sleep Hygiene, Sleep Health
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment for Insomnia (BBTi)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTi) | Experimental | 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. Receives: Behavioral: Brief Behavioral Treatment for Insomnia (BBTi) |
| Waiting-list Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: the fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start13 Jul 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Chen, Yen-Chin, National Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073990
- Sponsor's protocol ID
- A-ER-112-175
- Status last verified
- Nov 2026
- First submitted
- 23 Aug 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-led Brief Behavioral Therapy for Insomnia Improves Multidimensional Sleep Health and Anxiety in Aging Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06073990
- Acronym / sponsor ID
- A-ER-112-175
- Conditions
- Chronic Insomnia, Older Adults, Sleep Hygiene, Sleep Health
- Keywords
- Brief Behavioral Treatment for Insomnia, Chronic Insomnia, Older adults, Sleep Hygiene, Sleep Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether a nurse-led brief behavioral therapy can effectively improve chronic insomnia and sleep health in older adults.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTi) | Experimental | Behavioral: Brief Behavioral Treatment for Insomnia (BBTi)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. |
| Waiting-list Control | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 50 years or older.
- Able to communicate in Chinese or Mandarin.
- No cognitive impairment, defined as a General Practitioner Assessment of Cognition (GPCOG) score ≥5.
- Self-reported insomnia for at least 3 months, operationalized as an Insomnia Severity Index (ISI) score ≥8 and at least one of the following:
Key exclusion criteria (4 listed)
- Major neurological disorder.
- Severe psychiatric condition.
- Sleep apnea diagnosed by overnight polysomnography or home sleep apnea testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Brief Behavioral Treatment for Insomnia (BBTi) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment for Insomnia (BBTi) in people with Chronic Insomnia and Older Adults, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (T1) (time frame: the first week). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.