InsomniaNCT05310136
Nurse-led BBTI for Improving Insomnia Severity
A study testing BBTi in people with Insomnia, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Brief behavioral treatment for insomnia (BBTI) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been established in Taiwan. This study aims to establish the BBTI treatment model among insomniacs in Taiwan and to examine the immediate effects of nurse-led BBTI in… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- 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
- 1 Apr 2022to 31 Jul 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months
- Have insomnia with a total score ≥ 8 on the Chinese version of the insomnia severity index (CISI) at screening
- Be able to communicate in Mandarin Chinese
Who cannot join
- Premorbid diagnoses of seizure, other sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score > 3), psychiatric diseases, substance abuse, and alcoholism
- Shift workers
- Women who are pregnant, breastfeeding, or in the menopausal transition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nurse-led Brief Behavioral Treatment for Insomnia: A Feasibility Randomized Controlled Trial
Brief behavioral treatment for insomnia (BBTI) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been established in Taiwan. This study aims to establish the BBTI treatment model among insomniacs in Taiwan and to examine the immediate effects of nurse-led BBTI in adults with insomnia complaints. In this assessor-blinded randomized controlled trial, participants will be randomly allocated to the nurse-led BBTI experimental group, or sleep hygiene control group. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment, posttreatment, and one-month follow-up. We hypothesize that adults with insomnia complaints undergoing nurse-led BBTI will experience greater alleviations in sleep in comparison with participants in the sleep hygiene control group.
Read the detailed description
Background: Insomnia, defined as difficulty initiating and maintaining sleep such that it interferes with daytime function, is a common complaint among the general population, which in turn undermine their mood, cognitive functions, and quality of life. Brief behavioral treatment for insomnia (BBTI) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been established in Taiwan.
Purposes: To establish the BBTi treatment model among insomniacs in Taiwan and to examine the immediate effects of nurse-led BBTI in adults with insomnia complaints. We hypothesize that adults with insomnia complaints undergoing nurse-led BBTI will experience greater alleviations in sleep in comparison with participants in the sleep hygiene control group.
Methods: This assessor-blinded randomized controlled trial will employ a two-arm parallel-group design. A total of 42 adults with insomnia complaints will be randomly allocated to the nurse-led BBTI, or sleep hygiene control group in a 1:1 ratio. For the nurse-led BBTI group, all participants will experience 4-week nurse-led BBTi via 2 in person and 2 telephone sessions. The contents include sleep hygiene, stimulus control, sleep restriction, and relaxation. For the sleep hygiene control group, they will receive usual care, sleep hygiene education, and weekly LINE contacts. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment, posttreatment, and one-month follow-up. A generalized estimating equation will be used to test research hypotheses.
- Conditions
- Insomnia
- Being tested
- BBTi
- Keywords
- BBTI, adult
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBTiBehavioural
On the arrival for the baseline appointment, participants will receive workbooks which include an outline and content of BBTi, sleep diaries, and adherence record. In the end of weeks 1 and 3, nurse interventionist will meet participants to review their sleep diary data and negotiate their bedtime and wake-time schedule. During the weeks 2 and 4, participants will receive planned follow-up phone calls to assess their adherence and review progress and challenges.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-guided BBTi intervention group | Experimental | Participants will experience 4-week treatment period (2 in person and 2 via telephone). Receives: Behavioral: BBTi |
| Control group | No intervention | Participants will received sleep hygiene at the enrollment of the study and be required to maintain their usual lifestyle and medical treatment for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Measured: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Measured: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Changes in Sleep parameters from sleep logs: total sleep time(TST)
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Measured: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
Measured: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Changes in Insomnia Severity
Insomnia Severity will be measured by Chinese version Insomnia Severity Index (ISI). ISI has 7 questions to evaluate sleep difficulty. The total score range from 0-28, if score>7 is associated with insomnia. The higher score means more severe insomnia.
Measured: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Sleep quality
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The total score range from 0-21, if score>5 is associated with poor sleep. The higher score means poorer sleep quality.
Measured: At baseline, week 5 (after the intervention), and one month (follow-up)
Secondary outcomes (6)
Changes in Quality of life
Quality of life will be measured by RAND-36 Health Status Inventory. It has 36 questions to assess eight health concepts including physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Measured: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Daytime Sleepiness
Daytime Sleepiness will be measured by Epworth Sleepiness Scale (ESS). ESS has 8 questions to evaluate the condition of dozing off or falling asleep. The total score range from 0-24, if score>10 is associated with daytime sleepiness.
Measured: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Depression
Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score>9 is associated with depression. The higher score means more severe depression.
Measured: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Anxiety
Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score>7 is associated with anxiety. The higher score means more severe anxiety.
Measured: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Stress
Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score>14 is associated with anxiety. The higher score means more severe stress.
Measured: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Fatigue
Stress will be measured by Brief Fatigue Inventory- Taiwan Form (BFI- Taiwan Form). BFI- Taiwan Form has 9 questions to evaluate the state of fatigue. The score of each item range from 0-10, if score>4 is associated with fatigue. The higher score means more severe fatigue.
Measured: At baseline, week 5 (after the intervention), and one month (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Apr 2022
- Primary completion15 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310136
- Sponsor's protocol ID
- N202111028
- Status last verified
- Aug 2025
- First submitted
- 16 Mar 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasan F, Prasetya EC, Gordon CJ, Romadlon DS, Chang KM, Bartlett DJ, Lin CJ, Gautama MSN, Izzati N, Chiu HY. Effects of nurse-led, web-based brief behavioral therapy on insomnia severity in patients in the chronic stage of stroke recovery: a preliminary randomized controlled trial. J Clin Sleep Med. 2025 Dec 1;21(12):2031-2040. doi: 10.5664/jcsm.11856.
PubMed 40904277Chang KM, Lin CJ, Jan YW, Gordon CJ, Lee HC, Shih CY, Bartlett DJ, Fan YC, Chiu HY. Effects of nurse-led brief behavioral treatment for insomnia in adults: a randomized controlled trial. J Clin Sleep Med. 2024 Nov 1;20(11):1763-1772. doi: 10.5664/jcsm.11256.
PubMed 38935053
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nurse-led Brief Behavioral Treatment for Insomnia: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05310136
- Acronym / sponsor ID
- N202111028
- Conditions
- Insomnia
- Keywords
- BBTI, adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 4 Apr 2022 (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.
Brief behavioral treatment for insomnia (BBTI) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been established in Taiwan. This study aims to establish the BBTI treatment model among insomniacs in Taiwan and to examine the immediate effects of nurse-led BBTI in adults with insomnia complaints. In this assessor-blinded randomized controlled trial, participants will be randomly allocated to the nurse-led BBTI experimental group, or sleep hygiene control group. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment, posttreatment, and one-month follow-up. We hypothesize that adults with insomnia complaints undergoing nurse-led BBTI will experience greater alleviations in sleep in comparison with participants in the sleep hygiene control group.
Detailed description
Background: Insomnia, defined as difficulty initiating and maintaining sleep such that it interferes with daytime function, is a common complaint among the general population, which in turn undermine their mood, cognitive functions, and quality of life. Brief behavioral treatment for insomnia (BBTI) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been established in Taiwan.
Purposes: To establish the BBTi treatment model among insomniacs in Taiwan and to examine the immediate effects of nurse-led BBTI in adults with insomnia complaints. We hypothesize that adults with insomnia complaints undergoing nurse-led BBTI will experience greater alleviations in sleep in comparison with participants in the sleep hygiene control group.
Methods: This assessor-blinded randomized controlled trial will employ a two-arm parallel-group design. A total of 42 adults with insomnia complaints will be randomly allocated to the nurse-led BBTI, or sleep hygiene control group in a 1:1 ratio. For the nurse-led BBTI group, all participants will experience 4-week nurse-led BBTi via 2 in person and 2 telephone sessions. The contents include sleep hygiene, stimulus control, sleep restriction, and relaxation. For the sleep hygiene control group, they will receive usual care, sleep hygiene education, and weekly LINE contacts. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment, posttreatment, and one-month follow-up. A generalized estimating equation will be used to test research hypotheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-guided BBTi intervention group | Experimental | Behavioral: BBTiParticipants will experience 4-week treatment period (2 in person and 2 via telephone). |
| Control group | No intervention | –Participants will received sleep hygiene at the enrollment of the study and be required to maintain their usual lifestyle and medical treatment for 4 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months
- Have insomnia with a total score ≥ 8 on the Chinese version of the insomnia severity index (CISI) at screening
- Be able to communicate in Mandarin Chinese
Key exclusion criteria (3 listed)
- Premorbid diagnoses of seizure, other sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score > 3), psychiatric diseases, substance abuse, and alcoholism
- Shift workers
- Women who are pregnant, breastfeeding, or in the menopausal transition
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 |
|---|---|---|
| BBTiOn the arrival for the baseline appointment, participants will receive workbooks which include an outline and content of BBTi, sleep diaries, and adherence record. In the end of weeks 1 and 3, nurse interventionist will meet participants to review their sleep diary data and negotiate their bedtime and wake-time schedule. During the weeks 2 and 4, participants will receive planned follow-up phone calls to assess their adherence and review progress and challenges. | Behavioural | Nurse-guided BBTi intervention group |
Primary outcome
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
Time frame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
Time frame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: total sleep time(TST)
Time frame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
Time frame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
Changes in Insomnia Severity
Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)
Insomnia Severity will be measured by Chinese version Insomnia Severity Index (ISI). ISI has 7 questions to evaluate sleep difficulty. The total score range from 0-28, if score>7 is associated with insomnia. The higher score means more severe insomnia.
Changes in Sleep quality
Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The total score range from 0-21, if score>5 is associated with poor sleep. The higher score means poorer sleep quality.
6 secondary outcomes
Changes in Quality of life
Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Daytime Sleepiness
Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Depression
Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Anxiety
Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Stress
Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)
Changes in Fatigue
Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)
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 12 Aug 2025.
- Derived from this study: PubMed 40904277Hasan F, Prasetya EC, Gordon CJ, Romadlon DS, Chang KM, Bartlett DJ, Lin CJ, Gautama MSN, Izzati N, Chiu HY. Effects of nurse-led, web-based brief behavioral therapy on insomnia severity in patients in the chronic stage of stroke recovery: a preliminary randomized controlled trial. J Clin Sleep Med. 2025 Dec 1;21(12):2031-2040. doi: 10.5664/jcsm.11856.
- Derived from this study: PubMed 38935053Chang KM, Lin CJ, Jan YW, Gordon CJ, Lee HC, Shih CY, Bartlett DJ, Fan YC, Chiu HY. Effects of nurse-led brief behavioral treatment for insomnia in adults: a randomized controlled trial. J Clin Sleep Med. 2024 Nov 1;20(11):1763-1772. doi: 10.5664/jcsm.11256.
- Individual participant dataSharing planned: No
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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 BBTi in people with Insomnia, run by Taipei Medical University 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 3 inclusion and 3 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 12 Aug 2025. 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?
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL) (time frame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05310136, which also lists 2 linked publications.
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 12 Aug 2025.