InsomniaBBTI AppNCT07842250
The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults
A study testing Nurse-Led Mobile BBTI, Face-to-Face BBTI and Sleep Education in people with Insomnia, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Background: Insomnia affects 20%-30% of older adults and is linked to increased fall risk, cognitive decline, and cardiovascular disease. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, its length and limited workforce restrict implementation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Nurse-Led Mobile BBTI, Face-to-Face BBTI and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older.
- An Insomnia Severity Index (ISI) score of 15 or higher, with the presence of insomnia-related symptoms such as difficulty initiating sleep, frequent nocturnal awakenings, or early morning awakening.
- Conscious and able to understand the study information.
- Ownership of a smartphone.
- Ability to operate the application and complete online questionnaires independently or with assistance from research staff or family.
Who cannot join
- Presence of severe psychiatric disorders with an unstable clinical condition.
- Diagnosed or suspected moderate to severe obstructive sleep apnea that has not been treated.
- Adjustment of sleep-related medication dosage within the past four weeks.
- Engagement in shift work or night work.
- Participants with acute cardiopulmonary diseases.
- Participants reporting a pain intensity score of ≥ 5 (on a 0-10 numeric rating scale) that interferes with sleep.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University / Taipei Medical University Hospital
Taipei
YuFang Chang, +886-906-821-933, m432114001@tmu.edu.tw
About this study
Official title: The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults: A Randomized Controlled Trial
Background: Insomnia affects 20%-30% of older adults and is linked to increased fall risk, cognitive decline, and cardiovascular disease. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, its length and limited workforce restrict implementation. Brief Behavioral Treatment for Insomnia (BBTI), a four-week intervention, offers a simplified alternative. However, digital-only approaches may be challenging for older adults, making nurse-supported digital BBTI a potential solution.
Objective and Methods: This study evaluates the effectiveness of a nurse-guided, app-based BBTI. A three-arm randomized controlled trial will recruit 60 adults aged ≥65 with ISI ≥15, assigned to a nurse-guided app group, face-to-face treatment, or sleep education. The app group receives a four-week intervention with nurse follow-up. The face-to-face treatment group received weekly nurse-delivered BBTI for four weeks, while the sleep education group received a sleep education booklet.
Evaluation: The primary outcome is ISI, with secondary measures including PSQI, ESS, DASS-21, wearable sleep data, and user satisfaction. Data will be analyzed using LMM. This study is expected to improve treatment accessibility and support evidence-based insomnia care for older adults.
- Conditions
- Insomnia
- Being tested
- Nurse-Led Mobile BBTI, Face-to-Face BBTI, Sleep Education
- 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.
Nurse-Led Mobile BBTIBehavioural
Participants in this group will receive a 4-week Brief Behavioral Therapy for Insomnia (BBTI) intervention delivered through a mobile application with nurse guidance. The intervention includes sleep diary monitoring, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, sleep education, and individualized feedback based on participants' sleep patterns. Nurses will provide regular guidance and follow-up throughout the intervention period.
Face-to-Face BBTIBehavioural
Participants in this group will receive a 4-week Brief Behavioral Therapy for Insomnia (BBTI) intervention delivered by a trained nurse. The intervention includes sleep diary review, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, and sleep education. Four sessions will be provided during the intervention period, including in-person sessions and telephone follow-up, with individualized adjustment of behavioral recommendations according to participants' sleep patterns.
Sleep EducationBehavioural
Participants in this group will receive sleep education during the 4-week study period. Educational materials will provide general information about sleep, healthy sleep habits, and factors that may affect sleep. Participants will receive regular follow-up throughout the study period but will not receive active behavioral components of BBTI, such as stimulus control or sleep restriction.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Mobile BBTI | Experimental | Participants in this group will receive a 4-week brief behavioral treatment for insomnia (BBTI) delivered through a mobile application with nurse guidance. The intervention includes sleep diary monitoring, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, sleep education, and individualized feedback based on participants' sleep patterns. Nurses will provide regular guidance and follow-up throughout the intervention period. Receives: Behavioral: Nurse-Led Mobile BBTI |
| Face-to-Face BBTI | Active comparator | Participants in this group will receive a 4-week brief behavioral treatment for insomnia (BBTI) delivered by a trained nurse. The intervention includes sleep diary review, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, and sleep education. Four sessions will be provided during the intervention period, including in-person sessions and telephone follow-up, with individualized adjustment of behavioral recommendations according to participants' sleep patterns. Receives: Behavioral: Face-to-Face BBTI |
| Sleep Education | Active comparator | Participants in this group will receive sleep education during the 4-week study period. Educational materials will provide general information about sleep, healthy sleep habits, and factors that may affect sleep. Participants will receive regular follow-up during the study period but will not receive active behavioral components of BBTI, such as stimulus control or sleep restriction. Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Insomnia severity will be assessed using the Chinese version of the Insomnia Severity Index (C-ISI). The ISI consists of 7 items assessing the severity and impact of insomnia symptoms. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: Baseline and immediately after the 4-week intervention and 1-month follow up
Secondary outcomes (14)
Pittsburgh Sleep Quality Index (PSQI) Score
Subjective sleep quality will be assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). The questionnaire evaluates multiple dimensions of sleep quality over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline and immediately after the 4-week intervention and 1-month follow up
Epworth Sleepiness Scale (ESS) Score
Daytime sleepiness will be assessed using the Chinese version of the Epworth Sleepiness Scale (CESS). The scale consists of 8 items assessing the likelihood of dozing in common daily situations. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness.
Measured: Baseline and immediately after the 4-week intervention and 1-month follow up
Depression, Anxiety and Stress Scale-21 (DASS-21) Scores
Psychological symptoms will be assessed using the 21-item Depression, Anxiety and Stress Scale (DASS-21). The instrument includes three subscales assessing depression, anxiety, and stress symptoms, with higher scores indicating greater symptom severity.
Measured: Baseline and immediately after the 4-week intervention and 1-month follow up
Change in Sleep Onset Latency (SOL)
Sleep onset latency will be derived from daily sleep diaries and defined as the self-reported time from attempting to sleep to sleep onset.
Measured: Baseline and during the 4-week intervention period and 1-month follow up
Change in Wake After Sleep Onset (WASO)
Wake after sleep onset will be derived from daily sleep diaries and defined as the total self-reported time spent awake after initial sleep onset and before final awakening.
Measured: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Total Sleep Time (TST)
Total sleep time will be derived from daily sleep diaries and defined as the total self-reported amount of time spent asleep during the main sleep period.
Measured: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Time in Bed (TIB)
Time in bed will be derived from daily sleep diaries and defined as the interval between bedtime and getting out of bed.
Measured: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Sleep Efficiency (SE)
Sleep efficiency will be derived from daily sleep diaries and calculated as total sleep time divided by time in bed and multiplied by 100.
Measured: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Actigraphy-Derived Total Sleep Time(TST-Actigraphy)
Objective total sleep time will be assessed using a wrist-worn actigraphy device and expressed as the estimated total amount of time spent asleep.
Measured: Baseline and during the 4-week intervention period and 1-month follow up
Change in Actigraphy-Derived Sleep Onset Latency(SOL-Actigraphy)
Objective sleep onset latency will be assessed using a wrist-worn actigraphy device and defined as the estimated time from attempting to sleep to sleep onset.
Measured: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Actigraphy-Derived Wake After Sleep Onset(WASO-Actigraphy)
Objective wake after sleep onset will be assessed using a wrist-worn actigraphy device and defined as the estimated amount of time spent awake after initial sleep onset.
Measured: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Actigraphy-Derived Time in Bed (TIB-Actigraphy)
Time in bed (TIB) will be derived from wrist-worn actigraphy data and defined as the duration of the designated nocturnal sleep interval. TIB corresponds to the "Duration" variable in the actigraphy output and will be expressed in minutes.
Measured: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Actigraphy-Derived Sleep Efficiency(SE-Actigraphy)
Objective sleep efficiency will be assessed using a wrist-worn actigraphy device and expressed as the percentage of time in bed spent asleep.
Measured: Baseline, during the 4-week intervention, and 1-month follow-up.
Intervention Satisfaction and Feasibility
Participants' satisfaction with and perceived feasibility of the intervention will be assessed using a study-specific questionnaire evaluating aspects such as ease of use, acceptability, willingness to continue using the intervention, and perceived usefulness. Higher scores indicate greater satisfaction or perceived feasibility.
Measured: Participants assigned to the nurse-led mobile BBTI group will complete after the 4-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start31 Aug 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842250
- Sponsor's protocol ID
- N202605137
- Acronym
- BBTI App
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07842250
- Acronym / sponsor ID
- BBTI App / N202605137
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 25 Sep 2026 (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.
Background: Insomnia affects 20%-30% of older adults and is linked to increased fall risk, cognitive decline, and cardiovascular disease. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, its length and limited workforce restrict implementation. Brief Behavioral Treatment for Insomnia (BBTI), a four-week intervention, offers a simplified alternative. However, digital-only approaches may be challenging for older adults, making nurse-supported digital BBTI a potential solution.
Objective and Methods: This study evaluates the effectiveness of a nurse-guided, app-based BBTI. A three-arm randomized controlled trial will recruit 60 adults aged ≥65 with ISI ≥15, assigned to a nurse-guided app group, face-to-face treatment, or sleep education. The app group receives a four-week intervention with nurse follow-up. The face-to-face treatment group received weekly nurse-delivered BBTI for four weeks, while the sleep education group received a sleep education booklet.
Evaluation: The primary outcome is ISI, with secondary measures including PSQI, ESS, DASS-21, wearable sleep data, and user satisfaction. Data will be analyzed using LMM. This study is expected to improve treatment accessibility and support evidence-based insomnia care for older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Mobile BBTI | Experimental | Behavioral: Nurse-Led Mobile BBTIParticipants in this group will receive a 4-week brief behavioral treatment for insomnia (BBTI) delivered through a mobile application with nurse guidance. The intervention includes sleep diary monitoring, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, sleep education, and individualized feedback based on participants' sleep patterns. Nurses will provide regular guidance and follow-up throughout the intervention period. |
| Face-to-Face BBTI | Active comparator | Behavioral: Face-to-Face BBTIParticipants in this group will receive a 4-week brief behavioral treatment for insomnia (BBTI) delivered by a trained nurse. The intervention includes sleep diary review, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, and sleep education. Four sessions will be provided during the intervention period, including in-person sessions and telephone follow-up, with individualized adjustment of behavioral recommendations according to participants' sleep patterns. |
| Sleep Education | Active comparator | Behavioral: Sleep EducationParticipants in this group will receive sleep education during the 4-week study period. Educational materials will provide general information about sleep, healthy sleep habits, and factors that may affect sleep. Participants will receive regular follow-up during the study period but will not receive active behavioral components of BBTI, such as stimulus control or sleep restriction. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged 65 years or older.
- An Insomnia Severity Index (ISI) score of 15 or higher, with the presence of insomnia-related symptoms such as difficulty initiating sleep, frequent nocturnal awakenings, or early morning awakening.
- Conscious and able to understand the study information.
- Ownership of a smartphone.
- Ability to operate the application and complete online questionnaires independently or with assistance from research staff or family.
Key exclusion criteria (6 listed)
- Presence of severe psychiatric disorders with an unstable clinical condition.
- Diagnosed or suspected moderate to severe obstructive sleep apnea that has not been treated.
- Adjustment of sleep-related medication dosage within the past four weeks.
- Engagement in shift work or night work.
- Participants with acute cardiopulmonary diseases.
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 |
|---|---|---|
| Nurse-Led Mobile BBTIParticipants in this group will receive a 4-week Brief Behavioral Therapy for Insomnia (BBTI) intervention delivered through a mobile application with nurse guidance. The intervention includes sleep diary monitoring, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, sleep education, and individualized feedback based on participants' sleep patterns. Nurses will provide regular guidance and follow-up throughout the intervention period. | Behavioural | Nurse-Led Mobile BBTI |
| Face-to-Face BBTIParticipants in this group will receive a 4-week Brief Behavioral Therapy for Insomnia (BBTI) intervention delivered by a trained nurse. The intervention includes sleep diary review, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, and sleep education. Four sessions will be provided during the intervention period, including in-person sessions and telephone follow-up, with individualized adjustment of behavioral recommendations according to participants' sleep patterns. | Behavioural | Face-to-Face BBTI |
| Sleep EducationParticipants in this group will receive sleep education during the 4-week study period. Educational materials will provide general information about sleep, healthy sleep habits, and factors that may affect sleep. Participants will receive regular follow-up throughout the study period but will not receive active behavioral components of BBTI, such as stimulus control or sleep restriction. | Behavioural | Sleep Education |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline and immediately after the 4-week intervention and 1-month follow up
Insomnia severity will be assessed using the Chinese version of the Insomnia Severity Index (C-ISI). The ISI consists of 7 items assessing the severity and impact of insomnia symptoms. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity.
14 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline and immediately after the 4-week intervention and 1-month follow up
Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline and immediately after the 4-week intervention and 1-month follow up
Depression, Anxiety and Stress Scale-21 (DASS-21) Scores
Time frame: Baseline and immediately after the 4-week intervention and 1-month follow up
Change in Sleep Onset Latency (SOL)
Time frame: Baseline and during the 4-week intervention period and 1-month follow up
Change in Wake After Sleep Onset (WASO)
Time frame: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Total Sleep Time (TST)
Time frame: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Time in Bed (TIB)
Time frame: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Sleep Efficiency (SE)
Time frame: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Actigraphy-Derived Total Sleep Time(TST-Actigraphy)
Time frame: Baseline and during the 4-week intervention period and 1-month follow up
Change in Actigraphy-Derived Sleep Onset Latency(SOL-Actigraphy)
Time frame: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Actigraphy-Derived Wake After Sleep Onset(WASO-Actigraphy)
Time frame: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Actigraphy-Derived Time in Bed (TIB-Actigraphy)
Time frame: Baseline, during the 4-week intervention, and 1-month follow-up.
Change in Actigraphy-Derived Sleep Efficiency(SE-Actigraphy)
Time frame: Baseline, during the 4-week intervention, and 1-month follow-up.
Intervention Satisfaction and Feasibility
Time frame: Participants assigned to the nurse-led mobile BBTI group will complete after the 4-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Mobile BBTI, Face-to-Face BBTI and Sleep Education 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YuFang Chang (+886-906-821-933, m432114001@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Baseline and immediately after the 4-week intervention and 1-month follow up). 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 25 Sep 2026.