Sleep DisturbanceNCT07603687
Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances
A study testing Nurse-Led Chatbot-Enhanced BBT-I in people with Sleep Disturbance and Insomnia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this interventional study is to develop a in person nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention integrated with a chatbot and evaluate its effects on sleep disturbance, anxiety, depression, and fatigue among community-dwelling adults, as well as user acceptance and satisfaction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Insomnia
- What is being tested?
- Nurse-Led Chatbot-Enhanced BBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2026to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 or older
- Self-reported have sleep disturbances, such as: difficulty falling asleep, difficulty maintaining sleep, waking up too early and being unable to fall asleep
Who cannot join
- Individuals with cognitive impairment who are unable to communicate in Mandarin or Taiwanese
- Individuals lack the ability to use smartphones to join the chatbot group
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
Public classrooms, meeting rooms, or community activity centers
Taipei
Fen He Lin, Ph.D. candidate, +886 955 092 848, smallbox0955092848@gmail.com
About this study
Official title: Effectiveness of a Nurse-led Brief Behavioral Intervention for Insomnia With Health Education Chatbot Assistance Among Community-dwelling Adults: a Randomized Controlled Trial
The goal of this interventional study is to develop a in person nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention integrated with a chatbot and evaluate its effects on sleep disturbance, anxiety, depression, and fatigue among community-dwelling adults, as well as user acceptance and satisfaction with the chatbot-assisted intervention.
Participants who meet the inclusion criteria will be randomly assigned to either an intervention group receiving BBT-I combined with a chatbot or a self-monitoring control group.
- Conditions
- Sleep Disturbance, Insomnia
- Being tested
- Nurse-Led Chatbot-Enhanced BBT-I
- Keywords
- sleep disturbance, Brief Behavioral Treatment for Insomnia
- Medical subject headings
- Parasomnias, 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 Chatbot-Enhanced BBT-IBehavioural
An in-person, nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention, supplemented by an chatbot that provides educational content and remote, two-way interactive support.
| Study group | Role | What they receive |
|---|---|---|
| Receiving BBT-I intervention combined with a chatbot support | Experimental | Not described Receives: Behavioral: Nurse-Led Chatbot-Enhanced BBT-I |
| Self-monitoring control group | No intervention | Participants are only required to self-monitor their sleep patterns and join a chatbot group for contact. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep and health diary
Daily self-recording of sleep behaviors during the intervention. Such as time in/out of bed, napping, and subjective sleep quality along with lifestyle factors like screen time, diet, and exercise, helps researchers understand subjects' actual sleep patterns and health behaviors.
Measured: Daily self-recording during one month intervention period
Insomnia Severity Index
The Insomnia Severity Scale (ISI) is a 7-item self-report scale for insomnia symptoms. Participants self-report their difficulty falling asleep, difficulty maintaining sleep, early awakening, and the severity of these symptoms' impact on daily life. Each item on the ISI is scored on a 5-point Likert scale (0-4 points), with the total score ranging from 0 to 28 points. Higher score indicates more severe insomnia.
Measured: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Scale (PSQI) was utilized to assess the level of sleep disturbances for adults. The PSQI is a 19-item self-administered questionnaire scored on a Likert scale from 0 to 3. Higher score indicates greater sleep disturbances.
Measured: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
Patient Health Questionnaire 9-item
The Patient Health Questionnaire 9-item (PHQ-9) scale contains 7 items to assess the level of depression over the past two weeks. Each item is rated on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day). The scale score range is 0 to 27. Higher score indicates more severe depression level.
Measured: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
Generalized Anxiety Disorder 7 Item
Generalized Anxiety Disorder 7 Item (GAD-7) consists of 7 questions asking about anxiety symptoms or feelings over the past two weeks. Each question is scored on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day), with a score range of 0 to 21. Higher score indicates greater level of anxiety.
Measured: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
Secondary outcomes (1)
User acceptance and satisfaction with the chatbot-assisted intervention
Based on the six dimensions of the Healthcare Information System (HIS) success model proposed by DeLone and McLean (2003), a questionnaire was designed to assess the intervention group's satisfaction with and acceptance of the education chatbot. This self-administered tool utilized a 5-point Likert scale (ranging from 1 to 5), where higher scores indicate greater acceptance and satisfaction.
Measured: After four weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603687
- Sponsor's protocol ID
- 202603048RINE
- Status last verified
- Apr 2026
- First submitted
- 7 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nurse-led Brief Behavioral Intervention for Insomnia With Health Education Chatbot Assistance Among Community-dwelling Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07603687
- Acronym / sponsor ID
- 202603048RINE
- Conditions
- Sleep Disturbance, Insomnia
- Keywords
- sleep disturbance, Brief Behavioral Treatment for Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 May 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.
The goal of this interventional study is to develop a in person nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention integrated with a chatbot and evaluate its effects on sleep disturbance, anxiety, depression, and fatigue among community-dwelling adults, as well as user acceptance and satisfaction with the chatbot-assisted intervention.
Participants who meet the inclusion criteria will be randomly assigned to either an intervention group receiving BBT-I combined with a chatbot or a self-monitoring control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving BBT-I intervention combined with a chatbot support | Experimental | Behavioral: Nurse-Led Chatbot-Enhanced BBT-I |
| Self-monitoring control group | No intervention | –Participants are only required to self-monitor their sleep patterns and join a chatbot group for contact. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 or older
- Self-reported have sleep disturbances, such as: difficulty falling asleep, difficulty maintaining sleep, waking up too early and being unable to fall asleep
Key exclusion criteria (2 listed)
- Individuals with cognitive impairment who are unable to communicate in Mandarin or Taiwanese
- Individuals lack the ability to use smartphones to join the chatbot group
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 Chatbot-Enhanced BBT-IAn in-person, nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention, supplemented by an chatbot that provides educational content and remote, two-way interactive support. | Behavioural | Receiving BBT-I intervention combined with a chatbot support |
Primary outcome
Sleep and health diary
Time frame: Daily self-recording during one month intervention period
Daily self-recording of sleep behaviors during the intervention. Such as time in/out of bed, napping, and subjective sleep quality along with lifestyle factors like screen time, diet, and exercise, helps researchers understand subjects' actual sleep patterns and health behaviors.
Insomnia Severity Index
Time frame: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
The Insomnia Severity Scale (ISI) is a 7-item self-report scale for insomnia symptoms. Participants self-report their difficulty falling asleep, difficulty maintaining sleep, early awakening, and the severity of these symptoms' impact on daily life. Each item on the ISI is scored on a 5-point Likert scale (0-4 points), with the total score ranging from 0 to 28 points. Higher score indicates more severe insomnia.
Pittsburgh Sleep Quality Index
Time frame: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
Pittsburgh Sleep Quality Scale (PSQI) was utilized to assess the level of sleep disturbances for adults. The PSQI is a 19-item self-administered questionnaire scored on a Likert scale from 0 to 3. Higher score indicates greater sleep disturbances.
Patient Health Questionnaire 9-item
Time frame: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
The Patient Health Questionnaire 9-item (PHQ-9) scale contains 7 items to assess the level of depression over the past two weeks. Each item is rated on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day). The scale score range is 0 to 27. Higher score indicates more severe depression level.
Generalized Anxiety Disorder 7 Item
Time frame: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
Generalized Anxiety Disorder 7 Item (GAD-7) consists of 7 questions asking about anxiety symptoms or feelings over the past two weeks. Each question is scored on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day), with a score range of 0 to 21. Higher score indicates greater level of anxiety.
1 secondary outcome
User acceptance and satisfaction with the chatbot-assisted intervention
Time frame: After four weeks 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 22 May 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep Disturbance
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
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 Chatbot-Enhanced BBT-I in people with Sleep Disturbance and Insomnia, run by National Taiwan 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 May 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 Fen He Lin, Ph.D. candidate (+886 955 092 848, smallbox0955092848@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep and health diary (time frame: Daily self-recording during one month intervention period). The study lists 5 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 22 May 2026.