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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving BBT-I intervention combined with a chatbot support | Experimental |
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| Self-monitoring control group | No Intervention | Participants are only required to self-monitor their sleep patterns and join a chatbot group for contact. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-Led Chatbot-Enhanced BBT-I | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fen He Lin, Ph.D. candidate | Contact | +886 955 092 848 | smallbox0955092848@gmail.com | |
| Jung Chen Chang, Ph.D. | Contact | 886-2-23123456 | 288905 | jungchenchang@ntu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public classrooms, meeting rooms, or community activity centers | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| 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. | Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period. |
| After four weeks intervention |
| D020920 | Dyssomnias |