Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances
17 mei 2026 bijgewerkt door: National Taiwan University Hospital
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Fen He Lin, Ph.D. candidate
- Telefoonnummer: +886 955 092 848
- E-mail: smallbox0955092848@gmail.com
Studie Contact Back-up
- Naam: Jung Chen Chang, Ph.D.
- Telefoonnummer: 288905 886-2-23123456
- E-mail: jungchenchang@ntu.edu.tw
Studie Locaties
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Taipei, Taiwan
- Public classrooms, meeting rooms, or community activity centers
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Contact:
- Fen He Lin, Ph.D. candidate
- Telefoonnummer: +886 955 092 848
- E-mail: smallbox0955092848@gmail.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Receiving BBT-I intervention combined with a chatbot support
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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.
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Geen tussenkomst: Self-monitoring control group
Participants are only required to self-monitor their sleep patterns and join a chatbot group for contact.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sleep and health diary
Tijdsspanne: Daily self-recording during one month intervention period
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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.
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Daily self-recording during one month intervention period
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Insomnia Severity Index
Tijdsspanne: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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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.
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Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Pittsburgh Sleep Quality Index
Tijdsspanne: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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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.
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Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Patient Health Questionnaire 9-item
Tijdsspanne: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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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.
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Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Generalized Anxiety Disorder 7 Item
Tijdsspanne: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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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.
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Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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User acceptance and satisfaction with the chatbot-assisted intervention
Tijdsspanne: After four weeks intervention
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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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After four weeks intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juni 2026
Primaire voltooiing (Geschat)
1 december 2026
Studie voltooiing (Geschat)
1 januari 2027
Studieregistratiedata
Eerst ingediend
7 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 mei 2026
Eerst geplaatst (Werkelijk)
22 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
17 mei 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 202603048RINE
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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