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Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances

17. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Taiwan
      • Taipei, Taiwan
        • Public classrooms, meeting rooms, or community activity centers
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Receiving BBT-I intervention combined with a chatbot support
Adfærdsmæssigt: Nurse-Led Chatbot-Enhanced BBT-I
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.
Ingen indgriben: Self-monitoring control group
Participants are only required to self-monitor their sleep patterns and join a chatbot group for contact.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep and health diary
Tidsramme: 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.
Daily self-recording during one month intervention period
Insomnia Severity Index
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
User acceptance and satisfaction with the chatbot-assisted intervention
Tidsramme: After four weeks 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.
After four weeks intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Taiwan University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

17. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202603048RINE

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Søvnløshed

Kliniske forsøg med Nurse-Led Chatbot-Enhanced BBT-I

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