Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances
17 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Fen He Lin, Ph.D. candidate
- Telefonnummer: +886 955 092 848
- E-post: smallbox0955092848@gmail.com
Studera Kontakt Backup
- Namn: Jung Chen Chang, Ph.D.
- Telefonnummer: 288905 886-2-23123456
- E-post: jungchenchang@ntu.edu.tw
Studieorter
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-
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Taipei, Taiwan
- Public classrooms, meeting rooms, or community activity centers
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Kontakt:
- Fen He Lin, Ph.D. candidate
- Telefonnummer: +886 955 092 848
- E-post: smallbox0955092848@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Sleep and health diary
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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User acceptance and satisfaction with the chatbot-assisted intervention
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 januari 2027
Studieregistreringsdatum
Först inskickad
7 maj 2026
Först inskickad som uppfyllde QC-kriterierna
17 maj 2026
Första postat (Faktisk)
22 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 202603048RINE
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