The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults
A legfontosabb adatok
- Ki végzi
- Taipei Medical University
- Hol
- Tajvan1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 60 fő, tervezett
- Kezdés
- 2026. aug. 31.
- Várható befejezés
- 2027. aug. 31.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Nurse-Led Mobile BBTI
- Face-to-Face BBTI
- Sleep Education
- A regiszteradat frissítve
- 2026. szeptember 25.
Ki vehet részt
- Életkor
- 65 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 11 feltétel megnézéseKevesebb
Ki vehet részt
- Aged 65 years or older
- An Insomnia Severity Index (ISI) score of 15 or higher, with the presence of insomnia-related symptoms such as difficulty initiating sleep, frequent nocturnal awakenings, or early morning awakening
- Conscious and able to understand the study information
- Ownership of a smartphone
- Ability to operate the application and complete online questionnaires independently or with assistance from research staff or family
Ki nem vehet részt
- Adjustment of sleep-related medication dosage within the past four weeks
- Presence of severe psychiatric disorders with an unstable clinical condition
- Participants with acute cardiopulmonary diseases
- Diagnosed or suspected moderate to severe obstructive sleep apnea that has not been treated
- Engagement in shift work or night work
- Participants reporting a pain intensity score of ≥ 5 (on a 0-10 numeric rating scale) that interferes with sleep
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
Background: Insomnia affects 20%-30% of older adults and is linked to increased fall risk, cognitive decline, and cardiovascular disease. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, its length and limited workforce restrict implementation. Brief Behavioral Treatment for Insomnia (BBTI), a four-week intervention, offers a simplified alternative. However, digital-only approaches may be challenging for older adults, making nurse-supported digital BBTI a potential solution.
A teljes eredeti leírásKevesebb
Objective and Methods: This study evaluates the effectiveness of a nurse-guided, app-based BBTI. A three-arm randomized controlled trial will recruit 60 adults aged ≥65 with ISI ≥15, assigned to a nurse-guided app group, face-to-face treatment, or sleep education. The app group receives a four-week intervention with nurse follow-up. The face-to-face treatment group received weekly nurse-delivered BBTI for four weeks, while the sleep education group received a sleep education booklet.
Evaluation: The primary outcome is ISI, with secondary measures including PSQI, ESS, DASS-21, wearable sleep data, and user satisfaction. Data will be analyzed using LMM. This study is expected to improve treatment accessibility and support evidence-based insomnia care for older adults.
A vizsgálat 3 csoportja
- Nurse-Led Mobile BBTIA vizsgált kezelés
Participants in this group will receive a 4-week brief behavioral treatment for insomnia (BBTI) delivered through a mobile application with nurse guidance. The intervention includes sleep diary monitoring, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, sleep education, and individualized feedback based on participants' sleep patterns. Nurses will provide regular guidance and follow-up throughout the intervention period.
- Face-to-Face BBTIMár használt kezelés, összehasonlításként
Participants in this group will receive a 4-week brief behavioral treatment for insomnia (BBTI) delivered by a trained nurse. The intervention includes sleep diary review, stimulus control, sleep restriction, fixed wake-time recommendations, relaxation strategies, and sleep education. Four sessions will be provided during the intervention period, including in-person sessions and telephone follow-up, with individualized adjustment of behavioral recommendations according to participants' sleep patterns.
- Sleep EducationMár használt kezelés, összehasonlításként
Participants in this group will receive sleep education during the 4-week study period. Educational materials will provide general information about sleep, healthy sleep habits, and factors that may affect sleep. Participants will receive regular follow-up during the study period but will not receive active behavioral components of BBTI, such as stimulus control or sleep restriction.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults: A Randomized Controlled Trial
- A regiszteradat frissítve
- 2026. szeptember 25.