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The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults

RecruitingNAAges 65 Years - anyAllTaipei Medical University
NCT07842250 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Presence of severe psychiatric disorders with an unstable clinical condition. * Diagnosed or suspected moderate to severe obstructive sleep apnea that has not been treated. * Adjustment of sleep-related medication dosage within the past four weeks. * Engagement in shift work or night work. * Participants with acute cardiopulmonary diseases. * Participants reporting a pain intensity score of ≥ 5 (on a 0-10 numeric rating scale) that interferes with sleep.
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What it tests

  • Nurse-Led Mobile BBTI
  • Face-to-Face BBTI
  • Sleep Education
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Where

1 site
Taipei Medical University / Taipei Medical University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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