The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults
The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults: A Randomized Controlled Trial
- Insomnia
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Taipei Medical University
- Enrolment target
- 60
- Started
- 31 August 2026
- Main results due
- 31 July 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 65 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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 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.
Study sites(1)
Taipei Medical University / Taipei Medical University Hospital
Taipei, Taiwan
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07842250. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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