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RECRUITING
NCT07842250
NA

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

Sponsor: Taipei Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08-31

Completion Date

2027-08-31

Last Updated

2026-09-25

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Nurse-Led Mobile BBTI

Participants in this group will receive a 4-week Brief Behavioral Therapy for Insomnia (BBTI) intervention 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.

BEHAVIORAL

Face-to-Face BBTI

Participants in this group will receive a 4-week Brief Behavioral Therapy for Insomnia (BBTI) intervention 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.

BEHAVIORAL

Sleep Education

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 throughout the study period but will not receive active behavioral components of BBTI, such as stimulus control or sleep restriction.

Locations (1)

Taipei Medical University / Taipei Medical University Hospital

Taipei, Taiwan