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

NCT07842250 | Recruiting

• 1 other identifier: N202605137
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  Insomnia severity will be assessed using the Chinese version of the Insomnia Severity Index (C-ISI). The ISI consists of 7 items assessing the severity and impact of insomnia symptoms. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity.

  Baseline and immediately after the 4-week intervention and 1-month follow up

Secondary Outcomes (14)

• Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline and immediately after the 4-week intervention and 1-month follow up

• Epworth Sleepiness Scale (ESS) Score

  Baseline and immediately after the 4-week intervention and 1-month follow up

• Depression, Anxiety and Stress Scale-21 (DASS-21) Scores

  Baseline and immediately after the 4-week intervention and 1-month follow up

• Change in Sleep Onset Latency (SOL)

  Baseline and during the 4-week intervention period and 1-month follow up

• Change in Wake After Sleep Onset (WASO)

  Baseline, during the 4-week intervention, and 1-month follow-up.

Study Arms (3)

Nurse-Led Mobile BBTI

EXPERIMENTAL

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.

Behavioral: Nurse-Led Mobile BBTI

Face-to-Face BBTI

ACTIVE COMPARATOR

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.

Behavioral: Face-to-Face BBTI

Sleep Education

ACTIVE COMPARATOR

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.

Behavioral: Sleep Education

Interventions

Nurse-Led Mobile BBTI BEHAVIORAL

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.

Nurse-Led Mobile BBTI

Face-to-Face BBTI BEHAVIORAL

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.

Face-to-Face BBTI

Sleep Education BEHAVIORAL

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.

Sleep Education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University / Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

YuFang Chang

CONTACT

+886-906-821-933; m432114001@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 25, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

TW (1)