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NCT Number: NCT07842250

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University / Taipei Medical University Hospital

Taipei, Taiwan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Insomnia Severity Index (ISI)

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

    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.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI) Score

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

    Subjective sleep quality will be assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). The questionnaire evaluates multiple dimensions of sleep quality over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

  2. Epworth Sleepiness Scale (ESS) Score

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

    Daytime sleepiness will be assessed using the Chinese version of the Epworth Sleepiness Scale (CESS). The scale consists of 8 items assessing the likelihood of dozing in common daily situations. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness.

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

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

    Psychological symptoms will be assessed using the 21-item Depression, Anxiety and Stress Scale (DASS-21). The instrument includes three subscales assessing depression, anxiety, and stress symptoms, with higher scores indicating greater symptom severity.

  4. Change in Sleep Onset Latency (SOL)

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

    Sleep onset latency will be derived from daily sleep diaries and defined as the self-reported time from attempting to sleep to sleep onset.

  5. Change in Wake After Sleep Onset (WASO)

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

    Wake after sleep onset will be derived from daily sleep diaries and defined as the total self-reported time spent awake after initial sleep onset and before final awakening.

  6. Change in Total Sleep Time (TST)

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

    Total sleep time will be derived from daily sleep diaries and defined as the total self-reported amount of time spent asleep during the main sleep period.

  7. Change in Time in Bed (TIB)

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

    Time in bed will be derived from daily sleep diaries and defined as the interval between bedtime and getting out of bed.

  8. Change in Sleep Efficiency (SE)

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

    Sleep efficiency will be derived from daily sleep diaries and calculated as total sleep time divided by time in bed and multiplied by 100.

  9. Change in Actigraphy-Derived Total Sleep Time(TST-Actigraphy)

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

    Objective total sleep time will be assessed using a wrist-worn actigraphy device and expressed as the estimated total amount of time spent asleep.

  10. Change in Actigraphy-Derived Sleep Onset Latency(SOL-Actigraphy)

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

    Objective sleep onset latency will be assessed using a wrist-worn actigraphy device and defined as the estimated time from attempting to sleep to sleep onset.

  11. Change in Actigraphy-Derived Wake After Sleep Onset(WASO-Actigraphy)

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

    Objective wake after sleep onset will be assessed using a wrist-worn actigraphy device and defined as the estimated amount of time spent awake after initial sleep onset.

  12. Change in Actigraphy-Derived Time in Bed (TIB-Actigraphy)

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

    Time in bed (TIB) will be derived from wrist-worn actigraphy data and defined as the duration of the designated nocturnal sleep interval. TIB corresponds to the "Duration" variable in the actigraphy output and will be expressed in minutes.

  13. Change in Actigraphy-Derived Sleep Efficiency(SE-Actigraphy)

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

    Objective sleep efficiency will be assessed using a wrist-worn actigraphy device and expressed as the percentage of time in bed spent asleep.

  14. Intervention Satisfaction and Feasibility

    Time frame: Participants assigned to the nurse-led mobile BBTI group will complete after the 4-week intervention.

    Participants' satisfaction with and perceived feasibility of the intervention will be assessed using a study-specific questionnaire evaluating aspects such as ease of use, acceptability, willingness to continue using the intervention, and perceived usefulness. Higher scores indicate greater satisfaction or perceived feasibility.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Acronym: BBTI App

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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