The Effect of Nurse-Led Mobile APP-based Brief Behavioral Therapy for Insomnia in Older Adults
ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorTaipei Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse-Led Mobile BBTI
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Nurse-Led Mobile BBTIExperimental treatment 1 intervention
Group B: Face-to-Face BBTIActive comparator 1 intervention
Group C: Sleep EducationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and immediately after the 4-week intervention and 1-month follow upSecondary outcomes
1
Pittsburgh Sleep Quality Index (PSQI) Score
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.
Time frame
Baseline and immediately after the 4-week intervention and 1-month follow up2
Epworth Sleepiness Scale (ESS) Score
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.
Time frame
Baseline and immediately after the 4-week intervention and 1-month follow up3
Depression, Anxiety and Stress Scale-21 (DASS-21) Scores
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.
Time frame
Baseline and immediately after the 4-week intervention and 1-month follow up4
Change in Sleep Onset Latency (SOL)
Sleep onset latency will be derived from daily sleep diaries and defined as the self-reported time from attempting to sleep to sleep onset.
Time frame
Baseline and during the 4-week intervention period and 1-month follow upSponsors and contacts
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Source ClinicalTrials.gov