Integrating Smart Wearable Device Into Digital Insomnia Treatment Application: Exploration of Combining Emotional and Lifestyle Records

Insomnia severity will be measured using the Insomnia Severity Index (ISI). The ISI consists of seven items, with each item rated from 0 to 4, resulting in a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity. Changes in ISI scores will be used to evaluate whether the BBTI app intervention improves participants' insomnia symptoms.

Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates subjective sleep quality and sleep-related problems. Higher scores indicate poorer sleep quality. PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score>5 is associated with poor sleep. The higher score means poorer sleep quality.

Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.

Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.

Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).

Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.

Participants' emotional state will be measured through app-based self-reports and/or standardized emotional state questionnaires. Emotional records may include daily mood, stress, anxiety, or other sleep-related psychological states. Changes in emotional state will be used to examine whether lifestyle and sleep self-monitoring through the BBTI app is associated with emotional awareness and psychological well-being.

The Profile of Mood States (POMS) is a self-administered questionnaire that measures mood through ratings of 65 emotion terms on a five-point scale.

A Total Mood Disturbance (TMD) can be calculated by adding Tension, Depression, Anger, Fatigue and Confusion scores and then subtracting the Vigour score. TMD = (Tension + Depression + Anger + Fatigue + Confusion) - Vigour.

The response rate for sleep-related lifestyle self-monitoring will be assessed using app usage records from the BBTI app. Lifestyle self-monitoring entries include meal records, caffeinated beverage intake, and exercise records. This measure will be calculated as the percentage of lifestyle self-monitoring reminders followed by at least one completed relevant entry.

Unit of Measure：Percentage of reminders followed by a completed entry (%)

Response latency for sleep-related lifestyle self-monitoring will be assessed using app usage records from the BBTI app. Lifestyle self-monitoring entries include meal records, caffeinated beverage intake, and exercise records. This measure will be calculated as the average time between the delivery of a lifestyle self-monitoring reminder and the completion of a relevant entry.

Unit of Measure：Minutes

Overall self-monitoring completion rate will be assessed using app usage records from the BBTI app. This measure will be calculated as the percentage of scheduled daily self-monitoring tasks completed by participants, including sleep, emotion, diet, and exercise entries.

Unit of Measure：Percentage of scheduled self-monitoring tasks completed (%)

The difference in overall self-monitoring completion rate between the personalized ESM reminder group and the non-personalized ESM reminder group will be assessed using app usage records from the BBTI app. Overall self-monitoring completion rate will be calculated as the percentage of scheduled self-monitoring tasks completed by participants, including sleep, emotion, diet, and exercise entries. The personalized ESM reminder group will receive reminders based on individual lifestyle patterns, while the non-personalized ESM reminder group will receive reminders at fixed times.

Unit of Measure：Difference in percentage of scheduled self-monitoring tasks completed between groups (%)

Participants' sleep-related lifestyle behaviors will be measured through app-based self-records in the BBTI app. Lifestyle records will include meal timing and perceived fullness, caffeinated beverage intake time and amount, and exercise timing and exercise amount. Changes in sleep-related lifestyle behaviors will be used to examine participants' self-monitoring patterns and changes in lifestyle behaviors during the intervention.

Participants' perceived capability, opportunity, and motivation for insomnia-related lifestyle self-monitoring will be assessed using a COM-B-based self-report questionnaire. The questionnaire will evaluate participants' perceived capability to record lifestyle behaviors, perceived opportunity to perform self-monitoring, and motivation to continue tracking sleep-related lifestyle factors. The change score will be calculated as the difference between baseline and post-intervention questionnaire scores.

Unit of Measure：Change in mean questionnaire score

Insomnia-related lifestyle knowledge, attitudes, and behaviors will be assessed using a self-report questionnaire. The questionnaire will evaluate participants' knowledge of sleep-related lifestyle factors, attitudes toward lifestyle self-monitoring and behavior change, and self-reported lifestyle behaviors related to insomnia management. The change score will be calculated as the difference between baseline and post-intervention questionnaire scores.

Unit of Measure：Change in mean questionnaire score

The BSRS-5 asks patients to reflect on the past week (including the assessment day) and rate their level of distress or discomfort. A total score of ≤3 indicates low suicide risk. It uses a 5-point Likert scale and contains 6 items.

The WHO-5 measures subjective mental well-being and quality of life over the past two weeks using 5 items on a 6-point Likert scale.

Scoring: Raw scores range from 0-25, with higher scores indicating better well-being. Multiply the raw score by 4 to obtain a percentage score (0-100).

Interpretation: Further assessment for major depression (ICD-10) is recommended if the raw score is below 13 or if any item is rated 0 or 1.

The RSME measures the level of mental effort experienced while performing a task. Scores range from 0 to 150, with higher scores indicating greater mental effort.

Average sleep score will be assessed using sleep data collected by a smartwatch. This measure will be calculated as the average nightly sleep score during the intervention period.

Unit of Measure：Sleep score

Average daily step count will be assessed using physical activity data collected by a smartwatch. This measure will be calculated as the average number of steps per day during the intervention period.

Unit of Measure：Steps per day

Average active energy expenditure will be assessed using physical activity data collected by a smartwatch. This measure will be calculated as the average active energy expenditure per day during the intervention period.

Unit of Measure：Kilocalories per day

Average heart rate will be assessed using physiological data collected by a smartwatch. This measure will be calculated as the average heart rate during the intervention period.

Unit of Measure：Beats per minute

Average heart rate variability will be assessed using physiological data collected by a smartwatch. This measure will be calculated as the average heart rate variability during the intervention period.

Unit of Measure：Milliseconds

System usability will be assessed using the System Usability Scale after the 4-week intervention. The scale will evaluate participants' subjective perceptions of system usability, learnability, and overall satisfaction with the BBTI app and self-monitoring system.

Unit of Measure：System Usability Scale score

Participants' user experience of the BBTI app will be assessed using the User Experience Questionnaire (UEQ). The questionnaire will evaluate participants' perceptions of the app across user experience dimensions, such as attractiveness, perspicuity, efficiency, dependability, stimulation, and novelty. The UEQ score will be used to assess participants' subjective experience of using the BBTI app and smartwatch-supported lifestyle self-monitoring system.

Unit of Measure：UEQ mean scale score

Cognitive load during usability testing will be assessed using the NASA Task Load Index (NASA-TLX). Participants will complete the NASA-TLX after operating the prototype. The scale will assess perceived workload, including mental demand, physical demand, temporal demand, performance, effort, and frustration.

Unit of Measure：NASA-TLX score

Attention level during prototype operation will be assessed using an electroencephalography device during usability testing. The measure will be calculated based on the attention index or attention-related EEG indicator recorded while participants operate the prototype.

Heart rate variability during usability testing will be assessed using physiological data collected while participants operate the prototype. This measure will be calculated as the average heart rate variability during prototype operation.

Unit of Measure：Milliseconds

Insight formation ability will be assessed during usability testing based on participants' responses while reviewing lifestyle data visualizations. The analysis will refer to North's insight-based evaluation approach to evaluate the degree to which participants generate meaningful insights from lifestyle data charts.

Unit of Measure：Insight formation score