Insomina, Mood Change
Conditions
Keywords
insomnia, bbti, Mood, Lifestyle, Digital recording,, Experience Sampling Method, Wearable Devices
Brief summary
Emotions, behavior, and cognition are the main factors contributing to insomnia. Insomnia not only affects sleep quality but also harms health, quality of life, and daytime functioning. Brief Behavioral Treatment for Insomnia (BBTI) is considered a short-term effective treatment for insomnia and has been implemented on online platforms. However, the causes of insomnia are complex, and when designing related digital products, it is essential to consider the psychological and lifestyle states of individuals with insomnia, employing a user-centered approach and interactive design. Previous research has integrated emotion tracking and an abdominal breathing game into the existing BBTI APP. This study will further incorporate the tracking of emotions and lifestyle factors (specifically diet and exercise) into a digital insomnia application, while also connecting with smartwatches and using the Experience Sampling Method (ESM) to collect data. It aims to explore the preferences of individuals with insomnia for digital tracking and examine the impact of their recorded information related to insomnia on their sleep and self-management. The ultimate goal of this study is to enhance the existing insomnia app's features, offering innovative and convenient self-monitoring methods to help therapists better understand the condition of individuals with insomnia, while improving self-awareness and self-management. The anticipated results are expected to provide design recommendations for future digital applications related to insomnia, thereby improving the digital healthcare experience and medical efficacy.
Interventions
DEVICEPersonalized Experience Sampling Method
Reminder times will be personalized based on participants' lifestyle patterns. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study.
DEVICENon-personalized Experience Sampling Method
Reminder times will be preset by the researchers. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study.
Sponsors
National Taipei University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Experimental Phase 1 Insomnia Subjects * Aged 18 to 64 years * Complaints of insomnia symptoms * Insomnia Severity Index (ISI) total score ≥ 8 * Able to express emotions and physical/mental condition normally * Able to independently complete questionnaires * Able to cooperate with wearing smart watches and EEG devices Subjects Without Insomnia * Aged 18 to 64 years * Insomnia Severity Index (ISI) total score \< 8 * Able to express emotions and physical/mental condition normally * Able to independently complete questionnaires * Able to cooperate with wearing smart watches and EEG devices Experimental Phase 2 Insomnia Subjects * Aged 18 to 64 years * Complaints of insomnia symptoms * Insomnia Severity Index (ISI) total score ≥ 8 * Able to express emotions and physical/mental condition normally * Able to independently complete questionnaires * Able to cooperate with wearing smart watches and EEG devices * Owns an iOS device capable of downloading the experimental application Subjects Without Insomnia * Aged 18 to 64 years * Insomnia Severity Index (ISI) total score \< 8 * Able to express emotions and physical/mental condition normally * Able to independently complete questionnaires * Able to cooperate with wearing smart watches and EEG devices * Owns an iOS device capable of downloading the experimental application Phase III * Aged 18 to 64 years * Complaints of insomnia symptoms (e.g., total wakefulness at night for at least 30 minutes, occurring more than 3 days per week for at least 3 months) * Insomnia Severity Index (ISI) total score ≥ 8 * Able to express emotions and physical/mental condition normally * Able to independently complete questionnaires * Able to cooperate with wearing a smart watch * Able to use the system for recording over a four-week period
Exclusion criteria
* Previously diagnosed with epilepsy * Complaints of other sleep disorders * Current diagnosis of a psychiatric disorder requiring treatment * History of substance abuse or alcohol dependence * Pregnant or breastfeeding women * Women experiencing severe menopausal symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Insomnia Severity | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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. |
| Changes in Sleep Quality | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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. |
| Changes in Sleep parameters from sleep logs: sleep onset latency(SOL) | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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. |
| Changes in Sleep parameters from sleep logs: after sleep onset(WASO) | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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. |
| Changes in Sleep parameters from sleep logs: total sleep time(TST) | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE). |
| Changes in Sleep parameters from sleep logs: sleep efficiency(SE) | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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%. |
| Changes in Emotional State: BBTI App self-record | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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. |
| Changes in Emotional State: Profile of Mood States | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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. |
| Response Rate for Sleep-Related Lifestyle Self-Monitoring | From Day 1 to Day 28 of the intervention period | 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 | From Day 1 to Day 28 of the intervention period | 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 Assessed by the BBTI App | From Day 1 to Day 28 of the intervention period | 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 (%) |
| Difference in Overall Self-Monitoring Completion Rate Between Personalized and Non-Personalized ESM Reminder Groups | From Day 1 to Day 28 of the intervention period | 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 (%) |
| Changes in Sleep-Related Lifestyle Behaviors: BBTI App Self-Record | From Day 1 to Day 28 of the intervention period | 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. |
| Changes in Perceived Capability, Opportunity, and Motivation for Lifestyle Self-Monitoring | at baseline, Week 2, and Week 4, immediately after completion of 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 |
| Change in Insomnia-Related Lifestyle Knowledge, Attitudes, and Behaviors | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Symptom Rating Scale-5 (BSRS-5) | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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. |
| WHO-5 Well-Being Index | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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. |
| Rating Scale of Mental Effort in App Use Experience | at baseline, Week 2, and Week 4, participants completed the in-app assessment before the task and after completing the intervention. | 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 Collected by Smartwatch | From Day 1 to Day 28 of the intervention period | 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 Collected by Smartwatch | From Day 1 to Day 28 of the intervention period | 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 Collected by Smartwatch | From Day 1 to Day 28 of the intervention period | 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 Collected by Smartwatch | From Day 1 to Day 28 of the intervention period | 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 Collected by Smartwatch | From Day 1 to Day 28 of the intervention period | 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 Assessed by the System Usability Scale | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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 |
| User Experience of the BBTI App: User Experience Questionnaire | at baseline, Week 2, and Week 4, immediately after completion of the intervention. | 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 Assessed by NASA-TLX | During usability testing, Day 1 | 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 Assessed by EEG | During usability testing, Day 1 | 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 | During usability testing, Day 1 | 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 During Lifestyle Data Visualization Review | During usability testing, Day 1 | 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 |
Countries
Taiwan
Outcome results
None listed