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The JITAI approach holds considerable promise for addressing current challenges in mHealth, including the limitations in supporting real-time monitoring, timely intervention, and poor adherence. However, research on JITAIs in the field of behavioural sleep medicine is still in its infancy. Leveraging existing pilot data, this project will entail a micro-randomised trial (MRT) designed to optimise the JITAI components and a randomised controlled trial (RCT) to examine the efficacy of the optimised JITAI on sleep and circadian functions. Specifically, research has indicated that contextually tailored suggestions are more effective in promoting health behaviors compared to generic messages. This study will include personalised, in-the-moment actionable suggestions based on the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to evaluate their efficacy in contrast to generic messages and no notifications.
The proposed project will have three phases. Phase I will be the technological advancement of the JITAI app, GoodShleep. Based on research findings, additional intervention engagement strategies will be added to improve adherence, including personalisation (i.e., personalised feedback and intervention content), gamification (i.e., goal setting and rewards for a completed mission), and reminders (i.e., push notifications). The refined app will be beta-tested by the research team and five individuals experiencing sleep or circadian problems to ensure the app's functionality and usability. Issues that may arise during Phase I will be resolved prior to commencing Phase II.
Phase II will be an MRT aiming to optimise the advanced GoodShleep alongside wearable devices and ecological momentary assessment (EMA). A total of 77 participants with sleep or circadian problems will participate in the JITAI through the advanced GoodShleep, which will comprise (1) an 8-week, smartphone-based JITAI on TranS-C; (2) EMA prompted by push notifications to detect sleep-wake regularity and mood status; and (3) 24-hour real-time wearables assessing sleep and activity. Participants will be randomly assigned to receive contextually personalised suggestions, generic messages, and no notifications based on our micro-randomised algorithm.
Phase III will involve an RCT to evaluate the optimised JITAI app, GoodShleep + in both short- (immediately after intervention) and medium-term (12 weeks after intervention). Eighty participants with sleep and circadian problems will be randomised into the optimised JITAI (GoodShleep+) and the care-as-usual (CAU) group in a 1:1 allocation ratio. The JITAI (GoodShleep) will be adjusted and finalised based on the findings from Phase II to transform into the optimised JITAI (GoodShleep+). The GoodShleep+ group will receive an 8-week, smartphone-based GoodShleep+ based on TranS-C. The CAU group will not receive the GoodShleep+ but will have access to usual care based on their needs and preferences. The CAU group will receive GoodShleep+ after completing all the assessments. Major assessments will be conducted at baseline, immediate post-intervention and 12-week follow-up. Participants' sleep conditions will be evaluated using the brief consensus sleep diary and wearables. Activity levels will be measured using wearables at multiple time points. Mood status will be assessed using selected items from PANAS-SF. Participants' weekly sleep and circadian functions will be monitored using Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI). Other outcomes will include sleep quality, anxiety and depression symptoms, sleep-related cognitions, overall daytime sleepiness, fatigue, quality of life and functional impairment. Intervention acceptability and intervention adherence will also be assessed.
The current registration is only for Phase I and II of the current research project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Just-in-time adaptive intervention (GoodShleep) group | Experimental | Participants will be micro-randomised to the delivery of the behavioural components at each of the 4 decision points daily, with a 37.5% chance of being micro-randomised to contextually personalised suggestions, 37.5% to generic messages, and 25% to no notifications. The randomisation process will be independent to prior randomisations and the participants' responses to previously delivered intervention suggestions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep) | Behavioral | GoodShleep will comprise (1) an 8-week, smartphone-based JITAI on TranS-C; (2) EMA prompted by push notifications to detect sleep-wake regularity and mood status; and (3) 24-hour real-time wearables assessing sleep and activity. The TranS-C materials will be presented in text format supplemented with diagrams, video/audio clips, quizzes, and culturally relevant examples. Across the 8 sessions, 4 cross-cutting modules will be introduced, including case formulation, sleep and circadian education, motivational interviewing, and goal setting. In addition, the participants will receive 4 core modules addressing sleep-wake regularity, daytime functioning, correcting beliefs, and maintaining behavioral change. Additionally, 5 selected optional modules will be delivered based on the participant's sleep-wake features and presentations addressing sleep efficiency, excessive time in bed, delayed/advanced sleep phase, sleep-related worry, and nightmares. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) | 8-item scales to assess sleep and circadian functions and impairments | Baseline, immediate post-intervention assessment (Week 9) |
| Change in Patient-Reported Outcomes Measurement Information Sleep-Related Impairment (PROMIS-SRI) | 8-item scales to assess sleep and circadian functions and impairments | Baseline, immediate post-intervention assessment (Week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) | A 19-item scale assessing sleep quality over the past month | Baseline, immediate post-intervention assessment (Week 9) |
| Change in 7-day Consensus Sleep Diary |
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Inclusion Criteria:
Exclusion Criteria:
Other Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong |
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The Phase II of this study uses a micro-randomized trial (MRT) design to optimise the advanced GoodShleep alongside wearable devices and EMA. Participants will participate in the JITAI through the advanced GoodShleep and will be randomly assigned to receive contextually personalised suggestions (probability 0.375), generic messages (probability 0.375), and no notifications (probability 0.3) based on our micro-randomised algorithm at a decision point.
These notifications are intended to serve as cues to action, enhancing the participants' readiness to engage in sleep-promoting behaviours in accordance with the health belief models. The notifications will complement the 8-week, modular TranS-C intervention, which is thoroughly described in the Intervention Protocol section. All participants will receive the cross-cutting modules and core modules of TranS-C, along with selected optional modules based on the specific needs of each participant.
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The participants and outcomes assessor will also be blinded during the micro-randomization.
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Records sleep time, wake time, perceived sleeping quality, and use of hypnotics on a daily basis
| 8-week daily survey |
| Change in Hospital Anxiety and Depression Scale (HADS) | A 14-item scale measuring anxiety and depression in both hospital and community settings | Baseline, immediate post-intervention assessment (Week 9) |
| Change in 16-item version of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) | A 16-item scale to assess sleep-related cognitions | Baseline, immediate post-intervention assessment (Week 9) |
| Change in Epworth Sleepiness Scale (ESS) | An 8-item scale designed to evaluate overall daytime sleepiness | Baseline, immediate post-intervention assessment (Week 9) |
| Change in Multidimensional Fatigue Inventory (MFI) | A 20-item instrument designed to measure fatigue symptoms | Baseline, immediate post-intervention assessment (Week 9) |
| Change in Short Form (6-Dimension) Health Survey (SF-6D) | A preference-based single-index measure of the quality of life | Baseline, immediate post-intervention assessment (Week 9) |
| Change in Sheehan Disability Scale (SDS) | A 5-item scale to assess functional impairment in work/school, social life and family life | Baseline, immediate post-intervention assessment (Week 9) |
| Change in Treatment Acceptability/Adherence Scale (TAAS) | A 10-item scale of the willingness to utilise or recommend the intervention | Baseline, immediate post-intervention assessment (Week 9) |
| Change in Credibility-Expectancy Questionnaire (CEQ) | A 6-item scale used to yield ratings of intervention credibility and the expectation of success | Baseline, immediate post-intervention assessment (Week 9) |
| Change in System Usability Scale (SUS) | A 10-item scale evaluating the usability perception of an app | Immediate post-intervention assessment (Week 9) |
| Change in wearable-derived rest-activity data | 24-hour rest-activity data will be collected using research-grade wearables (actigraphy). Participants will be instructed to wear the device on their non- dominant wrist, 24 hours a day, for 8 consecutive weeks, with exceptions during water sports activities. | 8-week on a daily basis, 24 hours a day |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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