Sleep and Circadian ProblemsNCT07277049
Optimisation and Evaluation of a Just-in-time Adaptive Intervention (JITAI) for Sleep and Circadian Problems (Phase III)
A study testing Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+) in people with Sleep and Circadian Problems, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep and Circadian Problems
- What is being tested?
- Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years living in Hong Kong
- Chinese language fluency and literacy
- Experiencing ≥1 sleep or circadian problems for 3 months based on the Sleep and Circadian Problems Interview, an adapted version of the Insomnia Interview Schedule (i.e., time needed to fall asleep ≥30 minutes for ≥3 nights per week, wake after sleep onset ≥30 minutes for ≥3 nights per week, <6-hour sleep per night or ≥9-hour sleep per night per 24-hour period for ≥3 nights per week, variability in the sleepweek schedule ≥2.78 hours within a week, and falling asleep after 2:00 AM on ≥3 nights per week)
- One or more PROMIS-Sleep Disturbance (PROMIS-SD) item scores ≥4 after reverse scoring
- Having adequate opportunity and circumstances for sleep to occur
- Installing the JITAI app in an Internet-enabled mobile device (iOS or Android operating system)
- Are willing to provide informed consent and comply with the trial protocol.
Who cannot join
- Involving in any psychological treatment for sleep disturbances in the past 6 months
- Self-report of a significant untreated severe mental illness (e.g., bipolar disorder, psychotic disorder)
- Presence of medical or cognitive disorder(s), or side effects of medication that contribute significantly to sleep or circadian problems or make participation challenging based on the team's clinical judgement
- Working night shift (>2 nights per week) in the past 3 weeks (i.e., regularly scheduled work from 12AM to 6AM)
- Pregnancy or breastfeeding
- Having a medical or psychiatric condition where sleep restriction is deemed unsuitable due to potential worsening of the condition
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- Other Criteria:
- Individuals who have sleep apnoea or periodic limb movement disorder commonly experience co-occurring insomnia will be included in the study due to the potential benefits they may derive from TranS-C
- To allow for greater generalisability, this study will not exclude those with mental disorders whose conditions are stable based on the research team's judgement
- If serious suicidal risk (i.e., Patient Health Questionnaire Item 9 score >2) is identified, the participant will be referred to the PA (a clinical psychologist) for further assessment and professional mental health services, if needed
- Medication use and changes will be recorded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimisation and Outcome Evaluation of a Just-in-time Adaptive Intervention (JITAI) for Sleep and Circadian Problems: A Micro-randomised Trial and a Randomised Controlled Trial
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.
Read more
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 III of the current research project.
- Conditions
- Sleep and Circadian Problems
- Being tested
- Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+)
- Keywords
- Just-in-time Adaptive Intervention (JITAI), sleep and circadian problems, sleep-wake patterns, insomnia, sleep, ecological momentary assessment, mHealth
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+)Behavioural
The JITAI (GoodShleep) will be adjusted and finalised based on the findings from Phase II (MRT) to transform into the optimised JITAI (GoodShleep+).
The optimized GoodShleep will be an 8-week, sleep- and circadian-targeted intervention programme. The intervention 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, five 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.
| Study group | Role | What they receive |
|---|---|---|
| Optimised just-in-time adaptive intervention (GoodShleep+) group | Experimental | Just-in-time adaptive interventions (JITAIs) are defined as interventions that combine two characteristics: just-in-time (intervening in exact moments of need to reduce fatigue and improve adherence) and adaptive (selecting and delivering tailored interventions with the right type and amount in an adaptive manner based on the user's dynamic internal state and environment, typically through ecological momentary assessment and wearables). A comprehensive framework for JITAI design encompasses six key elements, including (1) decision points, (2) tailoring variables, (3) intervention options, and (4) decision rules. These decisions are guided by (5) proximal outcomes and (6) distal outcomes.
The optimised Goodshleep+, which is based on and modified from the intervention protocol 'Transdiagnostic Intervention for Sleep and Circadian Dysfunction' (TranS-C) will be used. Context-based behavioural strategies will be suggested through push notifications based on specific decision rules. Receives: Behavioral: Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+) |
| Care-As-Usual Group | No intervention | The participants will not receive the Just-in-time Adaptive Intervention (GoodShleep+) but will have access to usual care based on their needs and preferences, including but not limited to pharmacological interventions, psychological interventions, and complementary and alternative medicine. An intervention tracking log will be used to monitor the care the participants receive during the study period. The CAU group will receive GoodShleep+ after completing all the assessments. The team will monitor the participants' weekly sleep and circadian functions using PROMIS- SD/SRI and refer those who have serious suicidal risk to the PA for further assessment and professional mental health services if deemed necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD)
8-item scales to assess sleep and circadian functions and impairments
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Patient-Reported Outcomes Measurement Information Sleep-Related Impairment (PROMIS-SRI)
8-item scales to assess sleep and circadian functions and impairments
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Secondary outcomes (12)
Change in Pittsburgh Sleep Quality Index (PSQI)
A 19-item scale assessing sleep quality over the past month
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in 7-day Consensus Sleep Diary
Records sleep time, wake time, perceived sleeping quality, and use of hypnotics on a daily basis
Measured: 20-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
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
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
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Epworth Sleepiness Scale (ESS)
An 8-item scale designed to evaluate overall daytime sleepiness
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Multidimensional Fatigue Inventory (MFI)
A 20-item instrument designed to measure fatigue symptoms
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Short Form (6-Dimension) Health Survey (SF-6D)
a preference-based single-index measure of the quality of life
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Sheehan Disability Scale (SDS)
A 5-item scale to assess functional impairment in work/school, social life and family life
Measured: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Treatment Acceptability/Adherence Scale (TAAS)
a 10-item scale of the willingness to utilise or recommend the intervention
Measured: 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
Measured: Baseline, immediate post-intervention assessment (Week 9)
Change in System Usability Scale (SUS)
A 10-item scale evaluating the usability perception of an app
Measured: 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 expections during water sports activities.
Measured: 8-week on a daily basis, 24 hours a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep and Circadian ProblemsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277049
- Sponsor's protocol ID
- PSY037
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation and Outcome Evaluation of a Just-in-time Adaptive Intervention (JITAI) for Sleep and Circadian Problems: A Micro-randomised Trial and a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07277049
- Acronym / sponsor ID
- PSY037
- Conditions
- Sleep and Circadian Problems
- Keywords
- Just-in-time Adaptive Intervention (JITAI), sleep and circadian problems, sleep-wake patterns, insomnia, sleep, ecological momentary assessment, mHealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 III of the current research project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimised just-in-time adaptive intervention (GoodShleep+) group | Experimental | Behavioral: Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+)Just-in-time adaptive interventions (JITAIs) are defined as interventions that combine two characteristics: just-in-time (intervening in exact moments of need to reduce fatigue and improve adherence) and adaptive (selecting and delivering tailored interventions with the right type and amount in an adaptive manner based on the user's dynamic internal state and environment, typically through ecological momentary assessment and wearables). A comprehensive framework for JITAI design encompasses six key elements, including (1) decision points, (2) tailoring variables, (3) intervention options, and (4) decision rules. These decisions are guided by (5) proximal outcomes and (6) distal outcomes. The optimised Goodshleep+, which is based on and modified from the intervention protocol 'Transdiagnostic Intervention for Sleep and Circadian Dysfunction' (TranS-C) will be used. Context-based behavioural strategies will be suggested through push notifications based on specific decision rules. |
| Care-As-Usual Group | No intervention | –The participants will not receive the Just-in-time Adaptive Intervention (GoodShleep+) but will have access to usual care based on their needs and preferences, including but not limited to pharmacological interventions, psychological interventions, and complementary and alternative medicine. An intervention tracking log will be used to monitor the care the participants receive during the study period. The CAU group will receive GoodShleep+ after completing all the assessments. The team will monitor the participants' weekly sleep and circadian functions using PROMIS- SD/SRI and refer those who have serious suicidal risk to the PA for further assessment and professional mental health services if deemed necessary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 65 years living in Hong Kong
- Chinese language fluency and literacy
- Experiencing ≥1 sleep or circadian problems for 3 months based on the Sleep and Circadian Problems Interview, an adapted version of the Insomnia Interview Schedule (i.e., time needed to fall asleep ≥30 minutes for ≥3 nights per week, wake after sleep onset ≥30 minutes for ≥3 nights per week, <6-hour sleep per night or ≥9-hour sleep per night per 24-hour period for ≥3 nights per week, variability in the sleepweek schedule ≥2.78 hours within a week, and falling asleep after 2:00 AM on ≥3 nights per week)
- One or more PROMIS-Sleep Disturbance (PROMIS-SD) item scores ≥4 after reverse scoring
- Having adequate opportunity and circumstances for sleep to occur
Key exclusion criteria (11 listed)
- Involving in any psychological treatment for sleep disturbances in the past 6 months
- Self-report of a significant untreated severe mental illness (e.g., bipolar disorder, psychotic disorder)
- Presence of medical or cognitive disorder(s), or side effects of medication that contribute significantly to sleep or circadian problems or make participation challenging based on the team's clinical judgement
- Working night shift (>2 nights per week) in the past 3 weeks (i.e., regularly scheduled work from 12AM to 6AM)
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+)The JITAI (GoodShleep) will be adjusted and finalised based on the findings from Phase II (MRT) to transform into the optimised JITAI (GoodShleep+). The optimized GoodShleep will be an 8-week, sleep- and circadian-targeted intervention programme. The intervention 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, five 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. | Behavioural | Optimised just-in-time adaptive intervention (GoodShleep+) group |
Primary outcome
Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
8-item scales to assess sleep and circadian functions and impairments
Change in Patient-Reported Outcomes Measurement Information Sleep-Related Impairment (PROMIS-SRI)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
8-item scales to assess sleep and circadian functions and impairments
12 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in 7-day Consensus Sleep Diary
Time frame: 20-week daily survey
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in 16-item version of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Epworth Sleepiness Scale (ESS)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Short Form (6-Dimension) Health Survey (SF-6D)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Sheehan Disability Scale (SDS)
Time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)
Change in Treatment Acceptability/Adherence Scale (TAAS)
Time frame: Baseline, immediate post-intervention assessment (Week 9)
Change in Credibility-Expectancy Questionnaire (CEQ)
Time frame: Baseline, immediate post-intervention assessment (Week 9)
Change in System Usability Scale (SUS)
Time frame: Immediate post-intervention assessment (Week 9)
Change in wearable-derived rest-activity data
Time frame: 8-week on a daily basis, 24 hours a day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+) in people with Sleep and Circadian Problems, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) (time frame: Baseline, immediate post-intervention assessment (Week 9), 12-week post-intervention assessment (Week 20)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.