Major Depressive Disorder (MDD)NCT07388849
A Longitudinal Follow-Up Study on Predicting Major Depressive Disorder From Rest-Activity Rhythm Profiles
An observational study of Major Depressive Disorder (MDD) and Sleep Disorders, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This proposed study will be a longitudinal follow-up study of a case-control study of 160 participants (CREC Ref: 2023.234). This study aims to follow up on the trajectory of depression and rest-activity rhythm (RAR) disruptions, as well as examine their association over time. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD), Sleep Disorders, Circadian Rhythm
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2026to 28 Feb 2029
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be 160 participants (80 participants with Major Depressive Disorder and 80 age- and gender-matched healthy controls) who participated in a case-control study carried out from 2023 Aug to 2025 Feb in Hong Kong. Those participants will be invited to participate in this study via message, phone call, or email.
Who may be able to join
- Hong Kong residents aged 18 to 70 years
- Chinese language fluency
- Accessibility to an Internet-enabled mobile device
- A willingness to provide informed consent and comply with the study protocol
Who cannot join
- Severe medical or neurocognitive disorders that make participation unsuitable
- History of electroconvulsive therapy (ECT)
- An unstable use of psychotropic drugs (medication use has to remain stable for at least 6 weeks before baseline assessment)
- Current involvement in any psychological treatment program that targets depression and/or sleep problems
- The investigators will not exclude those with current suicidal risks (i.e., non-fleeting intent or plan), which is a common symptom of MDD. However, if serious suicidal risk (i.e., PHQ-9 Item 9 score > 2) is identified, the participant will be referred to the PI (a clinical psychologist) for further assessment and professional mental health services if deemed necessary.
- Shift work, pregnancy, work, family, or other commitments that interfere with regular sleep-wake patterns
- Presence of other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores of individual sections in SLEEP-50 (narcolepsy ≥ 7; OSA ≥ 15; RLS/PLMD ≥ 7)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Chun-Yin Poon, +852 39436575, evanpcy99@link.cuhk.edu.hk
About this study
Official title: Can Rest-Activity Rhythm Profiles Predict Major Depressive Disorder? A Longitudinal Follow-up Study
This proposed study will be a longitudinal follow-up study of a case-control study of 160 participants (CREC Ref: 2023.234). This study aims to follow up on the trajectory of depression and rest-activity rhythm (RAR) disruptions, as well as examine their association over time. The investigators aim to identify distinctive RAR profiles of MDD using the data from the original project and hypothesize that two or more groups will be identified based on individual RAR variables using cluster analysis. The investigators hypothesize that significant differences in depressive symptom severity, sleep quality, and other outcome measures collected in this follow-up will be found between the clustered groups. Individuals exhibiting the most disrupted RAR profiles are hypothesized to have the greatest deterioration in depression symptom severity and other outcome measures. The investigators also hypothesize that people persisting with MDD will exhibit greater disruptions in RAR compared to those without MDD at the follow-up. Furthermore, the investigators will examine whether individual RAR parameters are longitudinally associated with changes in depression symptom severity and other outcome measures.
- Keywords
- Actigraphy, Major Depressive Disorder, Rest-activity Rhythm, Longitudinal Study
- Medical subject headings
- Depressive Disorder, Major, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder Group | This group includes participants who meet the DSM-5 diagnostic criteria for current Major Depressive Disorder based the structured clinical interview SCID-5-RV. In this study, all participants will be given a structured clinical interview SCID-5-RV, complete the baseline assessment and then proceed to 14 days of monitoring of sleep, mood, and activity levels. Objective sleep measurements will be collected through actigraphy (e.g., ActiGraph accelerometer), while subjective sleep measurements will be collected using a 14-day sleep diary and self-report measures. The participants who are eligible for actigraphy assessment will also be instructed to wear the device on their non-dominant wrist 24 hours a day for 14 consecutive days. | |
| Control Group | This group includes participants who do not meet the DSM-5 diagnostic criteria for current Major Depressive Disorder based the structured clinical interview SCID-5-RV. In this study, all participants will be given a structured clinical interview SCID-5-RV, complete the baseline assessment and then proceed to 14 days of monitoring of sleep, mood, and activity levels. Objective sleep measurements will be collected through actigraphy (e.g., ActiGraph accelerometer), while subjective sleep measurements will be collected using a 14-day sleep diary and self-report measures. The participants who are eligible for actigraphy assessment will also be instructed to wear the device on their non-dominant wrist 24 hours a day for 14 consecutive days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV)
A structured clinical interview for making the major DSM-5 diagnoses. This measure will be used to evaluate the presence of major depressive disorder and other psychiatric conditions, including subtypes of depression.
Measured: Baseline
Secondary outcomes (12)
Change in Hospital Anxiety and Depression Scale (HADS)
A 14-item self-report scale used to measure the symptom severity of anxiety (7-item subscale) and depression (7-item subscale). The minimum score is 0 while maximum socre is 42. Higher scores indicate greater distress.
Measured: Baseline, Day 7, Day 14
Change in Insomnia Severity Index (ISI)
A 7-item self-report scale commonly used to assess the perceived severity of insomnia. The minimum score is 0 while maximum socre is 28. Higher scores indicate greater distress.
Measured: Baseline, Day 7, Day 14
Change in the Young Mania Rating Scale (YMRS)
An 11-item scale used to assess subjective manic symptoms. The minimum score is 0 while maximum socre is 60. Higher scores indicate greater distress.
Measured: Baseline, Day 7, Day 14
Change in the Morningness-Eveningness Questionnaire (MEQ)
A 19-item self-report questionnaire used to measure the chronotype of human circadian rhythms. The minimum score is 16 while maximum socre is 86. Lower scores indicate eveningness, while higher scores indicate morningness.
Measured: Baseline, Day 7, Day 14
Change in the Positive and Negative Affect Schedule (PANAS)
A 20-item scale commonly used to measure positive (10-item subscale) and negative affect (10-item subscale). Each item is rated on a 5-point Likert scale ranging from 1 to 5. Total scores on the scale range from 20 to 100, with higher scores on each subscale indicating greater levels of the respective affect. Specifically, a higher score on the positive affect subscale reflects higher levels of positive emotions, while a higher score on the negative affect subscale reflects higher levels of negative emotions.
Measured: 14-day daily survey
Change in the Multidimensional Fatigue Inventory (MFI-20)
A 20-item scale used to assess five dimensions of fatigue, with each subscale score ranging from 4 to 20. The total score ranges from 20 to 100. Higher scores indicate more severe fatigue.
Measured: Baseline, Day 7, Day 14
Change in the Short Form (6-Dimension) Health Survey (SF-6D)
A health survey used for measuring the quality of life on six dimensions. The scale is scored by converting participants' responses across six health dimensions into predefined utility weights and combining them using a standard multi-attribute algorithm to produce a single health-related quality-of-life score ranging from approximately 0.29 (worst) to 1.00 (full health). Higher scores indicate better health.
Measured: Baseline, Day 7, Day 14
Change in sleep time
Recorded daily using the Consensus Sleep Diary.
Measured: 14-day daily survey
Change in wake time
Recorded daily using the Consensus Sleep Diary.
Measured: 14-day daily survey
Change in perceived sleeping quality
Recorded daily using the Consensus Sleep Diary. The minimum score is 1 while the maximum score is 4. Higher scores indicate better perceived sleeping quality.
Measured: 14-day daily survey
Change in use of hypnotics
Recorded daily using the Consensus Sleep Diary.
Measured: 14-day daily survey
Change in actigraphy-derived rest-activity pattern
24-hour rest-activity pattern will be collected using research-grade wearables (actigraphy), a validated physiological measurement tool that continuously records movement to estimate sleep-wake cycles. Participants will be instructed to wear the actigraphy on their non- dominant wrist, 24 hours a day, for 14 consecutive days, with exceptions during water sports activities.
Measured: 14-day 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 posted5 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 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 Major Depressive Disorder (MDD)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 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
- NCT07388849
- Sponsor's protocol ID
- PSY039
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 5 Feb 2026
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Rest-Activity Rhythm Profiles Predict Major Depressive Disorder? A Longitudinal Follow-up Study
- ClinicalTrials.gov ID
- NCT07388849
- Acronym / sponsor ID
- PSY039
- Keywords
- Actigraphy, Major Depressive Disorder, Rest-activity Rhythm, Longitudinal Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 5 Feb 2026 (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.
This proposed study will be a longitudinal follow-up study of a case-control study of 160 participants (CREC Ref: 2023.234). This study aims to follow up on the trajectory of depression and rest-activity rhythm (RAR) disruptions, as well as examine their association over time. The investigators aim to identify distinctive RAR profiles of MDD using the data from the original project and hypothesize that two or more groups will be identified based on individual RAR variables using cluster analysis. The investigators hypothesize that significant differences in depressive symptom severity, sleep quality, and other outcome measures collected in this follow-up will be found between the clustered groups. Individuals exhibiting the most disrupted RAR profiles are hypothesized to have the greatest deterioration in depression symptom severity and other outcome measures. The investigators also hypothesize that people persisting with MDD will exhibit greater disruptions in RAR compared to those without MDD at the follow-up. Furthermore, the investigators will examine whether individual RAR parameters are longitudinally associated with changes in depression symptom severity and other outcome measures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder Group | – | –This group includes participants who meet the DSM-5 diagnostic criteria for current Major Depressive Disorder based the structured clinical interview SCID-5-RV. In this study, all participants will be given a structured clinical interview SCID-5-RV, complete the baseline assessment and then proceed to 14 days of monitoring of sleep, mood, and activity levels. Objective sleep measurements will be collected through actigraphy (e.g., ActiGraph accelerometer), while subjective sleep measurements will be collected using a 14-day sleep diary and self-report measures. The participants who are eligible for actigraphy assessment will also be instructed to wear the device on their non-dominant wrist 24 hours a day for 14 consecutive days. |
| Control Group | – | –This group includes participants who do not meet the DSM-5 diagnostic criteria for current Major Depressive Disorder based the structured clinical interview SCID-5-RV. In this study, all participants will be given a structured clinical interview SCID-5-RV, complete the baseline assessment and then proceed to 14 days of monitoring of sleep, mood, and activity levels. Objective sleep measurements will be collected through actigraphy (e.g., ActiGraph accelerometer), while subjective sleep measurements will be collected using a 14-day sleep diary and self-report measures. The participants who are eligible for actigraphy assessment will also be instructed to wear the device on their non-dominant wrist 24 hours a day for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be 160 participants (80 participants with Major Depressive Disorder and 80 age- and gender-matched healthy controls) who participated in a case-control study carried out from 2023 Aug to 2025 Feb in Hong Kong. Those participants will be invited to participate in this study via message, phone call, or email.
Key inclusion criteria (4 listed)
- Hong Kong residents aged 18 to 70 years
- Chinese language fluency
- Accessibility to an Internet-enabled mobile device
- A willingness to provide informed consent and comply with the study protocol
Key exclusion criteria (7 listed)
- Severe medical or neurocognitive disorders that make participation unsuitable
- History of electroconvulsive therapy (ECT)
- An unstable use of psychotropic drugs (medication use has to remain stable for at least 6 weeks before baseline assessment)
- Current involvement in any psychological treatment program that targets depression and/or sleep problems
- The investigators will not exclude those with current suicidal risks (i.e., non-fleeting intent or plan), which is a common symptom of MDD. However, if serious suicidal risk (i.e., PHQ-9 Item 9 score > 2) is identified, the participant will be referred to the PI (a clinical psychologist) for further assessment and professional mental health services if deemed necessary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV)
Time frame: Baseline
A structured clinical interview for making the major DSM-5 diagnoses. This measure will be used to evaluate the presence of major depressive disorder and other psychiatric conditions, including subtypes of depression.
12 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Day 7, Day 14
Change in Insomnia Severity Index (ISI)
Time frame: Baseline, Day 7, Day 14
Change in the Young Mania Rating Scale (YMRS)
Time frame: Baseline, Day 7, Day 14
Change in the Morningness-Eveningness Questionnaire (MEQ)
Time frame: Baseline, Day 7, Day 14
Change in the Positive and Negative Affect Schedule (PANAS)
Time frame: 14-day daily survey
Change in the Multidimensional Fatigue Inventory (MFI-20)
Time frame: Baseline, Day 7, Day 14
Change in the Short Form (6-Dimension) Health Survey (SF-6D)
Time frame: Baseline, Day 7, Day 14
Change in sleep time
Time frame: 14-day daily survey
Change in wake time
Time frame: 14-day daily survey
Change in perceived sleeping quality
Time frame: 14-day daily survey
Change in use of hypnotics
Time frame: 14-day daily survey
Change in actigraphy-derived rest-activity pattern
Time frame: 14-day 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 5 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD) and Sleep Disorders, 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 4 inclusion and 7 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 5 Feb 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) (time frame: Baseline). 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 5 Feb 2026.