A Longitudinal Follow-Up Study on Predicting Major Depressive Disorder From Rest-Activity Rhythm Profiles

January 28, 2026 updated by: Fiona YY Ho, Chinese University of Hong Kong

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Exclusion criteria for actigraphy assessment:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, Day 7, Day 14
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.
Baseline, Day 7, Day 14
Change in Insomnia Severity Index (ISI)
Time Frame: Baseline, Day 7, Day 14
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.
Baseline, Day 7, Day 14
Change in the Young Mania Rating Scale (YMRS)
Time Frame: Baseline, Day 7, Day 14
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.
Baseline, Day 7, Day 14
Change in the Morningness-Eveningness Questionnaire (MEQ)
Time Frame: Baseline, Day 7, Day 14
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.
Baseline, Day 7, Day 14
Change in the Positive and Negative Affect Schedule (PANAS)
Time Frame: 14-day daily survey
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.
14-day daily survey
Change in the Multidimensional Fatigue Inventory (MFI-20)
Time Frame: Baseline, Day 7, Day 14
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.
Baseline, Day 7, Day 14
Change in the Short Form (6-Dimension) Health Survey (SF-6D)
Time Frame: Baseline, Day 7, Day 14
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.
Baseline, Day 7, Day 14
Change in sleep time
Time Frame: 14-day daily survey
Recorded daily using the Consensus Sleep Diary.
14-day daily survey
Change in wake time
Time Frame: 14-day daily survey
Recorded daily using the Consensus Sleep Diary.
14-day daily survey
Change in perceived sleeping quality
Time Frame: 14-day daily survey
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.
14-day daily survey
Change in use of hypnotics
Time Frame: 14-day daily survey
Recorded daily using the Consensus Sleep Diary.
14-day daily survey
Change in actigraphy-derived rest-activity pattern
Time Frame: 14-day on a daily basis, 24 hours a day
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.
14-day on a daily basis, 24 hours a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSY039

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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