A Longitudinal Follow-Up Study on Predicting Major Depressive Disorder From Rest-Activity Rhythm Profiles
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 2 trial groupsGroup A: Major Depressive Disorder Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
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.
Time frame
BaselineSecondary outcomes
1
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.
Time frame
Baseline, Day 7, Day 142
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.
Time frame
Baseline, Day 7, Day 143
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.
Time frame
Baseline, Day 7, Day 144
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.
Time frame
Baseline, Day 7, Day 14Sponsors and contacts
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Source ClinicalTrials.gov
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