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Not yet recruiting NCT07388849

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

— Observational Major Depressive Disorder (MDD) Sleep Disorders Circadian Rhythm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD), Sleep Disorders, Circadian Rhythm. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Can Rest-Activity Rhythm Profiles Predict Major Depressive Disorder? A Longitudinal Follow-up Study

Overview

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.

Primary outcome measures

  • Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) [Time frame: Baseline]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Hong Kong · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07388849 · PSY039

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗