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

NCT07388849 | Not Yet Recruiting

• 1 other identifier: PSY039
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Major Depressive Disorder (MDD); Sleep Disorders; Circadian Rhythm

Keywords

Actigraphy; Major Depressive Disorder; Rest-activity Rhythm; Longitudinal Study

Outcome Measures

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.

  Baseline

Secondary Outcomes (12)

• Change in Hospital Anxiety and Depression Scale (HADS)

  Baseline, Day 7, Day 14

• Change in Insomnia Severity Index (ISI)

  Baseline, Day 7, Day 14

• Change in the Young Mania Rating Scale (YMRS)

  Baseline, Day 7, Day 14

• Change in the Morningness-Eveningness Questionnaire (MEQ)

  Baseline, Day 7, Day 14

• Change in the Positive and Negative Affect Schedule (PANAS)

  14-day daily survey

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

HK (1)