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

The Chinese University of Hong Kong

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07388849

PSY039

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

160 participants in 2 patient groups

Major Depressive Disorder Group

Description:

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

Description:

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.