Can Rest-Activity Rhythm Profiles Predict Major Depressive Disorder? A Longitudinal Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
结局指标
主要结局
Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV)
时间窗: 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.
次要结局
- 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)
- Change in the Multidimensional Fatigue Inventory (MFI-20)(Baseline, Day 7, Day 14)
- Change in the Short Form (6-Dimension) Health Survey (SF-6D)(Baseline, Day 7, Day 14)
- Change in sleep time(14-day daily survey)
- Change in wake time(14-day daily survey)
- Change in perceived sleeping quality(14-day daily survey)
- Change in use of hypnotics(14-day daily survey)
- Change in actigraphy-derived rest-activity pattern(14-day on a daily basis, 24 hours a day)
研究者
Fiona YY Ho
Associate Professor
Chinese University of Hong Kong