Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
The proposed study will include a longitudinal ecological study (Study 1) and a randomised controlled trial (Study 2). The aims will be to (1) identify the sleep-wake profiles in individuals with MDD through clustering; (2) examine the associations between sleep-wake features/profiles and the prognosis of MDD; and (3) investigate the anti-depressant effects of sleep- and circadian-targeted intervention in those with MDD and whether sleep-wake features/profiles may moderate the treatment outcomes. 70 depressed participants from Study 1 will be randomized to Study 2 for the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) group and the care-as-usual (CAU) group in a 1:1 allocation ratio. The study period will be 8 weeks. Major assessments at baseline and immediate post-treatment will be managed by an independent assessor (a research assistant, RA) who is blind to the group allocation. The proposed trial and the nested pilot study will follow the CONSORT and STROBE guidelines, respectively. The intervention will be provided free of charge.The current registration is only for Study 2 of the current research project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for the MDD group:
- •Adults aged 18-65 years living in Hong Kong
- •Being fluent and literate in Cantonese
- •A Patient Health Questionnaire-9 (PHQ-9) score of at least 10, indicating a moderate level of depression.
- •Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
- •Experiencing ≥ 1 sleep or circadian problem in the past 3 months according to the sleep and circadian problems checklist (i.e., time needed to fall asleep ≥ 30 minutes, wake after sleep onset ≥ 30 minutes, < 6-hour sleep per night or ≥ 9-hour sleep per night per 24-hour period, and falling asleep after 2:00 AM ≥ 3 nights per week; and variability in the sleep-wake schedule ≥ 2.78 hours within a week)
- •Access to an Internet-enabled mobile device (iOS or Android operating system)
- •Willingness to provide informed consent and comply with the trial protocol.
排除标准
- •for the MDD group:
- •Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
- •Presence of other psychiatric disorders as assessed by MINI
- •A history of electroconvulsive therapy (ECT)
- •Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems
- •A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment
- •Shift work, pregnancy, or 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 SLEEP-50 (narcolepsy ≥ 7; OSA ≥ 15; RLS/PLMD ≥ 7)
研究组 & 干预措施
TranS-C Group
TranS-C is a personalized, non-pharmacological transdiagnostic intervention that addresses psychosocial, behavioural, and cognitive contributors to sleep and circadian dysfunction. It references the sleep health framework and integrates evidence-based elements, including CBT for insomnia, interpersonal and social rhythm therapy (IPSRT), chronotherapy, and motivation enhancement.
干预措施: Transdiagnostic Intervention for Sleep and Circadian Dysfunction (Behavioral)
Care-As-Usual Group
The participants in this group will not receive the TranS-C treatment but will have access to usual care based on their needs and preferences, including but not limited to pharmacological interventions, psychological interventions, and complementary and alternative medicine. A treatment tracking log will be used to monitor the care the participants receive during the study period. The CAU group will receive self-help TranS-C materials after completing all of the assessments. We will monitor the participants' weekly depression severity using PHQ-9 and refer those who have serious suicidal risk to the PI for further assessment and professional mental health services if deemed necessary.
结局指标
主要结局
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression.
次要结局
- Change in Sheehan Disability Scale (SDS)(Baseline, and immediate post treatment assessment)
- Change in Hospital Anxiety and Depression Scale (HADS)(Baseline, and immediate post treatment assessment)
- Change in Insomnia Severity Index (ISI)(Baseline, and immediate post treatment assessment)
- Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)(Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments)
- Change in Multidimensional Fatigue Inventory (MFI)(Baseline, and immediate post treatment assessment)
- Change in Short Form (6-Dimension) Health Survey (SF-6D)(Baseline, and immediate post treatment assessment)
- Change in Core Consensus Standardized Sleep Diary(10-week daily survey)
研究者
Fiona YY Ho
Associate Professor
Chinese University of Hong Kong