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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
This intervention is a non-pharmacological approach that targets various factors contributing to sleep and circadian problems. It incorporates evidence-based elements such as CBT for insomnia, IPSRT, chronotherapy, and motivation enhancement. The treatment consists of 8 sessions with 4 cross-cutting modules: case formulation, sleep and circadian education, motivational interviewing, and goal setting. Participants also receive 4 core modules addressing sleep-wake regularity, daytime functioning, correcting beliefs, and maintaining behavioral change. Additionally, 6 optional modules cater to specific sleep-wake patterns, addressing sleep efficiency, excessive time in bed, delayed/advanced sleep phase, sleep-related worry, complex sleep environments, and nightmares. Modules are delivered based on individual needs. Sessions include agenda setting, homework review, treatment content delivery, goal assignment, and session summarization.
The Chinese University of Hong Kong
Shatin, Hong Kong
Change in Patient Health Questionnaire-9 (PHQ-9)
A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression.
Time frame: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
Change in Hospital Anxiety and Depression Scale (HADS)
A 14-item scale measuring anxiety and depression in both hospital and community settings.
Time frame: Baseline, and immediate post treatment assessment
Change in Insomnia Severity Index (ISI)
A 7-item scale used to assess the perceived severity of insomnia.
Time frame: Baseline, and immediate post treatment assessment
Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)
8-item scales to assess sleep and circadian functions.
Time frame: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
Change in Multidimensional Fatigue Inventory (MFI)
A 20-item scale used to assess five dimensions of fatigue.
Time frame: Baseline, and immediate post treatment assessment
Change in Short Form (6-Dimension) Health Survey (SF-6D)
A health survey used for measuring the quality of life on six dimensions.
Time frame: Baseline, and immediate post treatment assessment
Change in Sheehan Disability Scale (SDS)
A 5-item scale used to assess functional impairments in work/ school, social life, and family life.
Time frame: Baseline, and immediate post treatment assessment
Change in Core Consensus Standardized Sleep Diary
A 9-item scale used to record sleep time, wake time, perceived sleeping quality, and use of hypnotics.
Time frame: 10-week daily survey
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