Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD

Not Applicable

Not yet recruiting

Interventions: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
TranS-C Group	Transdiagnostic Intervention for Sleep and Circadian Dysfunction	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.

Primary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire-9 (PHQ-9)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Sheehan Disability Scale (SDS)	Baseline, and immediate post treatment assessment	A 5-item scale used to assess functional impairments in work/ school, social life, and family life.
Change in Hospital Anxiety and Depression Scale (HADS)	Baseline, and immediate post treatment assessment	A 14-item scale measuring anxiety and depression in both hospital and community settings.
Change in Insomnia Severity Index (ISI)	Baseline, and immediate post treatment assessment	A 7-item scale used to assess the perceived severity of insomnia.
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	8-item scales to assess sleep and circadian functions.
Change in Multidimensional Fatigue Inventory (MFI)	Baseline, and immediate post treatment assessment	A 20-item scale used to assess five dimensions of fatigue.
Change in Short Form (6-Dimension) Health Survey (SF-6D)	Baseline, and immediate post treatment assessment	A health survey used for measuring the quality of life on six dimensions.
Change in Core Consensus Standardized Sleep Diary	10-week daily survey	A 9-item scale used to record sleep time, wake time, perceived sleeping quality, and use of hypnotics.