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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TranS-C Group | Experimental | 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. |
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| Care-As-Usual Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian Dysfunction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) | A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression. | Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) | A 14-item scale measuring anxiety and depression in both hospital and community settings. | Baseline, and immediate post treatment assessment |
| Change in Insomnia Severity Index (ISI) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Treatment Acceptability/ Adherence Scale (TAAS) | A 10-item scale of the willingness to utilize or recommend the intervention. | Baseline, and immediate post treatment assessment |
| Change in Credibility-Expectancy Questionnaire (CEQ) |
Inclusion Criteria for the MDD group:
Exclusion Criteria for the MDD group:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012890 | Sleep |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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A 7-item scale used to assess the perceived severity of insomnia.
| 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. | 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. | 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. | 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. | 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. | 10-week daily survey |
A 6-item scale used to rate the treatment's credibility, satisfaction, and expectation for success.
| Baseline, and immediate post treatment assessment |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009784 | Occupational Diseases |
| D001523 | Mental Disorders |