Depression, Sleep Disorders, Circadian Rhythm
Conditions
Keywords
Actigraphy, Transdiagnostic Intervention, Depression, Rest-Activity Rhythm
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.
Interventions
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
for the MDD group: 1. Adults aged 18-65 years living in Hong Kong 2. Being fluent and literate in Cantonese 3. A Patient Health Questionnaire-9 (PHQ-9) score of at least 10, indicating a moderate level of depression. 4. Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI) 5. 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) 6. Access to an Internet-enabled mobile device (iOS or Android operating system) 7. Willingness to provide informed consent and comply with the trial protocol.
Exclusion criteria
for the MDD group: 1. Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience 2. Presence of other psychiatric disorders as assessed by MINI 3. A history of electroconvulsive therapy (ECT) 4. Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems 5. A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment 6. Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns 7. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Treatment Acceptability/ Adherence Scale (TAAS) | Baseline, and immediate post treatment assessment | A 10-item scale of the willingness to utilize or recommend the intervention. |
| Change in Credibility-Expectancy Questionnaire (CEQ) | Baseline, and immediate post treatment assessment | A 6-item scale used to rate the treatment's credibility, satisfaction, and expectation for success. |
Countries
Hong Kong
Outcome results
None listed