Clinical trial NCT06181110: Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD
Official title: Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Sleep Disorders, Circadian Rhythm
Keywords: Actigraphy
Transdiagnostic Intervention
Depression
Rest-Activity Rhythm
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, and immediate post treatment assessment
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline, and immediate post treatment assessment
measure: Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)
timeFrame: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
measure: Change in Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, and immediate post treatment assessment
measure: Change in Short Form (6-Dimension) Health Survey (SF-6D)
timeFrame: Baseline, and immediate post treatment assessment
measure: Change in Sheehan Disability Scale (SDS)
timeFrame: Baseline, and immediate post treatment assessment
measure: Change in Core Consensus Standardized Sleep Diary
timeFrame: 10-week daily survey
Other outcomes:
measure: Change in Treatment Acceptability/ Adherence Scale (TAAS)
timeFrame: Baseline, and immediate post treatment assessment
measure: Change in Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline, and immediate post treatment assessment
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: