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Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy | Clinical Trials | Clareo Health

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Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy

Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder

NCT06233422•Chinese University of Hong Kong

View on ClinicalTrials.gov

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 Major Depressive Disorder (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. In Study 1, a total of 140 participants comprising 70 participants with MDD and 70 age- and gender-matched healthy controls will be recruited. Sleep-wake patterns will be collected for 4 consecutive weeks using actigraphy devices and one-off self-report measures will be collected via an in-house smartphone application, PsyHub. Study 1 and 2 will follow the CONSORT and STROBE guidelines, respectively. The current registration is only for Study 1 of the current research project.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Adults aged 18 to 65 years living in Hong Kong
•Being fluent and literate in Cantonese
•A Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms
•Accessibility to an Internet-enabled mobile device (iOS or Android operating system)
•Willingness to provide informed consent and comply with the trial protocol.
•Adults aged 18-65 years living in Hong Kong
•Being fluent and literate in Cantonese
•A PHQ-9 score of at least 10, indicating a moderate level of depression.
•Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
•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)
+2 more criteria

Exclusion Criteria

•Presence of any psychiatric disorder(s) as assessed by MINI
•Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
•Presence of other untreated sleep disorders based on cut-off scores of individual sections in SLEEP-50.
•We will not exclude those with current suicidal risks (i.e., non-fleeting intent or plan), which is a common symptom of MDD. However, if serious suicidal risk (i.e., PHQ-9 Item 9 score \> 2) is identified, the participant will be referred to the PI (a clinical psychologist) for further assessment and professional mental health services if deemed necessary.
•Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
•Presence of other psychiatric disorders as assessed by MINI
•A history of electroconvulsive therapy (ECT)
•Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems
•A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment
•Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
+1 more criteria

Locations (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Key Dates

Start Date

June 1, 2024

Primary Completion Date

October 1, 2025

Completion Date

January 1, 2026

Last Updated

May 22, 2024

Enrollment

140

ESTIMATED participants

Conditions

DepressionSleep Disorders, Circadian Rhythm

Interventions

No intervention involved

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy

Inclusion Criteria

Exclusion Criteria

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