Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181110
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2023-12-13
Brief Title:
Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 featuresprofiles 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 featuresprofiles 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 11 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 chargeThe current registration is only for Study 2 of the current research project
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None