Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in Patient Health Questionnaire-9 (PHQ-9)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Fiona YY Ho
Associate Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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 Outcomes
- Change in Sheehan Disability Scale (SDS)(Baseline, and immediate post treatment assessment)
- Change in Hospital Anxiety and Depression Scale (HADS)(Baseline, and immediate post treatment assessment)
- Change in Insomnia Severity Index (ISI)(Baseline, and immediate post treatment assessment)
- 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)
- Change in Multidimensional Fatigue Inventory (MFI)(Baseline, and immediate post treatment assessment)
- Change in Short Form (6-Dimension) Health Survey (SF-6D)(Baseline, and immediate post treatment assessment)
- Change in Core Consensus Standardized Sleep Diary(10-week daily survey)