Nctid:
NCT06233422
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012893", "term"=>"Sleep Wake Disorders"}, {"id"=>"D000020178", "term"=>"Sleep Disorders, Circadian Rhythm"}, {"id"=>"D000003863", "term"=>"Depression"}], "ancestors"=>[{"id"=>"D000001526", "term"=>"Behavioral Symptoms"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000021081", "term"=>"Chronobiology Disorders"}, {"id"=>"D000020920", "term"=>"Dyssomnias"}, {"id"=>"D000009784", "term"=>"Occupational Diseases"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "asFound"=>"Depression", "relevance"=>"HIGH"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "relevance"=>"LOW"}, {"id"=>"M7060", "name"=>"Depressive Disorder, Major", "relevance"=>"LOW"}, {"id"=>"M22242", "name"=>"Parasomnias", "relevance"=>"LOW"}, {"id"=>"M22007", "name"=>"Sleep Disorders, Circadian Rhythm", "asFound"=>"Sleep Disorders, Circadian Rhythm", "relevance"=>"HIGH"}, {"id"=>"M15696", "name"=>"Sleep Wake Disorders", "asFound"=>"Sleep Disorders", "relevance"=>"HIGH"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M22703", "name"=>"Chronobiology Disorders", "relevance"=>"LOW"}, {"id"=>"M22655", "name"=>"Dyssomnias", "relevance"=>"LOW"}, {"id"=>"M12719", "name"=>"Occupational Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Occupational Diseases", "abbrev"=>"BC24"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>140}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-06", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2026-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-21", "studyFirstSubmitDate"=>"2024-01-14", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-22", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in Patient Health Questionnaire-9 (PHQ-9)", "timeFrame"=>"1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1", "description"=>"A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression, by scoring each item from \"0\" (not at all) to \"3\" (nearly everyday), total severity scale ranging from 0 to 27."}, {"measure"=>"Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep onset latency (SOL)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SOL is one of the sleep parameters which will be measured by Actigraphy."}, {"measure"=>"Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - wake after sleep onset (WASO)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, WASO is one of the sleep parameters which will be measured by Actigraphy."}, {"measure"=>"Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - total sleep time (TST)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TST is one of the sleep parameters which will be measured by Actigraphy."}, {"measure"=>"Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep efficiency (SE)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SE is one of the sleep parameters which will be measured by Actigraphy."}, {"measure"=>"Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - fragmentation index (FI)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, FI is one of the sleep parameters which will be measured by Actigraphy."}, {"measure"=>"Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - time in bed (TIB)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TIB is one of the sleep parameters which will be measured by Actigraphy."}, {"measure"=>"Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - number of awakenings (NOA)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, NOA is one of the sleep parameters which will be measured by Actigraphy."}, {"measure"=>"Variability in sleep-wake variables using non-parametric approach - interdaily stability (IS)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"IS is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach."}, {"measure"=>"Variability in sleep-wake variables using non-parametric approach - intradaily variability (IV)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"IV is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach."}, {"measure"=>"Variability in sleep-wake variables using non-parametric approach - relative amplitude (RA)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"RA is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach."}, {"measure"=>"Variability in sleep-wake variables using non-parametric approach - the least active 5 hours (L5)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"L5 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach."}, {"measure"=>"Variability in sleep-wake variables using non-parametric approach - the most active 10 hours (M10)", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"M10 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach."}, {"measure"=>"Variability in sleep-wake variables using extended cosinor approach - amplitude", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Rhythm height (amplitude) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the difference between the peak and nadir of the rhythm."}, {"measure"=>"Variability in sleep-wake variables using extended cosinor approach - mesor", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Rhythm height (mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the 24-hour adjusted mean rhythm activity,"}, {"measure"=>"Variability in sleep-wake variables using extended cosinor approach - acrophase", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Rhythm timing (acrophase) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the time of peak rhythm activity."}, {"measure"=>"Variability in sleep-wake variables using extended cosinor approach - up-mesor", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Rhythm timing (up-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the activity initiation time."}, {"measure"=>"Variability in sleep-wake variables using extended cosinor approach - down-mesor", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Rhythm timing (down-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the time of activity offset."}, {"measure"=>"Variability in sleep-wake variables using extended cosinor approach - alpha", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Rhythm shape (alpha) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the width of the rhythm."}, {"measure"=>"Variability in sleep-wake variables using extended cosinor approach - beta", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Rhythm shape (beta) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the steepness of the fitted curve."}, {"measure"=>"Variability in sleep-wake variables using extended cosinor approach - pseudo F-statistic", "timeFrame"=>"24-hour wear time for 4 consecutive weeks", "description"=>"Rhythm robustness (pseudo F-statistic) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the goodness of extended cosine fit."}], "secondaryOutcomes"=>[{"measure"=>"Change in Hospital Anxiety and Depression Scale (HADS)", "timeFrame"=>"1 at baseline, and 1 at the end of study 1", "description"=>"A 14-item scale measuring anxiety and depression in both hospital and community settings."}, {"measure"=>"Change in Insomnia Severity Index (ISI)", "timeFrame"=>"1 at baseline, and 1 at the end of study 1", "description"=>"A 7-item scale used to assess the perceived severity of insomnia."}, {"measure"=>"Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)", "timeFrame"=>"1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1", "description"=>"8-item scales to assess sleep and circadian functions."}, {"measure"=>"Change in Multidimensional Fatigue Inventory (MFI)", "timeFrame"=>"1 at baseline, and 1 at the end of study 1", "description"=>"A 20-item scale used to assess five dimensions of fatigue."}, {"measure"=>"Change in Short Form (6-Dimension) Health Survey (SF-6D)", "timeFrame"=>"1 at baseline, and 1 at the end of study 1", "description"=>"A health survey used for measuring the quality of life on six dimensions."}, {"measure"=>"Change in Sheehan Disability Scale (SDS)", "timeFrame"=>"1 at baseline, and 1 at the end of study 1", "description"=>"A 5-item scale used to assess functional impairments in work/ school, social life, and family life."}, {"measure"=>"Change in Core Consensus Standardized Sleep Diary", "timeFrame"=>"4-week daily survey", "description"=>"A 9-item scale used to record sleep time, wake time, perceived sleeping quality, and use of hypnotics."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Actigraphy", "Transdiagnostic Intervention", "Depression", "Rest-Activity Rhythm"], "conditions"=>["Depression", "Sleep Disorders, Circadian Rhythm"]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nIn 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.\n\nStudy 1 and 2 will follow the CONSORT and STROBE guidelines, respectively. The current registration is only for Study 1 of the current research project."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Community sample, if recruitment in the community is insufficient, we will recruit participants from our collaborating outpatient clinics, non-governmental organizations, and community centers", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria for Healthy Control Group:\n\n* Adults aged 18 to 65 years living in Hong Kong\n* Being fluent and literate in Cantonese\n* A Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms\n* Accessibility to an Internet-enabled mobile device (iOS or Android operating system)\n* Willingness to provide informed consent and comply with the trial protocol.\n\nExclusion Criteria for Healthy Control Group:\n\n* Presence of any psychiatric disorder(s) as assessed by MINI\n* Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns\n* Presence of other untreated sleep disorders based on cut-off scores of individual sections in SLEEP-50.\n\nWe 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.\n\nInclusion Criteria for the Major Depressive Disorder (MDD) group:\n\n* Adults aged 18-65 years living in Hong Kong\n* Being fluent and literate in Cantonese\n* A PHQ-9 score of at least 10, indicating a moderate level of depression.\n* Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)\n* 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)\n* Access to an Internet-enabled mobile device (iOS or Android operating system)\n* Willingness to provide informed consent and comply with the trial protocol.\n\nExclusion Criteria for the Major Depressive Disorder (MDD) group:\n\n* Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience\n* Presence of other psychiatric disorders as assessed by MINI\n* A history of electroconvulsive therapy (ECT)\n* Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems\n* A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment\n* Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns\n* 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)"}, "identificationModule"=>{"nctId"=>"NCT06233422", "briefTitle"=>"Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy", "organization"=>{"class"=>"OTHER", "fullName"=>"Chinese University of Hong Kong"}, "officialTitle"=>"Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder", "orgStudyIdInfo"=>{"id"=>"PSY033"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Major Depressive Disorder (MDD) Group", "description"=>"MDD group will consist of 70 participants with MDD, aged between 18-65, with a Patient Health Questionnaire-9 (PHQ-9) score of at least 10; who are also experiencing at least 1 sleep or circadian problem in the past 3 months.", "interventionNames"=>["Other: No intervention involved"]}, {"label"=>"Healthy Control Group", "description"=>"Healthy control group will consist of 70 healthy control participants, aged between 18-65, with a Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms.", "interventionNames"=>["Other: No intervention involved"]}], "interventions"=>[{"name"=>"No intervention involved", "type"=>"OTHER", "description"=>"No intervention involved", "armGroupLabels"=>["Healthy Control Group", "Major Depressive Disorder (MDD) Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Sha Tin", "country"=>"Hong Kong", "facility"=>"The Chinese University of Hong Kong", "geoPoint"=>{"lat"=>22.38333, "lon"=>114.18333}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Chinese University of Hong Kong", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor", "investigatorFullName"=>"Fiona YY Ho", "investigatorAffiliation"=>"Chinese University of Hong Kong"}}}}
