[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575123":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":37,"locations":43,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":36,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":46,"whyStopped":36,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group 1","EXPERIMENTAL","In intervention group 1, pregnant women and their partners will participate in a six-week Welove intervention. The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation.",[13],"Behavioral: WhatsApp-based psycho-socio-educational intervention (WeLove)",{"label":15,"type":10,"description":16,"interventionNames":17},"Intervention group 2","In intervention group 2, only pregnant women will participate in a six-week WeLove intervention. The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Control","PLACEBO_COMPARATOR","In the control group, pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.",[23],"Behavioral: WhatsApp as usual",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","WhatsApp as usual","Pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.",[19],[31],"WhatsApp for couple",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"WhatsApp-based psycho-socio-educational intervention (WeLove)","The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation. Each session has two short videos, quizzes, forums, and homework. The content is presented through a virtual midwife using storytelling of real-life scenarios, animation, and case vignettes about psychological and sleep problems during pregnancy. A virtual midwife acts as an educator to explain the prevalence, causes, and factors of psychological and sleep problems. Every session will concentrate on certain courses and offer specialised advice to expectant mothers and their partners. Using the security links on the WhatsApp platform, each session takes 15 to 20 minutes to finish.",[9,15],null,[38],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"Ying Lau, PhD","CONTACT","(852) 39436222","yinglau@cuhk.edu.hk",[44],{"facility":45,"status":46,"city":47,"state":36,"zip":36,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Chinese University of Hong Kong","RECRUITING","Hong Kong","HK",{"type":50,"coordinates":51},"Point",[52,53],114.17469,22.27832,{"lat":53,"lon":52},[56],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Lau Ying","Professor",[62],{"name":63,"class":64},"Hospital Authority, Hong Kong","OTHER_GOV","100575123","whatsapp-based-psycho-socio-educational-intervention-welove-for-prevention-of-psychological-and-sleep-problems-in-pregnant-women-and-their-partners-a-three-arm-double-blinded-pilot-randomised-controlled-trial-100575123",false,"NCT06768190","WhatsApp-based Psycho-socio-educational Intervention (WeLove) for Prevention of Psychological and Sleep Problems in Pregnant Women and Their Partners: A Three-arm Double-blinded Pilot Randomised Controlled Trial","WhatsApp-based","Inclusion Criteria:\n\n* pregnant with a gestation of \\>12 to 28 weeks and their partners over 18 years\n* able to read and understand Chinese\n* have electronic devices with WhatsApp that can contact the Internet\n* can provide written consent and voluntary participation in this study\n\nExclusion Criteria:\n\n* current severe medical illnesses\n* psychological and sleep disorders",true,"ALL","18 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"NA","Objectives: (1) evaluate the feasibility and acceptability of the WhatsApp-based psycho-socio-educational intervention (WeLove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners.\n\nMethods: The investigators will use WhatsApp to provide the six sessions of the intervention, which include psychological, social, and educational components. A three-arm double-blinded pilot randomised controlled trial (RCT) is used in 60 couples, followed by individual face-to-face interviews for process evaluation in 10 to 20 couples based on data saturation. Participants will be assigned to one of three groups and 20 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WhatsApp as normal). Participants will be assessed pre- and post-intervention. Generalised estimating equation analysis and thematic analysis will be performed to examine the research objectives.",[83,84,85],"Sleep Problems","Psychological","Well-Being, Psychological",[87,88,89,90],"Couple-based intervention","Psycho-socio-educational intervention (WeLove)","Psychological well-being","Sleep outcome","2025-01-21",{"date":93,"type":94},"2025-01-23","ACTUAL",{"date":96,"type":94},"2025-01-06",{"date":98,"type":77},"2027-01-31",{"name":5,"class":6},1]