[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545221":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":53,"responsibleParty":113,"collaborators":116,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":24,"enrollmentInfo":131,"targetDuration":24,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":56,"whyStopped":24,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"University of Rome G. Marconi","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Subgroup B2: CBT-I derived intervention","EXPERIMENTAL","CBT-I derived intervention: 6 weekly online sessions with psychoeducation on sleep adapted to pregnancy, introduction of CBT-I techniques, discussion of sleep diaries and of acquired skills.",[13],"Behavioral: Improving sleep health and resilience during pregnancy",{"label":15,"type":16,"description":17,"interventionNames":18},"Subgroup B1: psychological placebo intervention","PLACEBO_COMPARATOR","Psychoeducation placebo control intervention: 6 weekly online sessions composed of educational videos (ca. 20 minutes) on aspects related to pregnancy and sleep.",[19],"Behavioral: Information on pregnancy-related issues",{"label":21,"type":22,"description":23,"interventionNames":24},"Group A: control group","NO_INTERVENTION","A control group of healthy pregnant women with no insomnia complaints (ISI \\\u003C 8) will be followed parallel to the intervention and control group, from the first trimester of pregnancy to 6 months post-partum to assess changes in sleep and psychological indices in pregnancy.",null,[26,33],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Improving sleep health and resilience during pregnancy","Weekly sessions include: a video clip (ca. 20 min) and a pdf; short questions on participants' experience related to the session's content; brief feedback questions on session's contents. Participants will have weekly opportunity for private online chats with a clinician.\n\nSessions' contents:\n\n1. Aims of the intervention; introducing the physiological regulation of sleep, sleep health and how sleep changes during pregnancy;\n2. Psychological regulation of sleep and the impact of behaviors on sleep regulation; introducing the basics of CBT-I behavioral techniques;\n3. Cognitive factors maintaining sleep difficulties; introducing cognitive techniques;\n4. Emotional factors maintaining sleep difficulties and on the bidirectional association between sleep and emotions; introducing emotion regulation techniques;\n5. Sleep in the postpartum and the development of sleep regulation in children;\n6. Relapse prevention and focus on acquired skills and how to prioritize sleep.",[9],[32],"Sleeping for…2. Taking care of sleep during pregnancy and the post-partum",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Information on pregnancy-related issues","Each session will include: video clip (ca. 20 minutes) on aspects related to pregnancy and sleep; brief feedback questions. Participants in the placebo intervention will not be given specific indications on skills or techniques for sleep difficulties and will not have access to the weekly chat with the clinician.\n\nSessions will cover the following contents:\n\nSession 1: phases of pregnancy; Session 2: sleep disorders; Session 3: nutrition and physical activity during pregnancy; Session 4: childbirth; Session 5: psychophysical development of the child in the first three years of life; Session 6: synthesis of previous sessions.",[15],[38],"Getting to know pregnancy ... pregnancy and postpartum information meetings",[40],{"name":41,"affiliation":42,"role":43},"Chiara Baglioni, Professor","Department of Human Sciences, Guglielmo Marconi University, Rome, Italy","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":24,"email":49},"Chiara Baglioni, PhD","CONTACT","06377251","c.baglioni@unimarconi.it",{"name":51,"role":47,"phone":48,"phoneExt":24,"email":52},"Debora Meneo, M.Sc","d.meneo@unimarconi.it",[54,98],{"facility":55,"status":56,"city":57,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy","RECRUITING","Bologna","40126","Italy","IT",{"type":62,"coordinates":63},"Point",[64,65],11.33875,44.49381,{"lat":65,"lon":64},[68,71,72,74,77,79,81,83,85,87,89,91,93,95,96],{"name":69,"role":47,"phone":24,"phoneExt":24,"email":70},"Viviana Lo Martire","viviana.lomartire2@unibo.it",{"name":51,"role":47,"phone":48,"phoneExt":24,"email":52},{"name":51,"role":73,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"name":75,"role":76,"phone":24,"phoneExt":24,"email":24},"Elisabetta Baldi, M.Sc","SUB_INVESTIGATOR",{"name":78,"role":76,"phone":24,"phoneExt":24,"email":24},"Silvia Cerolini, PhD",{"name":80,"role":76,"phone":24,"phoneExt":24,"email":24},"Viviana Lo Martire, PhD",{"name":82,"role":76,"phone":24,"phoneExt":24,"email":24},"Giuliana Simonazzi, PhD",{"name":84,"role":76,"phone":24,"phoneExt":24,"email":24},"Sara Curati, B.Sc",{"name":86,"role":76,"phone":24,"phoneExt":24,"email":24},"Stefano Bastianini, PhD",{"name":88,"role":76,"phone":24,"phoneExt":24,"email":24},"Chiara Berteotti, PhD",{"name":90,"role":76,"phone":24,"phoneExt":24,"email":24},"Mauro Manconi, PhD",{"name":92,"role":76,"phone":24,"phoneExt":24,"email":24},"Giovanna Zoccoli, PhD",{"name":94,"role":76,"phone":24,"phoneExt":24,"email":24},"Francesca Gelfo, PhD",{"name":46,"role":73,"phone":24,"phoneExt":24,"email":24},{"name":97,"role":76,"phone":24,"phoneExt":24,"email":24},"Paola De Bartolo, PhD",{"facility":99,"status":56,"city":100,"state":100,"zip":101,"country":59,"countryCode":60,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Department of Human Sciences, Guglielmo Marconi university","Rome","00193",{"type":62,"coordinates":103},[104,105],12.51133,41.89193,{"lat":105,"lon":104},[108,111],{"name":109,"role":47,"phone":48,"phoneExt":110,"email":49},"Chiara Baglioni, PhD, Associate Professor","+39",{"name":112,"role":47,"phone":24,"phoneExt":24,"email":52},"Debora Meneo, PhD",{"type":73,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Chiara Baglioni","Professor",[117,119],{"name":118,"class":6},"University of Bologna",{"name":120,"class":6},"University of the Italian Switzerland","100545221","poor-sleep-during-pregnancy-as-risk-factor-for-post-partum-stress-and-mental-health-100545221",false,"NCT06379074","Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health","Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health: A Translational, Longitudinal and Clinical Study. Maternal Outcome After THERapy for Sleep (MOTHERS)","MOTHERS","Inclusion Criteria:\n\n1. age ≥ 18 yrs. old;\n2. good knowledge of Italian language;\n3. intention to continue pregnancy;\n4. BMI ranging 18-30 (i.e., without underweight or obesity following international criteria; WHO, 2013);\n5. ≤ 15th week of pregnancy at the time of recruitment.\n\nExclusion Criteria:\n\n1. severe diagnosis of relevant somatic disorder;\n2. smoking;\n3. alcohol intake;\n4. assumption of illegal drugs;","FEMALE","18 Years",{"count":132,"type":133},114,"ESTIMATED","INTERVENTIONAL",[136],"NA","Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes.",[139,140,141],"Postpartum Depression","Insomnia","Stress",[140,143,141,144,145,146,147,148,149],"Pregnancy","Sleep health","Postpartum","Actigraphy","Cortisol","DNA methylation","CBT-I","2026-02-26",{"date":152,"type":153},"2026-03-02","ACTUAL",{"date":155,"type":153},"2024-05-06",{"date":157,"type":133},"2026-10-06",{"name":5,"class":6},2]