protocolSection identificationModule nctId: NCT06379074, orgStudyIdInfo id: 2022PMFMSE, secondaryIdInfos id: C53D23004250008, type: OTHER_GRANT, domain: Italian Ministry of University and Research (MUR), briefTitle: Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health, acronym: MOTHERS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-08-06, completionDateStruct date: 2025-10-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Rome G. Marconi, class: OTHER, collaborators name: University of Bologna, collaborators name: University of the Italian Switzerland, descriptionModule briefSummary: 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., conditionsModule conditions: Postpartum Depression, conditions: Insomnia, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will receive a personal e-mail address to access their reserved area of the study's website. Each e-mail address is created using the pre-defined pseudonymized code, which will be assigned to each participant after screening (participants with sleep difficulties will be randomly assigned a code for condition B1 or B2).This procedure is designed to increase privacy protection, allow for matching of responses throughout study's phases, and blind outcome assessors to participants allocation.The personal website areas include contents based on their group allocation:* A: online questionnaire and sleep diaries;* B1: online questionnaire and sleep diaries; placebo intervention's contents (videos and pdf);* B2: online questionnaire and sleep diaries; intervention's contents (videos and pdf); weekly optional private chat with a clinician (a psychotherapist expert in CBT-I and insomnia during pregnancy)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The codes associated to participants in Group B will be randomly assigned to intervention (Group B2) or placebo (Group B1). E-mail addresses will be created for each participant using the ID-code to access the private area of the study website. The code will be associated with responses to online questionnaires, actigraphy recording, saliva samples and sleep diaries., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Improving sleep health and resilience during pregnancy, interventions name: Information on pregnancy-related issues, outcomesModule primaryOutcomes measure: Stress reactivity, primaryOutcomes measure: Sleep efficiency, primaryOutcomes measure: Depressive symptoms, primaryOutcomes measure: Insomnia symptoms, primaryOutcomes measure: Anxiety symptoms, primaryOutcomes measure: Valence of affective states, primaryOutcomes measure: Arousal of affective states, primaryOutcomes measure: Emotion regulation, secondaryOutcomes measure: Mothers' parenting stress, secondaryOutcomes measure: Partners' insomnia symptoms, secondaryOutcomes measure: Children sleep difficulties, otherOutcomes measure: Partners' sleep efficiency, otherOutcomes measure: Fathers' parenting stress, otherOutcomes measure: Daytime sleepiness, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy, city: Bologna, zip: 40126, country: Italy, contacts name: Viviana Lo Martire, role: CONTACT, email: viviana.lomartire2@unibo.it, contacts name: Debora Meneo, M.Sc, role: CONTACT, phone: 06377251, email: d.meneo@unimarconi.it, contacts name: Debora Meneo, M.Sc, role: PRINCIPAL_INVESTIGATOR, contacts name: Elisabetta Baldi, M.Sc, role: SUB_INVESTIGATOR, contacts name: Silvia Cerolini, PhD, role: SUB_INVESTIGATOR, contacts name: Viviana Lo Martire, PhD, role: SUB_INVESTIGATOR, contacts name: Giuliana Simonazzi, PhD, role: SUB_INVESTIGATOR, contacts name: Sara Curati, B.Sc, role: SUB_INVESTIGATOR, contacts name: Stefano Bastianini, PhD, role: SUB_INVESTIGATOR, contacts name: Chiara Berteotti, PhD, role: SUB_INVESTIGATOR, contacts name: Mauro Manconi, PhD, role: SUB_INVESTIGATOR, contacts name: Giovanna Zoccoli, PhD, role: SUB_INVESTIGATOR, contacts name: Francesca Gelfo, PhD, role: SUB_INVESTIGATOR, contacts name: Chiara Baglioni, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Paola De Bartolo, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False