[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480219":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":53,"locations":58,"responsibleParty":75,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":36,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":36,"enrollmentInfo":91,"targetDuration":36,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":61,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,15,20,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Assessment form allocated by chance & guided ICBT for antenatal depression","ACTIVE_COMPARATOR","Patients are randomized to assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \\& and are randomised to treatment with internet-CBT for antenatal depression without extra-support (10 weeks)",[13,14],"Behavioral: Therapist Guided Internet-CBT for antenatal depression","Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance",{"label":16,"type":10,"description":17,"interventionNames":18},"Assessment form allocated by choice & guided ICBT for antenatal depression","Patients choose assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \\& are randomised to treatment with internet-CBT for antenatal depression without extra-support (10 weeks)",[13,19],"Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice",{"label":21,"type":22,"description":23,"interventionNames":24},"Assessment form allocated by chance & guided ICBT for antenatal depression with extra support","EXPERIMENTAL","Patients are randomized to assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \\& and are randomised to treatment with internet-CBT for antenatal depression with extra-support",[25,14],"Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.",{"label":27,"type":22,"description":28,"interventionNames":29},"Assessment form allocated by choice & guided ICBT for antenatal depression with extra support","Patients choose assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \\& are randomised to treatment with internet-CBT for antenatal depression with extra-support (10 weeks)",[25,19],[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BEHAVIORAL","Therapist Guided Internet-CBT for antenatal depression","A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression.",[9,16],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.","A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression. Additionally, up to three supportive contacts with a midwife or perinatal mental health nurse to support ICBT treatment and adress general pregnancy related health problems.",[21,27],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Diagnostic assessment by telephone, video or face-to face - Allocation by chance","Structured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation by chance.",[9,21],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Diagnostic assessment by telephone, video or face-to face - Allocation by choice","Structured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation based on patient preference.",[16,27],[50],{"name":51,"affiliation":5,"role":52},"Marie Bendix, PhD","PRINCIPAL_INVESTIGATOR",[54],{"name":51,"role":55,"phone":56,"phoneExt":36,"email":57},"CONTACT","+46 73 6370 864","marie.bendix@ki.se",[59],{"facility":60,"status":61,"city":62,"state":36,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry","RECRUITING","Stockholm","141 86","Sweden","SE",{"type":67,"coordinates":68},"Point",[69,70],18.06871,59.32938,{"lat":70,"lon":69},[73],{"name":51,"role":55,"phone":74,"phoneExt":36,"email":57},"+46 73 637 0864",{"type":52,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Marie Bendix","Principal investigator",[79],{"name":80,"class":81},"Region Stockholm","OTHER_GOV","100480219","internet-cbt-for-antenatal-depression-100480219",false,"NCT05533138","Internet CBT for Antenatal Depression","Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.","Inclusion Criteria:\n\n* Mild to moderate major depression\n* Pregnant at treatment start\n* Regular contact with maternity mental health clinic\n* \\> 18 years old\n* Being able to start the treatment earliest in gestational week 8 and latest in gestational week 30\n* Stable medication for depression and\u002For other psychiatric conditions for at least 3 weeks.\n* Being able to participate in the treatment during the treatment time and having access to and being able to use the internet and mobile phone during the treatment time\n* Being able to understand the Swedish language orally and in writing\n\nExclusion Criteria:\n\n* Montgomery-Åsberg Depression Rating Scale-Self report version (MADRS-S) score below 15 (symptoms of depression to low) or above 35 (severe depression)\n* High risk of self harm or suicide (based on semi-structured clinical suicide risk assessment)\n* Psychiatric comorbidity, disability, somatic disorder, or pregnancy complications that prevent treatment participation or that can be negatively affected or compose a risk for the fetus by treatment participation\n* Ongoing psychological treatment with similar content","FEMALE","18 Years",{"count":92,"type":93},415,"ESTIMATED","INTERVENTIONAL",[96],"NA","Pregnant women in pregnancy week 8-29 screening positive for antenatal depression will be randomized to either choose or to be allotted by chance to different forms of diagnostic assessment; i.e. telephone, video or face-to-face assessment.\n\nThose diagnosed with mild to moderate major depression will then be randomized to treatment with therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for women suffering from antenatal depression or to the same treatment with addition of up to three contacts with extra support by a midwife or experienced perinatal mental health nurse.\n\nThe primary aim is to assess whether extrasupport in addition to internet-guided pregnancy adapted ICBT decreases depressive symptoms more than internet-guided pregnancy adapted ICBT only. Secondary aims include effects of extrasupport and assessment mode on treatment satisfaction, fidelity and credibility.",[99],"Antenatal Depression",[101,102,103,104],"Cognitive behavior therapy","Internet treatment","Self-help treatment","Perinatal support","2024-06-24",{"date":107,"type":108},"2024-06-25","ACTUAL",{"date":110,"type":108},"2021-02-25",{"date":112,"type":93},"2027-12-31",{"name":5,"class":6},1]