Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT04350333
Status:
UNKNOWN
Last Update Posted:
2021-04-27
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Digital CBT-I Intervention During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Follow up: 2 weeks post partum', 'description': 'Depression symptomatology (Edinburgh Postnatal Depression Scale - EPDS). Scoring: \\< 8: depression not likely; 9-11: depression possible; 12-13:Fairly high possibility of depression; \\> 14 probable depression'}, {'measure': 'Depression', 'timeFrame': 'Follow up: 3 months post partum', 'description': 'Depression symptomatology (Edinburgh Postnatal Depression Scale - EPDS). Scoring: \\< 8: depression not likely; 9-11: depression possible; 12-13:Fairly high possibility of depression; \\> 14 probable depression'}, {'measure': 'Depression', 'timeFrame': 'Follow up: 6 months post partum', 'description': 'Depression symptomatology (Edinburgh Postnatal Depression Scale - EPDS). Scoring: \\< 8: depression not likely; 9-11: depression possible; 12-13:Fairly high possibility of depression; \\> 14 probable depression'}, {'measure': 'Anxiety', 'timeFrame': 'Follow up: 2 weeks post partum', 'description': 'Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.'}, {'measure': 'Anxiety', 'timeFrame': 'Follow up: 3 months post partum', 'description': 'Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.'}, {'measure': 'Anxiety', 'timeFrame': 'Follow up: 6 months post partum', 'description': 'Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)', 'timeFrame': 'Post intervention: after 5 weeks from the start of intervention', 'description': 'sleep pattern derived from sleep diaries'}, {'measure': 'insomnia symptoms', 'timeFrame': 'Post intervention: after 5 weeks from the start of intervention', 'description': 'Insomnia severity index scores (ISI). Scoring: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)'}, {'measure': 'Emotion regulation', 'timeFrame': 'Post intervention: after 5 weeks from the start of intervention', 'description': 'Emotion Regulation Questionnaire (ERQ) - Higher scores mean better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia in Pregnancy']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the efficacy of Cognitive Behavioral Therapy for Insomnia in pregnant women. Particularly, this study aim to explore the effect of this intervention in ameliorating insomnia symptoms and in preventing post-partum depression disorder. The experimental intervention is a digital CBT-I and the control intervention group is an assertive communication training. Both interventions include a screening phase and will be delivered in a digital way and will be composed of 5 sessions. Furthermore, both interventions protocol include a baseline, half time and follow up assessments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnancy\n* Women that not consume nicotine or alcool\n* BMI \\< 30\n* Women who complains of insomnia or bad sleep quality\n\nExclusion Criteria:\n\n* BMI\\> 30\n* Complicated pregnancy\n* Women who consume nicotine or alcool'}, 'identificationModule': {'nctId': 'NCT04350333', 'briefTitle': 'Efficacy of Digital CBT-I Intervention During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome G. Marconi'}, 'officialTitle': 'Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention During Pregnancy in Prevention of Post-partum Depression: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'UMarconi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-I group', 'description': "Five sessions composed of: psychoeducation on sleep change during pregnancy and postpartum; sleep hygiene principles; stimulus control technique, sleep restriction technique (f this technique will be too difficult for the participants to be apply, a replacement and less disabling technique will be applied: sleep compression); psychoeducation on the child's sleep at birth and on the change in the sleep-wake cycle in the early stages of the child's life; cognitive control technique; cognitive reconstruction technique and de-catastrophization; relapses prevention.", 'interventionNames': ['Behavioral: CBT-I']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Assertive communication training', 'description': 'Five sessions composed of: psychoeducation and explanation of the importance of emotional and cognitive factors for good sleep. Psychoeducation about the concept of assertiveness, explanation of the passive, aggressive and assertive style; explanation and exercises regarding self-esteem and positive self-image; explanation of the development of sleep of the child in the first years of life; explanation and exercises on the phase of the management of feedback and requests; conflict management; relapses prevention.', 'interventionNames': ['Behavioral: Assertive communication training']}], 'interventions': [{'name': 'CBT-I', 'type': 'BEHAVIORAL', 'description': 'Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.', 'armGroupLabels': ['CBT-I group']}, {'name': 'Assertive communication training', 'type': 'BEHAVIORAL', 'description': 'Intervention based on improving assertive communication and regulating emotions.', 'armGroupLabels': ['Assertive communication training']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome G. Marconi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Valeria Bacaro', 'investigatorAffiliation': 'University of Rome G. Marconi'}}}}