Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 6:18 AM
Study NCT ID:
NCT06405932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Intervention Effect of Self-help Training Camps in Promoting Mental Health Among Perinatal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2024-05-05', 'studyFirstSubmitQcDate': '2024-05-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edinburgh Postnatal Depression Scale', 'timeFrame': '0, 3 weeks, 42 days postpartum', 'description': 'The scale is employed to assess the severity of depression and comprises 10 items, each of which is scored on a 0 to 3 point scale. A total score of 0 to 9 indicates a negative result, 10 to 12 indicates mild depression, 13 to 16 indicates moderate depression, and a score greater than or equal to 17 indicates severe depression.'}, {'measure': 'Generalized Anxiety Disorder', 'timeFrame': '0, 3 weeks, 42 days postpartum', 'description': 'The scale is designed to assess the severity of an individual\\'s anxiety symptoms over the past two weeks. It comprises seven entries, each rated on a scale of 0 to 3. A total score of 5 to 9 is indicative of mild anxiety, 10 to 14 of moderate anxiety, and a score of 15 or above of severe anxiety.'}], 'secondaryOutcomes': [{'measure': 'Maternal and infant endings', 'timeFrame': '42 days postpartum', 'description': 'Maternal pregnancy outcomes and general neonatal outcomes were collected via self-administered scales.'}, {'measure': 'World Health Organization Five-item Well-Being Index', 'timeFrame': '0, 3 weeks, 42 days postpartum', 'description': 'The scale in question assesses well-being, with higher total scores representing higher levels of well-being.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health', 'Perinatal Depression']}, 'descriptionModule': {'briefSummary': 'This study was a multi-center randomized controlled trial of an Internet-based self-help mental fitness training camp intervention that included women in early, mid, and late pregnancy with or without psychological distress. A comparison was conducted between the intervention and control groups with regard to depression and anxiety scores during pregnancy and at 42 days postpartum in order to ascertain the efficacy of a self-help mental fitness training camp in preventing negative emotions among perinatal women. In addition, associations between different modes of intervention and maternal and infant outcomes were investigated.', 'detailedDescription': 'In this study, the principle of "early detection, early diagnosis and early treatment" was used to screen and manage negative emotions such as anxiety and depression in three time windows: early pregnancy, mid-pregnancy and late pregnancy. All weeks from June to December 2024 were randomly divided into intervention and control weeks. Pregnant women were assigned to the intervention or control group according to the week of their visit to the hospital for obstetric examination. The intervention group of pregnant women participated in a three-week program of mental fitness training, while the control group received standard care.\n\nThe participants were evaluated on multiple occasions following their enrollment in the study. These evaluations occurred at the baseline stage, immediately following the intervention, during the mid and late stages of pregnancy, and 42 days after delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n* The gestational week in early pregnancy is 0 to 13 weeks; the gestational week in mid-pregnancy is 14 to 27 weeks; and the gestational week in late pregnancy is 28 to 32 weeks.\n* Intention to have children in this pregnancy.\n* Ability to understand and complete the questionnaire independently.\n* Informed consent and voluntary participation in this study.\n\nExclusion Criteria:\n\n* Suffering from depression being treated with psychotherapy or medication.\n* The presence of a serious mental illness or intellectual disability.'}, 'identificationModule': {'nctId': 'NCT06405932', 'briefTitle': 'Study of the Intervention Effect of Self-help Training Camps in Promoting Mental Health Among Perinatal Women', 'organization': {'class': 'OTHER', 'fullName': 'Anhui Medical University'}, 'officialTitle': 'A Multi-center Randomized Controlled Trial : Study of the Intervention Effect of "a Self-help Mental Fitness Training Camp"on Depression Symptoms During Pregnancy', 'orgStudyIdInfo': {'id': '202451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mental Fitness Training Camp', 'description': 'The self-help mental fitness training camp, comprising 21 learning modules structured around animated thinking videos, audio, text, and moving images, lasts 21 days. Each learning module is automatically pushed to the intervention group on a daily basis, with an estimated completion time of 30-50 minutes.', 'interventionNames': ['Combination Product: Mental Fitness Training Camp']}, {'type': 'NO_INTERVENTION', 'label': 'health education', 'description': 'The control group received routine-care'}], 'interventions': [{'name': 'Mental Fitness Training Camp', 'type': 'COMBINATION_PRODUCT', 'description': 'The Mental Fitness Training camp employs and incorporates core learning content derived from Cognitive Behavioral Therapy and Mindfulness. The program comprises nine thought animations, emotional diary, daily breathing exercises, and pleasure lists.', 'armGroupLabels': ['Mental Fitness Training Camp']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fangbiao Tao, Professor', 'role': 'CONTACT', 'email': 'taofangbiao@126.com', 'phone': '+86 13856986775'}, {'name': 'Fangbiao Fangbiao Tao, Professor', 'role': 'CONTACT', 'email': 'taofangbiao@126.com', 'phone': '+86 13856986775'}], 'overallOfficials': [{'name': 'Chengli Tang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Anhui Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fangbiao Tao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fangbiao Tao', 'investigatorAffiliation': 'Anhui Medical University'}}}}