Ignite Creation Date:
2025-12-26 @ 1:15 PM
Ignite Modification Date:
2025-12-26 @ 1:15 PM
Study NCT ID:
NCT01172106
Status:
UNKNOWN
Last Update Posted:
2010-07-29
First Post:
2010-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Family Psychoeducation on Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-28', 'studyFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2010-07-28', 'lastUpdatePostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perceived social support of mothers', 'timeFrame': '3 months', 'description': '12 weekly sessions of family psychoeducation for a period of 3 months will improve perceived social support of mothers in the intervention arm.'}], 'secondaryOutcomes': [{'measure': 'Improvement of psychological distress of the caregivers', 'timeFrame': '3 months', 'description': '12 weekly sessions of family psychoeducation with caregivers for a period of 3 months will improve psychological distress in caregivers of mothers that will have received family psychoeducation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postpartum psychosis', 'Perceived social support', 'Family psychoeducation'], 'conditions': ['Postpartum Psychosis']}, 'descriptionModule': {'briefSummary': 'There is currently no clear involvement of families/caregivers in the care for postpartum mothers that develop postpartum psychosis. The lack of knowledge on causes of postpartum psychosis may influence the nature of perceived social support that mothers receive from caregivers. It is hoped that the provision of a culturally adapted version of family psychoeducation will bridge the knowledge gap and provide the much needed information. We therefore hypothesized that the involvement of a family member of a postpartum mother with a psychotic illness in a weekly session of family psychoeducation.', 'detailedDescription': "Postpartum psychosis causes distress to the mother, baby, spouse and other primary caregivers. This is especially true for Uganda where cultural beliefs for the causation of the illness place blame on supposedly the postpartum mother's promiscuity during pregnancy (COX, 1979). Cultural perceptions on the causes of postpartum psychosis may affect the nature of social support the mothers perceive from their families when they develop the illness. Other perceptions regarding postpartum psychosis in Uganda lay blame on supernatural causes like witchcraft.\n\nFamily psychoeducation which sets out to inform families of the nature of the illness is called for so as to demystify the illness."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postpartum mothers with a psychiatric illness in the current postpartum period.\n* Must have been admitted to the mental health facility for the current episode.\n\nExclusion Criteria:\n\n* Mothers residing out of a radius of 50 km away from the health facility.\n* Mothers that do not have caregivers.\n* Mothers who are not fluent in the language in which the study will be conducted.'}, 'identificationModule': {'nctId': 'NCT01172106', 'briefTitle': 'Impact of Family Psychoeducation on Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'The Role of Psychoeducation on Perceived Social Support of Postpartum Others With a Psychotic Illness', 'orgStudyIdInfo': {'id': '2006/HD11/4572U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Encouragement on drug compliance', 'description': 'The intervention for the placebo comparator will be encouragement on drug compliance', 'interventionNames': ['Behavioral: drug compliance', 'Behavioral: Encouragement of drug compliance']}, {'type': 'EXPERIMENTAL', 'label': 'Family psychoeducation', 'description': 'The experimental group will receive weekly sessions of psychoeducation for 12 weeks in addition to receiving drug compliance encouragement', 'interventionNames': ['Behavioral: Family psychoeducation']}], 'interventions': [{'name': 'drug compliance', 'type': 'BEHAVIORAL', 'otherNames': ['Psychosocial intervention'], 'description': 'Mothers and their caregivers will be encouraged to comply with the given medication', 'armGroupLabels': ['Encouragement on drug compliance']}, {'name': 'Encouragement of drug compliance', 'type': 'BEHAVIORAL', 'otherNames': ['Psychosocial intervention'], 'description': 'Mothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement', 'armGroupLabels': ['Encouragement on drug compliance']}, {'name': 'Family psychoeducation', 'type': 'BEHAVIORAL', 'otherNames': ['Psychosocial intervention'], 'description': 'The experimental group will receive family psychoeducation for 12 sessions', 'armGroupLabels': ['Family psychoeducation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7072', 'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Janet Nakigudde', 'role': 'CONTACT', 'email': 'jnakigudde@hotmail.com', 'phone': '+256-772-407-885'}, {'name': 'Eija Airaksinen', 'role': 'CONTACT', 'email': 'eija.airaksinen@ki.se', 'phone': '+468737840'}, {'name': 'Janet Nakigudde', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Makerere University College of Health Sciences', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'zip': 'P.O.Box 7072', 'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Janet Nakigudde', 'role': 'CONTACT', 'email': 'jnakigudde@hotmail.com', 'phone': '+256-772-407-885'}, {'name': 'Eija Airksinen', 'role': 'CONTACT', 'email': 'eija.airaksinen@ki.se', 'phone': '+46-87373857'}, {'name': 'Janet Nakigudde', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Makerere University College of Health Sciences', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Janet Nakigudde', 'role': 'CONTACT', 'email': 'jnakigudde@hotmail.com', 'phone': '+256-772-407-885'}, {'name': 'Janet Nakigudde', 'role': 'CONTACT', 'email': 'jnakigudde@chs.mak.ac.ug', 'phone': '+256-772-407-885'}], 'overallOfficials': [{'name': 'Eija Airaksinen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish International Development Cooperation Agency (SIDA)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Janet Nakigudde', 'oldOrganization': 'Department of Psychiatry, College of Health Sciences, Makerere University'}}}}