Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-01-24 @ 4:24 AM
Study NCT ID:
NCT05627206
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000067073', 'term': 'Psychological Trauma'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-23', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mental health symptoms. SRQ-20', 'timeFrame': 'Change between Baseline (at enrollment) and 6 months after enrollment', 'description': '20 items measuring risk of common mental health problem.'}, {'measure': 'Feasibility of the study', 'timeFrame': 'Assessed 4 months after enrollment', 'description': '% of 1 or more sessions completed. Qualitative feedback from participants and providers.'}, {'measure': 'Acceptability', 'timeFrame': 'Assessed 4 months after enrollment', 'description': '% of participants completing more than 6 sessions. Qualitative feedback from participants and providers.'}], 'secondaryOutcomes': [{'measure': 'Change in Mental health symptoms. PSYCHLOPS', 'timeFrame': 'Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment', 'description': 'Psychological Outcome Profiles (5 items)'}, {'measure': 'Functionality', 'timeFrame': 'Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment', 'description': 'WHO-DAS2'}, {'measure': "World Bank's Toolkit and Inventory", 'timeFrame': 'Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment', 'description': 'Selected measures from the World Bank Toolkit to address mother-child interactions and child early development.'}, {'measure': 'Change in Anxiety and Depression symptoms.', 'timeFrame': 'Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment', 'description': 'HSCL-25. 10 questions anxiety, 15 depression; (α = 0.90).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['women', 'low-resourced settings', 'psychosocial intervention'], 'conditions': ['Depressive Symptoms', 'Anxiety', 'Trauma, Psychological']}, 'referencesModule': {'references': [{'pmid': '39515361', 'type': 'DERIVED', 'citation': 'Fink G, Melero-Dominguez M, Chembe M, de Vernisy-Romero D, Tembo T, Billima T, Paul R, Alegria M, Parkerson D, Rockers PC, Banda Z, Lungu G, Sikazwe D, Falgas-Bague I. Feasibility and acceptability of the Problem Management for Moms programme for improving maternal mental health in Zambia: an open-label trial. Lancet Psychiatry. 2024 Dec;11(12):965-974. doi: 10.1016/S2215-0366(24)00256-6. Epub 2024 Nov 5.'}, {'pmid': '38181004', 'type': 'DERIVED', 'citation': 'Falgas-Bague I, Melero-Dominguez M, de Vernisy-Romero D, Tembo T, Chembe M, Lubozha T, Paul R, Parkerson D, Rockers PC, Sikazwe D, Fink G. Testing the feasibility, acceptability, and exploring trends on efficacy of the problem management plus for moms: Protocol of a pilot randomized control trial. PLoS One. 2024 Jan 5;19(1):e0287269. doi: 10.1371/journal.pone.0287269. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': "CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing.\n\nDespite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited.\n\nThis study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women participating in ZamCharts parent study\n* SRQ-20 \\>7 (clinically significant symptoms of depression or/anxiety),\n* not planning to move within the next 6 months,\n* with capacity to consent\n* not receiving current mental health care.\n\nExclusion Criteria:\n\n* Women with active suicidal ideation (determined by Paykel=4 OR 5),\n* severe substance use (ACOK-SUD \\>4),\n* mania or psychotic symptoms'}, 'identificationModule': {'nctId': 'NCT05627206', 'acronym': 'PM+FM', 'briefTitle': "The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)", 'organization': {'class': 'OTHER', 'fullName': 'Swiss Tropical & Public Health Institute'}, 'officialTitle': "The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)", 'orgStudyIdInfo': {'id': 'PM+FMZam'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: Problem Management + For Moms']}], 'interventions': [{'name': 'Problem Management + For Moms', 'type': 'BEHAVIORAL', 'description': 'Psychosocial intervention conducted by a trained Wellbeing-Community health worker. Adapted from Problem Management +, thinking healthy and Strong Minds-Strong Communities intervention to target women with small children and mental health symptoms living in low-resourced settings. Combines several evidence-based strategies such us psychoeducational, motivational interviewing, cognitive restructuring and relaxation exercises. Organized in 10 weekly sessions (8 individual 2 in group) provided in-person, by phone or virtually.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Innovatations for Poverty Action', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Tropical & Public Health Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovations for Poverty Action', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-Doctoral Research Collaborator', 'investigatorFullName': 'Irene Falgas Bague', 'investigatorAffiliation': 'Swiss Tropical & Public Health Institute'}}}}