The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
NCT ID: NCT05627206
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
270 participants
INTERVENTIONAL
2022-11-15
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited.
This 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preventing Mental Health Problems After Childhood Severe Malaria
NCT03432039
Family Intervention to Improve Maternal and Child Mental Health
NCT04700059
Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health
NCT03955718
Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention
NCT04481399
Trial of a Multi-pronged Intervention to Address Prevention of Violence in Zambia
NCT02790827
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Usual care
No interventions assigned to this group
Intervention
Problem Management + For Moms
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Problem Management + For Moms
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* SRQ-20 \>7 (clinically significant symptoms of depression or/anxiety),
* not planning to move within the next 6 months,
* with capacity to consent
* not receiving current mental health care.
Exclusion Criteria
* severe substance use (ACOK-SUD \>4),
* mania or psychotic symptoms
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Swiss Tropical & Public Health Institute
OTHER
Innovations for Poverty Action
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Irene Falgas Bague
Post-Doctoral Research Collaborator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Innovatations for Poverty Action
Lusaka, , Zambia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PM+FMZam
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.