Anxiety Clinical Trial
— PM+FMOfficial title:
The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
Verified date | April 2024 |
Source | Swiss Tropical & Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing. 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.
Status | Completed |
Enrollment | 270 |
Est. completion date | December 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women participating in ZamCharts parent study - 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: - Women with active suicidal ideation (determined by Paykel=4 OR 5), - severe substance use (ACOK-SUD >4), - mania or psychotic symptoms |
Country | Name | City | State |
---|---|---|---|
Zambia | Innovatations for Poverty Action | Lusaka |
Lead Sponsor | Collaborator |
---|---|
Swiss Tropical & Public Health Institute | Innovations for Poverty Action |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mental health symptoms. SRQ-20 | 20 items measuring risk of common mental health problem. | Change between Baseline (at enrollment) and 6 months after enrollment | |
Primary | Feasibility of the study | % of 1 or more sessions completed. Qualitative feedback from participants and providers. | Assessed 4 months after enrollment | |
Primary | Acceptability | % of participants completing more than 6 sessions. Qualitative feedback from participants and providers. | Assessed 4 months after enrollment | |
Secondary | Change in Mental health symptoms. PSYCHLOPS | Psychological Outcome Profiles (5 items) | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment | |
Secondary | Functionality | WHO-DAS2 | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment | |
Secondary | World Bank's Toolkit and Inventory | Selected measures from the World Bank Toolkit to address mother-child interactions and child early development. | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment | |
Secondary | Change in Anxiety and Depression symptoms. | HSCL-25. 10 questions anxiety, 15 depression; (a = 0.90). | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment |
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