The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)

Not Applicable

Completed

• Conditions: Trauma, Psychological; Depressive Symptoms; Anxiety
• Interventions: Behavioral: Problem Management + For Moms

• Registration Number: NCT05627206
• Lead Sponsor: Swiss Tropical & Public Health Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-07
• Study Start: 2022-11-15
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-11-25
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Problem Management + For Moms	-

Primary Outcome Measures

Name	Time	Method
Change in Mental health symptoms. SRQ-20	Change between Baseline (at enrollment) and 6 months after enrollment	20 items measuring risk of common mental health problem.
Feasibility of the study	Assessed 4 months after enrollment	% of 1 or more sessions completed. Qualitative feedback from participants and providers.
Acceptability	Assessed 4 months after enrollment	% of participants completing more than 6 sessions. Qualitative feedback from participants and providers.

Secondary Outcome Measures

Name	Time	Method
Functionality	Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment	WHO-DAS2
Change in Anxiety and Depression symptoms.	Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment	HSCL-25. 10 questions anxiety, 15 depression; (α = 0.90).
World Bank's Toolkit and Inventory	Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment	Selected measures from the World Bank Toolkit to address mother-child interactions and child early development.
Change in Mental health symptoms. PSYCHLOPS	Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment	Psychological Outcome Profiles (5 items)

Trial Locations

Locations (1)

Innovatations for Poverty Action; 🇿🇲 Lusaka, Zambia