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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depressive Symptoms, Anxiety, Trauma, Psychological

Intervention / Treatment
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* Behavioral: Problem Management + For Moms


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br> | |
| Experimental: Intervention<br> | Behavioral: Problem Management + For Moms<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Feasibility of the study | % of 1 or more sessions completed. Qualitative feedback from participants and providers. | Assessed 4 months after enrollment | 
| Acceptability | % of participants completing more than 6 sessions. Qualitative feedback from participants and providers. | Assessed 4 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Functionality | WHO-DAS2 | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment | 
| 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 | 
| Change in Anxiety and Depression symptoms. | HSCL-25. 10 questions anxiety, 15 depression; (α = 0.90). | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women, low-resourced settings, psychosocial intervention