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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05627206
Acronym
PM+FM
Enrollment
270
Registered
2022-11-25
Start date
2022-11-15
Completion date
2023-12-01
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depressive Symptoms, Trauma, Psychological

Keywords

women, low-resourced settings, psychosocial intervention

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.

Interventions

BEHAVIORALProblem 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.

Sponsors

Innovations for Poverty Action
CollaboratorOTHER
Swiss Tropical & Public Health Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Mental health symptoms. SRQ-20Change between Baseline (at enrollment) and 6 months after enrollment20 items measuring risk of common mental health problem.
Feasibility of the studyAssessed 4 months after enrollment% of 1 or more sessions completed. Qualitative feedback from participants and providers.
AcceptabilityAssessed 4 months after enrollment% of participants completing more than 6 sessions. Qualitative feedback from participants and providers.

Secondary

MeasureTime frameDescription
Change in Mental health symptoms. PSYCHLOPSUsed for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollmentPsychological Outcome Profiles (5 items)
FunctionalityUsed for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollmentWHO-DAS2
World Bank's Toolkit and InventoryUsed for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollmentSelected measures from the World Bank Toolkit to address mother-child interactions and child early development.
Change in Anxiety and Depression symptoms.Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollmentHSCL-25. 10 questions anxiety, 15 depression; (α = 0.90).

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026