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Clinical Trials/NCT05627206
NCT05627206
Completed
Not Applicable

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

Swiss Tropical & Public Health Institute1 site in 1 country270 target enrollmentNovember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
Swiss Tropical & Public Health Institute
Enrollment
270
Locations
1
Primary Endpoint
Change in Mental health symptoms. SRQ-20
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Irene Falgas Bague

Post-Doctoral Research Collaborator

Swiss Tropical & Public Health Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Mental health symptoms. SRQ-20

Time Frame: Change between Baseline (at enrollment) and 6 months after enrollment

20 items measuring risk of common mental health problem.

Feasibility of the study

Time Frame: Assessed 4 months after enrollment

% of 1 or more sessions completed. Qualitative feedback from participants and providers.

Acceptability

Time Frame: Assessed 4 months after enrollment

% of participants completing more than 6 sessions. Qualitative feedback from participants and providers.

Secondary Outcomes

  • Functionality(Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment)
  • Change in Anxiety and Depression symptoms.(Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment)
  • World Bank's Toolkit and Inventory(Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment)
  • Change in Mental health symptoms. PSYCHLOPS(Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment)

Study Sites (1)

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