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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms; Trauma, Psychological
• Intervention / Treatment: Behavioral: Problem Management + For Moms

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • Innovatations for Poverty Action

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Problem 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.
No Intervention: Usual care

What is the study measuring?

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 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
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

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Innovations for Poverty Action

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: psychosocial intervention; women; low-resourced settings
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Depression; Psychological Trauma
• Other Study ID Numbers: PM+FMZam

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No