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

Anxiety Clinical Trial

— PM+FM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05627206
• Other study ID #: PM+FMZam
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2024
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Psychological Trauma
• Trauma, Psychological

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.

Locations

Country	Name	City	State
Zambia	Innovatations for Poverty Action	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Innovations for Poverty Action

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility of the study	% of 1 or more sessions completed. Qualitative feedback from participants and providers.	Assessed 4 months after enrollment
Primary	Acceptability	% of participants completing more than 6 sessions. Qualitative feedback from participants and providers.	Assessed 4 months after enrollment
Secondary	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
Secondary	Functionality	WHO-DAS2	Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
Secondary	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
Secondary	Change in Anxiety and Depression symptoms.	HSCL-25. 10 questions anxiety, 15 depression; (a = 0.90).	Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment