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

NCT ID: NCT05627206

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-12-01

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.

Detailed Description

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Conditions

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Depressive Symptoms Anxiety Trauma, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Group Type EXPERIMENTAL

Problem Management + For Moms

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Innovations for Poverty Action

OTHER

Sponsor Role collaborator

Responsible Party

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Irene Falgas Bague

Post-Doctoral Research Collaborator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Innovatations for Poverty Action

Lusaka, , Zambia

Site Status

Countries

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Zambia

References

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Fink G, Melero-Dominguez M, Chembe M, de Vernisy-Romero D, Tembo T, Billima T, Paul R, Alegria M, Parkerson D, Rockers PC, Banda Z, Lungu G, Sikazwe D, Falgas-Bague I. Feasibility and acceptability of the Problem Management for Moms programme for improving maternal mental health in Zambia: an open-label trial. Lancet Psychiatry. 2024 Dec;11(12):965-974. doi: 10.1016/S2215-0366(24)00256-6. Epub 2024 Nov 5.

Reference Type DERIVED
PMID: 39515361 (View on PubMed)

Falgas-Bague I, Melero-Dominguez M, de Vernisy-Romero D, Tembo T, Chembe M, Lubozha T, Paul R, Parkerson D, Rockers PC, Sikazwe D, Fink G. Testing the feasibility, acceptability, and exploring trends on efficacy of the problem management plus for moms: Protocol of a pilot randomized control trial. PLoS One. 2024 Jan 5;19(1):e0287269. doi: 10.1371/journal.pone.0287269. eCollection 2024.

Reference Type DERIVED
PMID: 38181004 (View on PubMed)

Other Identifiers

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PM+FMZam

Identifier Type: -

Identifier Source: org_study_id

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