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OpenTrials
Completed

NCT Number: NCT05627206

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

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Key information

Conditions

Depressive Symptoms Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Psychological Trauma Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Psychological

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Innovatations for Poverty Action

Lusaka, Zambia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem Management + For Moms

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.

Primary outcomes

  1. 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.

  2. Feasibility of the study

    Time frame: Assessed 4 months after enrollment

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

  3. Acceptability

    Time frame: Assessed 4 months after enrollment

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

Secondary outcomes

  1. Change in Mental health symptoms. PSYCHLOPS

    Time frame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment

    Psychological Outcome Profiles (5 items)

  2. Functionality

    Time frame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment

    WHO-DAS2

  3. World Bank's Toolkit and Inventory

    Time frame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment

    Selected measures from the World Bank Toolkit to address mother-child interactions and child early development.

  4. Change in Anxiety and Depression symptoms.

    Time frame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment

    HSCL-25. 10 questions anxiety, 15 depression; (α = 0.90).

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Innovations for Poverty Action

Registry information

Acronym: PM+FM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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