Back to results

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

Primary Purpose

Depressive Symptoms, Anxiety, Trauma, Psychological

Status

Active

Phase

Not Applicable

Locations

Zambia

Study Type

Interventional

Intervention

Problem Management + For Moms

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring women, low-resourced settings, psychosocial intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Innovatations for Poverty Action

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in Mental health symptoms. SRQ-20

20 items measuring risk of common mental health problem.

Feasibility of the study

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

Acceptability

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

Secondary Outcome Measures

Change in Mental health symptoms. PSYCHLOPS

Psychological Outcome Profiles (5 items)

Functionality

WHO-DAS2

World Bank's Toolkit and Inventory

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

Change in Anxiety and Depression symptoms.

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

Full Information

NCT ID

NCT05627206

First Posted

November 7, 2022

Last Updated

August 28, 2023

Sponsor

Swiss Tropical & Public Health Institute

Collaborators

Innovations for Poverty Action

1. Study Identification

Unique Protocol Identification Number

NCT05627206

Brief Title

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

Acronym

PM+FM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 15, 2022 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Swiss Tropical & Public Health Institute

Collaborators

Innovations for Poverty Action

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Symptoms, Anxiety, Trauma, Psychological

Keywords

women, low-resourced settings, psychosocial intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

270 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual care

Arm Type

No Intervention

Arm Title

Intervention

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Problem Management + For Moms

Intervention Description

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 Outcome Measure Information:

Title

Change in Mental health symptoms. SRQ-20

Description

20 items measuring risk of common mental health problem.

Time Frame

Change between Baseline (at enrollment) and 6 months after enrollment

Title

Feasibility of the study

Description

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

Time Frame

Assessed 4 months after enrollment

Title

Acceptability

Description

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

Time Frame

Assessed 4 months after enrollment

Secondary Outcome Measure Information:

Title

Change in Mental health symptoms. PSYCHLOPS

Description

Psychological Outcome Profiles (5 items)

Time Frame

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

Title

Functionality

Description

WHO-DAS2

Time Frame

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

Title

World Bank's Toolkit and Inventory

Description

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

Time Frame

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

Title

Change in Anxiety and Depression symptoms.

Description

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

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Innovatations for Poverty Action

City

Lusaka

Country

Zambia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs