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

Sponsor
Swiss Tropical & Public Health Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05627206
Collaborator
Innovations for Poverty Action (Other)
70
1
2
13
5.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Problem Management + For Moms
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual care

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Anxiety and Depression symptoms. [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).

  2. Change in Mental health symptoms. SRQ-20 [Change between Baseline (at enrollment) and 6 months after enrollment]

    20 items measuring risk of common mental health problem.

  3. Feasibility of the study [Assessed 4 months after enrollment]

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

  4. Acceptability [Assessed 4 months after enrollment]

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

Secondary Outcome Measures

  1. Change in Mental health symptoms. PSYCHLOPS [Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment]

    Psychological Outcome Profiles (5 items)

  2. Functionality [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women participating in ZamCharts parent study

  • SRQ-20 >7 (clinically significant symptoms of depression or/anxiety),

  • with 1 hour a week availability

  • 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 >3),

  • mania or psychotic symptoms

Contacts and Locations

Locations

Site City State Country Postal Code
1 Innovatations for Poverty Action Lusaka Zambia

Sponsors and Collaborators

  • Swiss Tropical & Public Health Institute
  • Innovations for Poverty Action

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Irene Falgas Bague, Post-Doctoral Research Collaborator, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT05627206
Other Study ID Numbers:
  • PM+FMZam
First Posted:
Nov 25, 2022
Last Update Posted:
Nov 25, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Irene Falgas Bague, Post-Doctoral Research Collaborator, Swiss Tropical & Public Health Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2022