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

NCT05627206 | Completed

• 1 other identifier: PM+FMZam
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety; Trauma, Psychological

Keywords

women; low-resourced settings; psychosocial intervention

Outcome Measures

Primary Outcomes (3)

• 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

• Feasibility of the study

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

  Assessed 4 months after enrollment

• Acceptability

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

  Assessed 4 months after enrollment

Secondary Outcomes (4)

• Change in Mental health symptoms. PSYCHLOPS

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

• Functionality

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

• World Bank's Toolkit and Inventory

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

• Change in Anxiety and Depression symptoms.

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

Study Arms (2)

Usual care

NO INTERVENTION

Intervention

EXPERIMENTAL

Behavioral: Problem Management + For Moms

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women with active suicidal ideation (determined by Paykel=4 OR 5),
• severe substance use (ACOK-SUD \>4),
• mania or psychotic symptoms

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Innovations for Poverty Action: collaborator

Study Sites (1)

Innovatations for Poverty Action

Lusaka, Zambia

Location

Related Publications (2)

• 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.

  PMID: 39515361 DERIVED

• 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.

  PMID: 38181004 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Trauma

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Research Collaborator

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 25, 2022
• Study Start: November 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

ZA (1)