Testing the Feasibility , Acceptability and Effectiveness of the Problem Management Plus for Moms: Protocol of a Randomized Control Trial.

Abstract

Background: Mental health disorders are one of the most common causes that limit the ability of mothers to care for themselves and their children. Recent data suggest high rates of distress among women in charge of young children in Zambia. Nevertheless, Zambia's public healthcare offers very limited treatment for common mental health distress. To address this treatment gap, this study aims to test the feasibility, acceptability, and potential efficacy of a context-adapted psychosocial intervention. Methods: A total of 270 mothers with mental health needs (defined as SRQ-20 scores above 7) will be randomly assigned with equal probability to the intervention or control group. The intervention group will receive a locally adapted version of the Problem-Management Plus and “Thinking positively” interventions developed by the World Health Organization (WHO) combined with specific parts of the Strong Minds-Strong Communities intervention. Trained and closely supervised wellbeing-community health workers will provide the psychosocial intervention. Mental health distress and attendance to the intervention will be assessed at enrollment and 6 months after the intervention. We will estimate the impact of the intervention on mental health distress using an intention-to-treat approach. Discussion: We previously found that there is a large necessity for interventions that aim to address mother anxiety/depression problems. In this study, we will test the feasibility and efficacy of an innovative intervention, demonstrating that implementing these mental health treatments in low-income settings, such as Zambia, is viable with an adequate support system. If successful, larger studies will be needed to test the effectiveness of the intervention with increased precision.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

Registry: clinical trials.org Trial Number: NCT05627206. URL: https://www.clinicaltrials.gov/ct2/show/NCT05627206

Clinical Protocols

https://www.clinicaltrials.gov/ct2/show/NCT05627206

Funding Statement

The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics approval was obtained by the ethical committee of the University of Zambia

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Deidentified research data will be made publicly available when the study is completed and published.

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