التفاصيل البيبلوغرافية
| العنوان: |
Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial. |
| المؤلفون: |
McBain, Ryan K., Mwale, Owen, Ruderman, Todd, Kayira, Waste, Connolly, Emilia, Chalamanda, Mark, Kachimanga, Chiyembekezo, Khongo, Brown David, Wilson, Jesse, Wroe, Emily, Raviola, Giuseppe, Smith, Stephanie, Coleman, Sarah, Kelly, Ksakrad, Houde, Amruta, Tebeka, Mahlet G., Watson, Samuel, Kulisewa, Kazione, Udedi, Michael, Wagner, Glenn |
| المصدر: |
Trials; 9/16/2021, Vol. 22 Issue 1, p1-14, 14p, 3 Diagrams, 2 Charts |
| مصطلحات موضوعية: |
CLUSTER randomized controlled trials, SYSTOLIC blood pressure, MENTAL depression, RESEARCH protocols, INTEGRATIVE medicine, HEALTH facilities, VIRAL load |
| مصطلحات جغرافية: |
MALAWI, SUB-Saharan Africa |
| مستخلص: |
Background: Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes.Methods: We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model.Discussion: This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.Trial Registration: ClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021. [ABSTRACT FROM AUTHOR] |
|
Copyright of Trials is the property of BioMed Central and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
Find this article in full text from Springer Verlag. 
Full Text Finder