Study protocol for evaluating the effectiveness of depression management on gylcaemic control in non-communicable diseases clinics in Malawi

INTRODUCTION: Depression is associated with negative patient outcomes for chronic diseases and likely affects consistent physical non-communicable diseases (NCDs) care management in relation to clinic attendance and medication adherence. We found no published studies on the integration of depression management in physical NCD clinics in Malawi and assessing its effects on patient and service outcomes. Therefore, the aim of this study is to evaluate the effectiveness of integrating depression screening and management in physical NCD routine care on patient and service outcomes in Malawi. We will also determine the sensitivity and specificity of the Patient Health Questionnaire-9 (PHQ-9) in the detection of depression in NCD clinics. METHODS AND ANALYSIS: The study will have two phases. Phase I will involve the validation of the PHQ-9 screening tool for depression, using a cross-sectional study design involving 323 participants, in two specialised physical NCD clinics in one of the 28 districts of Malawi. Using a quasi-experimental study design in four districts of Malawi not involved in the phase I study, the phase II study will evaluate the effectiveness of integrating depression screening (using PHQ-9) and management (based on a specially designed toolkit). Outcomes will be measured at 3 months and 6 months among patients with comorbid diabetes (poorly controlled) and depression attending physical NCD clinics in Malawi. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Malawi, College of Medicine Research and Ethics Committee (COMREC) on 31 August 2017 (reference P.07/17/2218). The findings will be disseminated through presentations at journal clubs, senior management of the Ministry of Health, national and international conferences as well as submission to peer-reviewed publications. Policy briefs will also be created. TRIAL REGISTRATION NUMBER: PACTR201807135104799.