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Study protocol for evaluating the effectiveness of depression management on gylcaemic control in non-communicable diseases clinics in Malawi
  1. Michael Mphatso Udedi1,2,3,
  2. Brian W Pence4,
  3. Felix Kauye1,3,
  4. Adamson S Muula3,5
  1. 1 Department of Mental Health, College of Medicine, University of Malawi, Blantyre, Malawi
  2. 2 Department of Clinical Services, Ministry of Health, Lilongwe, Malawi
  3. 3 Department of Public Health, School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi
  4. 4 Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  5. 5 Africa Center of Excellence in Public Health and Herbal Medicine, College of Medicine, University of Malawi, Blantyre, Malawi
  1. Correspondence to Michael Mphatso Udedi; mphatsoudedi{at}


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.

  • diabetes
  • depression
  • non communicable diseases
  • depression management
  • comorbidity

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  • Contributors MMU, BWP, FK and ASM were involved in the conceptualisation of the study. MMU was responsible for drafting the protocol manuscript. BWP, FK and ASM edited the protocol. All authors read and approved the final manuscript.

  • Funding This study protocol presents independent work supported through the DELTAS Africa Initiative (DEL-15-01). The DELTAS Africa Initiative is an independent funding scheme of the African Academy of Sciences' (AAS) Alliance for Accelerating Excellence in Science in Africa (AESA) and supported by the New Partnership for Africa’s Development Planning and Coordinating Agency (NEPAD Agency) with funding from the Wellcome Trust (DEL-15-01) and the UK government.

  • Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of AAS, NEPAD Agency, Wellcome Trust or the UK government.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval University of Malawi, College of Medicine Research and Ethics Committee (COMREC)

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The authors will share data of the original research article with their colleagues for academic purposes only. Currently the authors have not shared any unpublished data for the study.

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