Feasibility of conducting a pilot randomized control trial of a psycho-education intervention in patients with a first episode psychosis in Uganda-A study protocol.

BACKGROUND: Psychotic disorders contribute to significant morbidity and mortality partly due to the chronicity of the illness and high relapse rates. Delivering psycho-education messages about disease etiology, their signs and symptoms and the benefits of treatment adherence have been shown to improve clinical outcomes among individuals with psychoses. However, little has been done to examine the feasibility and efficacy of this intervention in low resourced settings. OBJECTIVE: Our primary objective will be to determine the feasibility of recruiting and retaining patients with a first episode psychosis (FEP) and for the secondary objective, we will determine the preliminary efficacy of psycho-education on illness self-management, stigma, adherence to medications and symptom severity. HYPOTHESIS: We hypothesize that (i) we will recruit 70% of eligible participants and accrue a sample size of 80 over 20-weeks, retaining 80% of the sample size for 24 weeks, (ii) the intervention will lead to improvement in clinical outcomes (described above). METHODS: We will recruit 80 adult patients who have been diagnosed with a FEP, received antipsychotic medication at Butabika Hospital and reside within 21km from the Hospital. Trained village health team (VHTs) members will deliver 6 psycho-education sessions to 40 participants and their family members (intervention arm). Participants in the control arm (n = 40) will receive routine care. We will document how feasible it will be to recruit and retain participants over 24 weeks and document the preliminary efficacy of the intervention on illness self-management, stigma, adherence to medications and severity of symptoms. DATA ANALYSIS: We will document the proportion of participants who consent and get recruited, the proportion of those who will get retained and reasons for drop out. We will conduct an intention to treat analysis comparing the groups at weeks 4, 12, 24 and assess the effect of the intervention on the clinical outcomes (described above). We will use the Bonferroni approach to correct for multiple comparisons. TRIAL REGISTRATION: Clinical trials.gov registration number: NCT04602585.

Clinical outcomes among individuals with a first episode psychosis attending Butabika National Mental Referral Hospital in Uganda: a longitudinal cohort study. A study protocol for a longitudinal cohort study.

INTRODUCTION: Psychotic disorders significantly contribute to high morbidity and mortality. In high-income countries, the predictors of mortality, relapse and barriers to care among patients with first episode psychoses (FEP) have been studied as a means of tailoring interventions to improve patient outcomes. However, little has been done to document relapse rates and their predictors in patients with FEP in low resourced, high disease burdened sub-Saharan Africa. OBJECTIVE: We shall estimate the rates of relapse of psychotic symptoms and the factors that predict them in patients with FEP over 4 years. METHODS AND ANALYSIS: We will assemble a cohort of patients with an FEP seen at the Butabika National Mental Referral Hospital in Kampala over a 4-year period. Participants will be adults (≥18 years old), who have received a diagnosis of a psychosis according to the Mini International Neuropsychiatric Instrument (M.I.N.I.), with a demonstrable resolution of active symptoms following the use of antipsychotic medications, and deemed clinically stable for a discharge by the healthcare practitioner. All participants will be required to provide written informed consent. Trained research assistants will collect Demographic and clinical parameters, age of onset of symptoms, diagnostic data using the M.I.N.I., physical examination data, symptom severity, level of social and occupational functioning and household income, during the 4-year study period. We will conduct a verbal audit in the event of loss of life. We shall perform survival analysis using the Aalen-Johansen estimator, and describe the population characteristics by demographics, social and economic strata using simple proportions. ETHICS AND DISSEMINATION: All participants will provide written informed consent. Ethical approvals for the study have been obtained from the Makerere University School of Medicine Research and Ethics Committee and the Uganda National Council for Science and Technology. Findings will be published in peer reviewed journals.

The association between depression, quality of life, and the health care expenditure of patients with diabetes mellitus in Uganda.

BACKGROUND: Depression is one of the commonest neuropsychiatric disorders in patients with diabetes mellitus (DM) and is associated with poor glycaemic control, vascular complications, a low quality of life and increased health care expenditure. Co-morbid DM and depression remains poorly identified and inadequately treated in sub-Saharan Africa. METHODS: We conducted a cross-sectional survey of 437 patients with DM at 3 DM clinics in Uganda. Participants were assessed for depression, blood sugar levels, diabetic neuropathy, quality of life, and health care expenditures. RESULTS: The prevalence of depression was 34.8%. Depressed participants were more likely to be suicidal [OR=3.81, (CI 2.87-5.04)], younger [OR=3.98 CI (1.20-13.23)], un-employed [OR=1.99(CI 1.04-3.81)], and having lost a spouse [OR=2.36 (CI 1.29-4.31)]. Overall quality of life was poor [OR=0.67 (CI 0.47-0.96)], they scored poorer in the physical [OR=0.97, (CI 0.95-0.99)], psychological [OR=1.05 (CI 1.03-1.07)], and environmental [OR=0.97, (CI 0.95-0.99)] domains. They had an increased likelihood of incurring direct out-of-pocket payments for health care services [OR=1.56 (CI 1.03-2.36)], and were more likely to be impoverished [OR=1.52 (CI 1.01-2.28)]. LIMITATION: The cross sectional nature of this study makes it difficult to examine causation. More studies are required in order to better understand the associations and impact of the factors examined above on patient outcomes. CONCLUSIONS: Depression is highly prevalent among patients with DM in Uganda, and is associated with a number of adverse outcomes. A holistic approach that focuses on the depression management among patients with diabetes is recommended.