Efficacy and cost-effectiveness of task-shared care for people with severe mental disorders in Ethiopia (TaSCS): a single-blind, randomised, controlled, phase 3 non-inferiority trial.

BACKGROUND: There have been no trials of task-shared care (TSC) using WHO's mental health Gap Action Programme for people with severe mental disorders (psychosis or affective disorder) in low-income or middle-income countries. We aimed to evaluate the efficacy and cost-effectiveness of TSC compared with enhanced specialist mental health care in rural Ethiopia. METHODS: In this single-blind, phase 3, randomised, controlled, non-inferiority trial, participants had a confirmed diagnosis of a severe mental disorder, recruited from either the community or a local outpatient psychiatric clinic. The intervention was TSC, delivered by supervised, non-physician primary health care workers trained in the mental health Gap Action Programme and working with community health workers. The active comparison group was outpatient psychiatric nurse care augmented with community lay workers (PSY). Our primary endpoint was whether TSC would be non-inferior to PSY at 12 months for the primary outcome of clinical symptom severity using the Brief Psychiatric Rating Scale, Expanded version (BPRS-E; non-inferiority margin of 6 points). Randomisation was stratified by health facility using random permuted blocks. Independent clinicians allocated groups using sealed envelopes with concealment and outcome assessors and investigators were masked. We analysed the primary outcome in the modified intention-to-treat group and safety in the per-protocol group. This trial is registered with ClinicalTrials.gov, number NCT02308956. FINDINGS: We recruited participants between March 13, 2015 and May 21, 2016. We randomly assigned 329 participants (111 female and 218 male) who were aged 25-72 years and were predominantly of Gurage (198 [60%]), Silte (58 [18%]), and Mareko (53 [16%]) ethnicity. Five participants were found to be ineligible after randomisation, giving a modified intention-to-treat sample of 324. Of these, 12-month assessments were completed in 155 (98%) of 158 in the TSC group and in 158 (95%) of 166 in the PSY group. For the primary outcome, there was no evidence of inferiority of TSC compared with PSY. The mean BPRS-E score was 27·7 (SD 4·7) for TSC and 27·8 (SD 4·6) for PSY, with an adjusted mean difference of 0·06 (90% CI -0·80 to 0·89). Per-protocol analyses (n=291) were similar. There were 47 serious adverse events (18 in the TSC group, 29 in the PSY group), affecting 28 participants. These included 17 episodes of perpetrated violence and seven episodes of violent victimisation leading to injury, ten suicide attempts, six hospital admissions for physical health conditions, four psychiatric admissions, and three deaths (one in the TSC group, two in the PSY group). The incremental cost-effectiveness ratio for TSC indicated lower cost of -US$299·82 (95% CI -454·95 to -144·69) per unit increase in BPRS-E scores from a health care sector perspective at 12 months. INTERPRETATION: WHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings. FUNDING: US National Institute of Mental Health.

Development of a scalable mental healthcare plan for a rural district in Ethiopia.

BACKGROUND: Developing evidence for the implementation and scaling up of mental healthcare in low- and middle-income countries (LMIC) like Ethiopia is an urgent priority. AIMS: To outline a mental healthcare plan (MHCP), as a scalable template for the implementation of mental healthcare in rural Ethiopia. METHOD: A mixed methods approach was used to develop the MHCP for the three levels of the district health system (community, health facility and healthcare organisation). RESULTS: The community packages were community case detection, community reintegration and community inclusion. The facility packages included capacity building, decision support and staff well-being. Organisational packages were programme management, supervision and sustainability. CONCLUSIONS: The MHCP focused on improving demand and access at the community level, inclusive care at the facility level and sustainability at the organisation level. The MHCP represented an essential framework for the provision of integrated care and may be a useful template for similar LMIC.

Burden of mental disorders and unmet needs among street homeless people in Addis Ababa, Ethiopia.

BACKGROUND: The impact of mental disorders among homeless people is likely to be substantial in low income countries because of underdeveloped social welfare and health systems. As a first step towards advocacy and provision of care, we conducted a study to determine the burden of psychotic disorders and associated unmet needs, as well as the prevalence of mental distress, suicidality, and alcohol use disorder among homeless people in Addis Ababa, the capital of Ethiopia. METHODS: A cross-sectional survey was conducted among street homeless adults. Trained community nurses screened for potential psychosis and administered standardized measures of mental distress, alcohol use disorder and suicidality. Psychiatric nurses then carried out confirmatory diagnostic interviews of psychosis and administered a locally adapted version of the Camberwell Assessment of Needs Short Appraisal Schedule. RESULTS: We assessed 217 street homeless adults, about 90% of whom had experienced some form of mental or alcohol use disorder: 41.0% had psychosis, 60.0% had hazardous or dependent alcohol use, and 14.8% reported attempting suicide in the previous month. Homeless people with psychosis had extensive unmet needs with 80% to 100% reporting unmet needs across 26 domains. Nearly 30% had physical disability (visual and sensory impairment and impaired mobility). Only 10.0% of those with psychosis had ever received treatment for their illness. Most had lived on the streets for over 2 years, and alcohol use disorder was positively associated with chronicity of homelessness. CONCLUSION: Psychoses and other mental and behavioural disorders affect most people who are street homeless in Addis Ababa. Any programme to improve the condition of homeless people should include treatment for mental and alcohol use disorders. The findings have significant implications for advocacy and intervention programmes, particularly in similar low income settings.

Validity of the Patient Health Questionnaire-9 for depression screening and diagnosis in East Africa.

Depression is often underdiagnosed and undertreated in primary care settings, particularly in developing countries. This is, in part, due to challenges resulting from lack of skilled mental health workers, stigma associated with mental illness, and lack of cross-culturally validated screening instruments. We conducted this study to evaluate the reliability and validity of the Patient Health Questionnaire-9 (PHQ-9) as a screen for diagnosing major depressive disorder among adults in Ethiopia, the second most populous country in sub-Saharan Africa. A total of 926 adults attending outpatient departments in a major referral hospital in Ethiopia participated in this study. We assessed criterion validity and performance characteristics against an independent, blinded, and psychiatrist administered semi-structured Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview. Overall, the PHQ-9 items showed good internal (Cronbach's alpha=0.81) and test re-test reliability (intraclass correlation coefficient=0.92). A factor analysis confirmed a one-factor structure. Receiver Operating Characteristics (ROC) analysis showed that a PHQ-9 threshold score of 10 offered optimal discriminatory power with respect to diagnosis of major depressive disorder via the clinical interview (sensitivity=86% and specificity=67%). The PHQ-9 appears to be a reliable and valid instrument that may be used to diagnose major depressive disorders among Ethiopian adults.

Predictors of carer-burden in schizophrenia: a five-year follow-up study in Butajira, Ethiopia.

OBJECTIVE: We assessed carer-burden and its predictors in a traditional rural Ethiopian community in order to establish the longitudinal course of carer-burden and factors predicting changes. METHODS: Using a 5-year follow-up data from the ongoing Butajira outcome study on SMI, carer-burden was assessed annually with the Family Interview Schedule (FIS). Multilevel modeling was used to identify clinical predictors of severity and rate of change of burden. RESULTS: Scores in all domains of carer burden decreased over time, although the greatest reduction was seen in the first year. In a univariate analyses, longitudinal reduction in burden score was predicted by longer period in remission during follow-up, while negative and positive symptom severity scores predicted higher burden score. In the fully adjusted model, poor social support predicted higher burden score (beta=0.38, 95%CI 0.04, 0.72), and longer period in remission predicted lower level of carer-burden (beta = -0.49, 95%CI = -0.89, - 0.10). Reduction in positive symptoms was associated with the instantaneous rate of reduction of burden score (beta = -0.03, 95%CI - 0.05, -0.01). CONCLUSION: There is a significant reduction in carer-burden over the years in all burden domains. Providing accessible mental health care has the potential to alleviate carer-burden, as positive symptoms are believed to be more amenable to intervention. The study also indicates that remission is associated with reduction in carer-burden.

Internalized stigma among patients with schizophrenia in Ethiopia: a cross-sectional facility-based study.

BACKGROUND: Despite the potential impact on treatment adherence and recovery, there is a dearth of data on the extent and correlates of internalized stigma in patients with schizophrenia in low income countries. We conducted a study to determine the extent, domains and correlates of internalized stigma amongst outpatients with schizophrenia in Ethiopia. METHODS: The study was a cross-sectional facility-based survey conducted at a specialist psychiatric hospital in Addis Ababa, Ethiopia. Consecutive consenting individuals with a diagnosis of schizophrenia were recruited and assessed using an Amharic version of the Internalized Stigma of Mental Illness (ISMI) scale. RESULTS: Data were collected from 212 individuals, who were mostly single (71.2%), unemployed (70.3%) and male (65.1%). Nearly all participants (97.4%) expressed agreement to at least one stigma item contained in the ISMI; 46.7% had a moderate to high mean stigma score. Rural residence (OR = 5.67; 95% CI = 2.30, 13.00; p < 0.001), single marital status (OR = 3.39; 95% CI = 1.40, 8.22; p = 0.019) and having prominent psychotic symptoms (OR = 2.33; 95% CI = 1.17, 4.61; p = 0.016) were associated independently with a higher stigma score. Almost half of those who discontinued their treatment reported that they had done so because of perceived stigma. Those who had attempted suicide (45.3%) were more likely to have a high stigma score (OR = 2.29; 95% CI = 1.27, 4.11; p = 0.006). Over 60% of the variation in the experience of stigma was explained by four factors: social withdrawal (16.7%), perceived discrimination (14.1%), alienation (13.9%) and stereotype endorsement (12.7%). CONCLUSION: Internalized stigma is a major problem among persons with schizophrenia in this outpatient setting in Ethiopia. Internalized stigma has the potential to substantially affect adherence to medication and is likely to affect the recovery process.

Health related quality of life (SF-36) survey in Butajira, rural Ethiopia: normative data and evaluation of reliability and validity.

UNLABELLED: The SF-36 health survey, a generic measure of health related quality of life (HRQOL), has been translated, evaluated in various languages and used in over 40 countries worldwide, although it has not been used in Ethiopia. OBJECTIVE: To measure the reliability and validity of the SF-36, to establish general population norms for various sex and age groups, to describe the effects of socio-demographic factors on SF-36 scores, and SF-36 scores in patients with major mental disorders. METHODS: Following the standard procedures of forward and back translation and adaptation, an Amharic SF-36 was developed This was subsequently used in a health survey of a general rural population of 1.990 in Butajira. The instrument was also used to interview a group of patients with schizophrenia, bipolar and depressive disorders. RESULTS: Mean scores of all of the eight domains of the SF-36 general population of Butajira decreased (indicating poorer HRQOL) with increasing age in both males and females. The odds of being in the lowest quartile of the PCS were 3.6 times higher in those aged 40-49 years when compared to those younger than 20 years Adjusted Odds Ratio (95% CI) = 3.62 (2.32, 5.66). In both males and females, the SF-36 scores for the eight domains and the two summary scales were significantly lower among all the three cases of major mental disorders compared to the general population. CONCLUSION: The SF-36 appears to be an appropriate measure for measuring health related quality of life in various population groups in Ethiopia.