Studying the context of psychoses to improve outcomes in Ethiopia (SCOPE): Protocol paper.

BACKGROUND: Global evidence on psychosis is dominated by studies conducted in Western, high-income countries. The objectives of the Study of Context Of Psychoses to improve outcomes in Ethiopia (SCOPE) are (1) to generate rigorous evidence of psychosis experience, epidemiology and impacts in Ethiopia that will illuminate aetiological understanding and (2) inform development and testing of interventions for earlier identification and improved first contact care that are scalable, inclusive of difficult-to-reach populations and optimise recovery. METHODS: The setting is sub-cities of Addis Ababa and rural districts in south-central Ethiopia covering 1.1 million people and including rural, urban and homeless populations. SCOPE comprises (1) formative work to understand care pathways and community resources (resource mapping); examine family context and communication (ethnography); develop valid measures of family communication and personal recovery; and establish platforms for community engagement and involvement of people with lived experience; (2a) a population-based incidence study, (2b) a case-control study and (2c) a cohort study with 12 months follow-up involving 440 people with psychosis (390 rural/Addis Ababa; 50 who are homeless), 390 relatives and 390 controls. We will test hypotheses about incidence rates in rural vs. urban populations and men vs. women; potential aetiological role of khat (a commonly chewed plant with amphetamine-like properties) and traumatic exposures in psychosis; determine profiles of needs at first contact and predictors of outcome; (3) participatory workshops to develop programme theory and inform co-development of interventions, and (4) evaluation of the impact of early identification strategies on engagement with care (interrupted time series study). Findings will inform development of (5) a protocol for (5a) a feasibility cluster randomised controlled trial of interventions for people with recent-onset psychosis in rural settings and (5b) two uncontrolled pilot studies to test acceptability, feasibility of co-developed interventions in urban and homeless populations.

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.

Correction to: Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.

An amendment to this paper has been published and can be accessed via the original article.

The effect of gender on the long-term course and outcome of schizophrenia in rural Ethiopia: a population-based cohort.

BACKGROUND: Although some studies have suggested that women with schizophrenia are more likely to achieve positive outcomes, the evidence-base is fraught with inconsistencies. In this study we compare the long-term course and outcomes for men and women living with schizophrenia in rural Ethiopia. METHODS: The Butajira course and outcome study for severe mental disorders is a population-based cohort study. Community ascertainment of cases was undertaken between 1998 and 2001, with diagnostic confirmation by clinicians using the Schedules for Clinical Assessment in Neuropsychiatry. Findings from annual outcome assessments were combined with clinical records, patient and caregiver report, and psychiatric assessments at 10-13 years using the Longitudinal Interval Follow-up Evaluation- LIFE chart. For the sub-group of people with schizophrenia (n = 358), we compared course of illness and treatment, co-morbidity, recovery, social outcomes and mortality between men and women. Multivariable analyses were conducted for modelling associations identified in bivariate analyses according to blocks shaped by our a priori conceptual framework of the biological and social pathways through which gender might influence the course and outcome of schizophrenia. RESULTS: Looking into over 10-13 years of follow-up data, there was no difference in the functioning or recovery in women compared to men (AOR = 1.79, 95% CI = 0.91, 3.57). Women were less likely to report overall life satisfaction (AOR = 0.22, 95% CI = 0.09, 0.53) or good quality of spousal relationships (AOR = 0.09, 95% CI = 0.01-1.04). Men were more likely to have co-morbid substance use and there was a trend towards women being more likely to be prescribed an antidepressant (AOR = 2.38, 95% CI = 0.94, 5.88). There were no gender differences in the course of illness, number of psychotic episodes or adherence to medications. CONCLUSION: In this rural African setting, we found little evidence to support the global evidence indicating better course and outcome of schizophrenia in women. Our findings are suggestive of a gendered experience of schizophrenia which varies across contexts. Further investigation is needed due to the important implications for the development of new mental health services in low and middle-income country settings.

The psychosis treatment gap and its consequences in rural Ethiopia.

BACKGROUND: The "treatment gap" (TG) for mental disorders, widely advocated by the WHO in low-and middle-income countries, is an important indicator of the extent to which a health system fails to meet the care needs of people with mental disorder at the population level. While there is limited research on the TG in these countries, there is even a greater paucity of studies looking at TG beyond a unidimensional understanding. This study explores several dimensions of the TG construct for people with psychosis in Sodo, a rural district in Ethiopia, and its implications for building a more holistic capacity for mental health services. METHOD: The study was a cross-sectional survey of 300 adult participants with psychosis identified through community-based case detection and confirmed through subsequent structured clinical evaluations. The Butajira Treatment Gap Questionnaire (TGQ), a new customised tool with 83 items developed by the Ethiopia research team, was administered to evaluate several TG dimensions (access, adequacy and effectiveness of treatment, and impact/consequence of the treatment gap) across a range of provider types corresponding with the WHO pyramid service framework. RESULTS: Lifetime and current access gap for biomedical care were 41.8 and 59.9% respectively while the corresponding figures for faith and traditional healing (FTH) were 15.1 and 45.2%. Of those who had received biomedical care for their current episode, 71.7% did not receive minimally adequate care. Support from the community and non-governmental organisations (NGOs) were negligible. Those with education (Adj. OR: 2.1; 95% CI: 1.2, 3.8) and history of use of FTH (Adj. OR: 3.2; 95% CI: 1.9-5.4) were more likely to use biomedical care. Inadequate biomedical care was associated with increased lifetime risk of adverse experiences, such as history of restraint, homelessness, accidents and assaults. CONCLUSION: This is the first study of its kind. Viewing TG not as a unidimensional, but as a complex, multi-dimensional construct, offers a more realistic and holistic understanding of health beliefs, help-seeking behaviors, and need for care. The reconceptualized multidimensional TG construct could assist mental health services capacity building advocacy and policy efforts and allow community and NGOs play a larger role in supporting mental healthcare.

"He can send her to her parents": The interaction between marriageability, gender and serious mental illness in rural Ethiopia.

BACKGROUND: For women in most low- and middle-income countries, the diagnosis with serious mental illness (SMI) leads to stigma and challenges related to starting or maintaining marriages. The purpose of this qualitative study was to explore perspectives on marriage, divorce and family roles of women with SMI in rural Ethiopia. METHODS: A qualitative study was conducted in a rural setting of Butajira, South Central Ethiopia. A total of 39 in-depth interviews were carried out with service users (n = 11), caregivers (n = 12), religious leaders (n = 6), health extension workers (n = 4), police officers (n = 2), teachers (n = 2) and government officials (n = 2). Data were analyzed using a thematic approach. RESULTS: Three themes emerged. (1) Marriage and SMI: Chances of getting married for individuals with SMI in general was perceived to be lower: Individuals with SMI experienced various challenges including difficulty finding romantic partner, starting family and getting into a long-term relationship due to perceived dangerousness and the widespread stigma of mental illness. (2) Gendered experiences of marriageability: Compared to men, women with SMI experienced disproportionate levels of stigma which often continued after recovery. SMI affects marriageability for men with SMI, but mens' chances of finding a marital partner increases following treatment. For women in particular, impaired functioning negatively affects marriageability as ability to cook, care and clean was taken as the measure of suitability. (3) Acceptability of divorce and separation from a partner with SMI: Divorce or separation from a partner with SMI was considered mostly acceptable for men while women were mostly expected to stay married and care for a partner with SMI. For men, the transition from provider to dependent was often acceptable. However, women who fail to execute their domestic roles successfully were considered inept and would be sent back to their family of origin. CONCLUSION: Women with SMI or those married to partners with SMI are at greater disadvantage. Reducing vulnerabilities through stigma reduction efforts such as community outreach and mental health awareness raising programs might contribute for better social outcomes for women with SMI.

Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.

BACKGROUND: Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country. METHODS/DESIGN: A randomised, controlled, non-inferiority trial will be carried out in a predominantly rural area of Ethiopia. A sample of 324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic. The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months. Participants in the active control arm will receive the established and effective model of specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital. The hypothesis is that people with SMD who receive mental health care integrated into PHC will have a non-inferior clinical outcome, defined as a mean symptom score on the Brief Psychiatric Rating Scale, expanded version, of no more than six points higher, compared to participants who receive the psychiatric nurse-led service, after 12 months. The primary outcome is change in symptom severity. Secondary outcomes are functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness. Sustainability and cost-effectiveness will be further evaluated at 18 months. Randomisation will be stratified by health centre catchment area using random permuted blocks. The outcome assessors and investigators will be masked to allocation status. DISCUSSION: Evidence about the effectiveness of task sharing mental health care for people with SMD in a rural, low-income African country will inform the World Health Organisation's mental health Gap Action Programme to scale-up mental health care globally. TRIAL REGISTRATION: NCT02308956 (ClinicalTrials.gov). Date of registration: 3 December 2014.

Participatory planning of a primary care service for people with severe mental disorders in rural Ethiopia.

Little is understood about the feasibility and acceptability of primary care-based models of task-sharing care for people with severe mental disorders (SMDs) in low- and middle-income countries (LMICs). A participatory planning approach was adopted in preparation for the transition from hospital-delivered psychiatric care for SMD to a primary care-based, task-sharing model in a rural Ethiopian community. In this article, we present findings from community consultation meetings (n = 4), focus group discussions (n = 7) and in-depth interviews (n = 11) with key stakeholders (healthcare administrators and providers, caregivers, service-users and community leaders) which were carried out over a 2-year period in the context of ongoing dialogue with the community. The principle of local delivery of mental health services was agreed upon by all stakeholder groups. Key reasons for supporting local delivery were increased access for the majority due to proximity, reduced cost and reduced stress related to transportation. However, acceptance of the new service was qualified by concerns about the competence of staff to deliver a comprehensive and dependable service of equal quality to that currently provided at the hospital. Adequate training and support, as well as ensuring consistency of medication supply were identified as key components to ensure success. Encouragingly, our results suggest that there is significant support for the service change and an interest for the mobilization of community resources to support this. One of the study strengths was that we were able to present the different perspectives of multiple stakeholder groups. By nesting the study in an ongoing community-based cohort of people with SMD we were able to interview a more representative and empowered group of caregivers and service users than is often available in LMICs. Despite this, the extent to which service-users are able to express their opinions is likely limited by their marginalized role in rural Ethiopian society.

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.

Excess mortality in severe mental illness: 10-year population-based cohort study in rural Ethiopia.

BACKGROUND: Evidence on mortality in severe mental illness (SMI) comes primarily from clinical samples in high-income countries. AIMS: To describe mortality in people with SMI among a population cohort from a low-income country. METHOD: We followed-up 919 adults (from 68 378 screened) with SMI over 10 years. Standardised mortality ratios (SMR) and years of life lost (YLL) as a result of premature mortality were calculated. RESULTS: In total 121 patients (13.2%) died. The overall SMR was twice that of the general population; higher for men and people with schizophrenia. Patients died about three decades prematurely, mainly from infectious causes (49.6%). Suicide, accidents and homicide were also common causes of death. CONCLUSIONS: Mortality is an important adverse outcome of SMI irrespective of setting. Addressing common natural and unnatural causes of mortality are urgent priorities. Premature death and mortality related to self-harm should be considered in the estimation of the global burden of disease for SMI.

Long-term clinical course and outcome of schizophrenia in rural Ethiopia: 10-year follow-up of a population-based cohort.

BACKGROUND: Although the few available studies from LMICs report favorable outcome, the course of schizophrenia is more complex than has been indicated so far. METHODS: A sample of 361 people with a standardized clinical diagnosis of schizophrenia were recruited from a predominantly rural community in Ethiopia and followed up regularly for an average of 10years. Psychiatrists used the Longitudinal Interval Follow-up Evaluation chart to carry out assessment of illness course. Duration of time in clinical remission was the primary outcome. RESULT: About 61.0% of the patients remained under active follow-up, while 18.1% (n=65) were deceased. The mean percentage of follow-up time in complete remission was 28.4% (SD=33.0). Female patients were significantly more likely to have episodic illness course with no inter-episode residual or negative symptoms (χ(2)=6.28, P=0.012). Nearly 14.0% had continuous psychotic symptoms for over 75% of their follow-up time. Only 18.1% achieved complete remission for over 75% of their follow-up time. Later onset of illness was the only significant predictor of achieving full remission for over 50% of follow-up time in a fully adjusted model. Conventional antipsychotic medications were fairly well tolerated in 80% of the patients and 4.2% (n=15) experienced tardive dyskinesia. CONCLUSION: This population-based study is one of the very few long-term outcome studies of schizophrenia in LMICs. The study demonstrated clearly a differential and more favorable course and outcome for female patients but overall course and outcome of schizophrenia appeared less favorable in this setting than has been reported from other LMICs.

Movement disorders in neuroleptic-naïve patients with schizophrenia spectrum disorders.

BACKGROUND: Spontaneous Movements Disorders (SMDs) or dyskinetic movements are often seen in patients with schizophrenia and other psychotic disorders, and are widely considered to be adverse consequences of the use of antipsychotic medications. Nevertheless, SMDs are also observed in the pre-neuroleptic ear and among patients who were never exposed to antipsychotic medications. The aim of this study was to determine the extent of SMDs among antipsychotic-naïve patients in a low income setting, and to evaluate contextually relevant risk factors. METHODS: The study was a cross-sectional facility-based survey conducted at a specialist psychiatric hospital in Addis Ababa, Ethiopia. Consecutive consenting treatment-naïve patients with a diagnosis of schizophrenia, schizoaffective disorder and schizophreniform disorder contacting services for the first time were assessed using the Simpson-Angus Rating Scale (SAS) and the Abnormal Involuntary Movement Scale (AIMS) to evaluate the presence of SMDS. Scale for the Assessment of Negative Symptoms (SANS) and Scale for the Assessment of Positive Symptoms (SAPS) were administered to evaluate negative and positive symptom profiles respectively. Body mass index (BMI) was used as a proxy measure for nutritional status. RESULT: Sixty-four patients, 67.2% male (n = 43), with first contact psychosis who met the DSM-IV-TR criteria for schizophrenia (n = 47), schizophreniform disorder (n= 5), and schizoaffective disorder (n = 12) were assessed over a two month study period. Seven patients (10.9%) had SMDs. BMI (OR = 0.6, 95% CI = 0.40, 0.89; p = 0.011) and increasing age (OR = 1.10; 95% CI = 1.02, 1.20; p = 0.017) were associated with SMD. CONCLUSIONS: This finding supports previous suggestions that abnormal involuntary movements in schizophrenia and other psychotic disorders may be related to the pathophysiology of psychotic disorders and therefore cannot be attributed entirely to the adverse effects of neuroleptic medication.

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.

Suicide and suicide attempts in people with severe mental disorders in Butajira, Ethiopia: 10 year follow-up of a population-based cohort.

BACKGROUND: People with severe mental disorders (SMD) are at higher risk of suicide. However, research into suicide attempts and completed suicide in people with SMD in low- and middle-income countries is mostly limited to patients attending psychiatric facilities where selection bias is likely to be high. METHODS: A population-based cohort of 919 people with SMD from rural Ethiopia (who received standardized clinician diagnoses of schizophrenia (n = 358) major depressive disorder (n = 216) and bipolar I disorder (n = 345)) were followed up annually for an average of 10 years. The Longitudinal Interval Follow-up Evaluation chart was administered by psychiatrists and used to evaluate systematically suicidal behavior and risk factors, which may be amenable to intervention. RESULTS: Over the follow-up period, the cumulative risk of suicide attempt was 26.3% for major depression, 23.8% for bipolar I disorder and 13.1% for schizophrenia, (p < 0.001). The overall incidence of completed suicide was 200.2/100,000 person-years (CI = 120.6, 312.5). Hanging was the most frequent method used (71.5%) for both attempters and completers. Most people who completed suicide were successful on the first attempt (84.2%), but the case-fatality rate for suicide attempt was 9.7%. In the adjusted logistic regression model, being currently married (Adjusted OR) =2.17, 95% CI = 1.21, 3.91), and having a diagnosis of bipolar I disorder (Adjusted OR = 2.59, 95% CI = 1.57, 4.26) or major depression (Adjusted OR = 2.71, 95% CI = 1.60, 4.58) were associated significantly with increased risk of suicide attempts. CONCLUSION: In this sample of people with SMD from a rural setting, the rate of suicide was high. Initiatives to integrate mental health service into primary care need to focus on limiting access to suicide methods in people with SMD in addition to expanding access to mental health care.

Violence and violent victimization in people with severe mental illness in a rural low-income country setting: a comparative cross-sectional community study.

BACKGROUND: Violence perpetrated by and against people with severe mental illness (SMI) is important but rarely investigated in low- and middle income countries. OBJECTIVE: To compare the prevalence of perpetrated violence and violent victimization, and associated factors, in people with and without SMI in rural Ethiopia. METHOD: A random sub-sample of people with a standardized, clinician diagnosis of SMI (n=201) was recruited from an existing population-based study and compared to a group of unaffected individuals from the same neighborhood (n=200). The lifetime and 12-month prevalence of violence and violent victimization was measured using an adapted version of the McArthur Violence Interview. RESULT: Lifetime and 12-month prevalence of perpetrated violence in people with SMI (28.4% and 17.4%, respectively) was significantly higher than in the non-mentally ill comparison group (15.0% and 8.5%, respectively). Male gender, being literate and violent victimization were associated independently with violence in both groups. In people with SMI, violence was associated additionally with being unmarried, exposure to stressful life events and non-response to medication. The prevalence of violent victimization was also significantly higher in people with SMI than those without SMI (60.7% vs. 41.5%). In people with SMI, violent victimization was associated with unemployment, non-adherence to treatment and being a perpetrator of violence. CONCLUSIONS: Our finding of high levels of violence and violent victimization in people with SMI underscores the need to improve access to mental health services in this setting, as well as the urgent need to raise awareness about victimization of people with SMI.

Adjuvant therapy with minocycline for schizophrenia (The MINOS Trial): study protocol for a double-blind randomized placebo-controlled trial.

BACKGROUND: Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions. The negative symptom dimension, with its protean cognitive manifestations, responds poorly to treatment, which can be a particular challenge in countries where clozapine therapy is not available. Preliminary data indicate that minocycline may be beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive symptoms.In this study we aim to assess the efficacy of adjunctive minocycline to alleviate symptoms of schizophrenia in patients who have failed to respond to a therapeutic trial of antipsychotic medications. METHODS: The study is a parallel group, double-blind, randomized, placebo-controlled trial. Participants will be adults (aged 18 years and above) with first episode or relapse episode of schizophrenia of under 5 years' duration. Patients who failed to show adequate therapeutic response to at least one antipsychotic medication given for a minimum of 4 weeks will be recruited from a psychiatry hospital in Addis Ababa and a psychiatry clinic in Butajira, Ethiopia. A total of 150 participants (75 in each arm) will be required to detect a five-point mean difference between the intervention arms adjusting for baseline symptom severity, at 90% power and 95% confidence. Patients in the intervention arm will receive minocycline (200 mg/day orally) added on to the regular antipsychotic medications participants are already on. Those in the placebo arm will receive an inactive compound identical in physical appearance to minocycline. Intervention will be offered for 12 weeks. Diagnosis will be established using the operational criteria for research (OPCRIT). Primary outcome measure will be a change in symptom severity measured using the positive and the negative syndrome scale for schizophrenia (PANSS). Secondary outcome measures will include changes in severity of negative symptoms, proportion achieving remission, and level of functioning. Whether changes are maintained post intervention will also be measured (PANSS). Key assessment for the primary outcome will be conducted at the end of trial (week 12). One post-intervention assessment will be conducted 4 weeks after the end of intervention (week 16) to determine sustainability of change. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01809158.

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.

Perspectives on reasons for non-adherence to medication in persons with schizophrenia in Ethiopia: a qualitative study of patients, caregivers and health workers.

BACKGROUND: Levels of non-adherence to antipsychotic medication in persons with schizophrenia in rural African settings have been shown to be comparable to those found in high-income countries. Improved understanding of the underlying reasons will help to inform intervention strategies relevant to the context. METHODS: A qualitative study was conducted among persons with schizophrenia (n = 24), their caregivers (n = 19), research field workers (n = 7) and health workers (n = 1) involved in the ongoing population-based cohort study, 'The Butajira Study on Course and Outcome of Schizophrenia and Bipolar Disorder', based in rural Ethiopia. Six focus group discussions and 9 in-depth interviews were conducted to elicit perspectives on non-adherence to antipsychotic medication. Thematic analysis was used to identify prominent perspectives. RESULTS: Predominant reasons for non-adherence specific to a low-income country setting included inadequate availability of food to counter appetite stimulation and the perceived strength of antipsychotic medications. The vital role of the family or other social support in the absence of a statutory social safety net was emphasised. Expectations of cure, rather than need for continuing care, were reported to contribute to non-adherence in the longer-term. Many of the factors associated with non-adherence in high-income countries were also considered important in Ethiopia, including lack of insight, failure to improve with treatment, medication side effects, substance abuse, stigma and dissatisfaction with the attitude of the care provider. CONCLUSION: This study identifies additional barriers to medication adherence faced by persons with schizophrenia in Ethiopia compared to those in high-income countries. In this era of scaling up of mental health care, greater attention to provision of social and financial assistance will potentially improve adherence and thereby enable patients to benefit more fully from medication.

Diagnostic validity of the composite international diagnostic interview (CIDI) depression module in an East African population.

OBJECTIVE: To evaluate the validity and reliability of the structured Composite International Diagnostic Interview (CIDI) in diagnosing current major depressive disorder (MDD) among East African adults. METHODS: A sample of 926 patients attending a major referral hospital in Ethiopia participated in this diagnostic assessment study. We used a two-stage study design where participants were first interviewed using an Amharic version of the CIDI and a stratified random sample underwent a follow-up semi-structured clinical interview conducted by a psychiatrist, blinded to the screening results, using the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) instrument. We tested construct validity by examining the association of the CIDI and World Health Organization Quality of Life (WHO-QOL) questionnaire. We calculated the psychometric properties of the CIDI using the SCAN diagnostic interview as a gold standard. RESULTS: We found that the Amharic version of the CIDI diagnostic interview has good internal reliability (Cronbach's alpha = 0.97) among Ethiopian adults. Compared to the SCAN reference standard, the CIDI had fair specificity (72.2%) but low sensitivity (51.0%). Our study provided evidence for unidimensionality of core depression screening questions on the CIDI interview with good factor loadings on a major core depressive factor. CONCLUSION: The Amharic language version of the CIDI had fair specificity and low sensitivity in detecting MDD compared with psychiatrist administered SCAN diagnosis. Our findings are generally consistent with prior studies. Use of fully structured interviews such as the CIDI for MDD diagnosis in clinical settings might lead to under-detection of DSM-IV MDD.

Magnitude, clinical and sociodemographic correlate of depression in diabetic patients, Addis Ababa, Ethiopia.

BACKGROUND: Depression is a major factor in causing hospital admissions and deaths in persons with diabetes mellitus. So far there is no study available on depression among Ethiopian diabetic patients. OBJECTIVE: This study aimed to determine the magnitude of clinical depression in diabetic patients and its association with the various clinical and sociodemographic factors related to diabetes mellitus. METHODS: 313 diabetic patients were selected from diabetic clinics of Black Lion & St. Paul hospitals, using systematic randomized sampling technique and assessed for over a period of three months, October - December 2009. Presence and severity of depression was evaluated using clinical interviews and a structured questionnaire, the Hamilton Depression Rating Scale. RESULTS: Of the total 313 patients, females account for 58.8% (n = 184), patients having type I diabetes 37.2% (n = 116) and type 2 diabetes 62.8% (n = 197). The average duration of illness with diabetes among male patients is found to be 8.2 +/- 6 years and 10.3 +/- 8 years for female patients. The mean duration of diabetes is 9.4 +/- 7.2 years. The magnitude of depression was 61% (n = 188) with mild, moderate, severe depression occurring in 40.9%, 14.7% and 4.5% of patients respectively. In this study depression diagnosed in 52.6% (n = 61) of type 1 DM and 64.8% (n = 127) of type 2 DM, 63% (n = 116) of females and 55.8% (n = 72) males. Occurrence of depression was more in patients with diabetic complications 68.2% (n = 107) and among patients in 36-54 years age group 66.7% (n = 80) compared to the rest age groups. The diagnosis of depression was also more prevalent in those with educational status below secondary level 63.9% (n = 152), (X2 = 5.868, P = 0.0075), among those with duration of DM greater than 5 yrs, 64.2% (n = 140) (X2 = 58.52, p < 0.023). CONCLUSION: Depression is an important psychiatric co morbidity in diabetic patients. The magnitude of depression in our study is significantly higher than reports from other countries. Raising awareness about co morbid emotional disorders in such chronic illnesses and availing effective treatment for depression with the basic diabetic care at these clinics may improve glycemia and diabetic related complications.