Psychometric properties of screening questionnaires to detect depression in primary healthcare setting in rural Ethiopia

Background: Much of the research about the validity of depression screening questionnaires is on criterion validity. Evidence is scarce on the concurrent, convergent and construct validity of these measures, particularly from low-income countries. This study aimed to evaluate the psychometric properties of depression screening questionnaires in primary healthcare (PHC) in rural Ethiopia. Methods: A facility-based cross-sectional study was conducted with 587 participants recruited from patients attending three PHC facilities and two ‘Holy water sites’ (places where religious treatment is being provided). The psychometric properties of five mental health screening questionnaires were evaluated: the nine item Patient Health Questionnaire (PHQ-9), the two item version of PHQ-9 (PHQ-2), a version of PHQ-9 with two added items of irritability and noise intolerance (PHQ-11), the Patient Health Questionnaire-15 (PHQ-15), and the World Health Organization-Five Well-being Index (WHO-5). Clinical diagnosis of depression was ascertained by psychiatrists. We analyzed data using exploratory factor analysis, Spearman’s rank order correlation coefficient (Rho), the Mann Whitney test of the equality of medians, univariate logistic regression and Cronbach’s alpha. Results: PHQ-9, PHQ-11 and WHO-5 were found to be unidimensional, with items in each scale highly loading onto one factor (factor loadings ranging from 0.64 to 0.87). The items of each instrument were internally consistent, with Cronbach’s alpha ranging from 0.72 (PHQ-2) to 0.89 (PHQ-11). Scores for all screening scales were moderately or highly correlated with each other (Rho = 0.58 to 0.98) and moderately correlated with anxiety and disability scores. Median scores of all screening scales were significantly higher in those diagnosed with depression. The association of items measuring emotional and cognitive symptoms with the diagnosis of depression was stronger than the association with items measuring somatic symptoms. Irritability and noise intolerance had higher association with depression diagnosis than PHQ-9 items. Conclusion: Emotional and cognitive symptoms are more useful than somatic symptoms to predict the diagnosis of depression in the PHC context in Ethiopia. Future research should focus on testing the unidimensionality of PHQ-9, PHQ-11 and WHO-5 using confirmatory factor analysis; establishing the criterion validity of PHQ-11 and WHO-5; and on assessing test-retest reliability of all the measures

"Like a doctor, like a brother" Achieving competence amongst lay health workers delivering community-based rehabilitation for people with schizophrenia in Ethiopia

BACKGROUND: There are gaps in our understanding of how non-specialists, such as lay health workers, can achieve core competencies to deliver psychosocial interventions in low- and middle-income countries.METHODS: We conducted a 12-month mixed-methods study alongside the Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE) pilot study. We rated a total of 30 role-plays and 55 clinical encounters of ten community-based rehabilitation (CBR) lay workers using an Ethiopian adaptation of the ENhancing Assessment of Common Therapeutic factors (ENACT) structured observational rating scale. To explore factors influencing competence, six focus group discussions and four in-depth interviews were conducted with 11 CBR workers and two supervisors at three time-points. We conducted a thematic analysis and triangulated the qualitative and quantitative data.RESULTS: There were improvements in CBR worker competence throughout the training and 12-month pilot study. Therapeutic alliance competencies (e.g., empathy) saw the earliest improvements. Competencies in personal factors (e.g., substance use) and external factors (e.g., assessing social networks) were initially rated lower, but scores improved during the pilot. Problem-solving and giving advice competencies saw the least improvements overall. Multimodal training, including role-plays, field work and group discussions, contributed to early development of competence. Initial stigma towards CBR participants was reduced through contact. Over time CBR workers occupied dual roles of expert and close friend for the people with schizophrenia in the programme. Competence was sustained through peer supervision, which also supported wellbeing. More intensive specialist supervision was needed.CONCLUSION: It is possible to equip lay health workers with the core competencies to deliver a psychosocial intervention for people with schizophrenia in a low-income setting. A prolonged period of work experience is needed to develop advanced skills such as problem-solving. A structured intervention with clear protocols, combined with peer supervision to support wellbeing, is recommended for good quality intervention delivery. Repeated ENACT assessments can feasibly and successfully be used to identify areas needing improvement and to guide on-going training and supervision

Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE): a 12 month mixed methods pilot study.

BACKGROUND: Community-based rehabilitation (CBR), or community-based inclusive development, is an approach to address the complex health, social and economic needs of people with schizophrenia in low and middle-income countries. Formative work was undertaken previously to design a culturally appropriate CBR intervention for people with schizophrenia in Ethiopia. The current study explored the acceptability and feasibility of CBR in practice, as well as how CBR may improve functioning among people with schizophrenia. METHODS: This mixed methods pilot study took place in rural Ethiopia between December 2014 and December 2015. Ten people with schizophrenia who were unresponsive to treatment with medication alone, and their caregivers, participated in CBR. CBR was led by lay workers with five weeks training and involved home visits (education, family intervention and support returning to work) and community mobilisation. Theory of change was used to guide the pilot evaluation. Qualitative and quantitative data were collected at baseline, six months and 12 months. Forty in-depth interviews and two focus group discussions were conducted with 31 individuals comprising people with schizophrenia, caregivers, CBR workers, supervisors, health officers and community members. RESULTS: The RISE CBR intervention may have a positive impact on functioning through the pathways of enhanced family support, improved access to health care, increased income and improved self-esteem. CBR was acceptable to CBR workers, community leaders and health officers. Some CBR workers found it challenging to accept the choices of people with schizophrenia. These concerns were felt to be resolvable with supplementary training for CBR workers. The intervention was feasible but further evaluation is needed on a larger scale. CONCLUSION: In low and middle-income countries, CBR may be an acceptable and feasible adjuvant approach to facility-based care for people with schizophrenia. However, contextual factors, including poverty and inaccessible anti-psychotic medication, remain substantial challenges. There were indications that CBR can impact on functioning but the RISE trial will determine effectiveness

Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE) cluster-randomised controlled trial:An exploratory analysis of impact on food insecurity, underweight, alcohol use disorder and depressive symptoms

We evaluated the effectiveness of community-based rehabilitation (CBR) in reducing depressive symptoms, alcohol use disorder, food insecurity and underweight in people with schizophrenia. This cluster-randomised controlled trial was conducted in a rural district of Ethiopia. Fifty-four sub-districts were allocated in a 1:1 ratio to the facility-based care [FBC] plus CBR arm and the FBC alone arm. Lay workers delivered CBR over 12 months. We assessed food insecurity (self-reported hunger), underweight (BMI< 18.5 kg/m2), depressive symptoms (PHQ-9) and alcohol use disorder (AUDIT ≥ 8) at 6 and 12 months. Seventy-nine participants with schizophrenia in 24 sub-districts were assigned to CBR plus FBC and 87 participants in 24 sub-districts were assigned to FBC only. There was no evidence of an intervention effect on food insecurity (aOR 0.52, 95% CI 0.16-1.67; p = 0.27), underweight (aOR 0.44, 95% CI 0.17-1.12; p = 0.08), alcohol use disorder (aOR 0.82, 95% CI 0.24-2.74; p = 0.74) or depressive symptoms (adjusted mean difference - 0.06, 95% CI -1.35, 1.22; p = 0.92). Psychosocial interventions in low-resource settings should support access to treatment amongst people with schizophrenia, and further research should explore how impacts on economic, physical and mental health outcomes can be achieved

Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE):results of a 12-month cluster-randomised controlled trial

BACKGROUND: Community-based rehabilitation (CBR) is recommended to address the social and clinical needs of people with schizophrenia in resource-poor settings. We evaluated the effectiveness of CBR at reducing disability at 12 months in people with schizophrenia who had disabling illness after having had the opportunity to access facility-based care for 6 months METHODS: This cluster-randomised controlled trial was conducted in a rural district of Ethiopia. Eligible clusters were subdistricts in Sodo district that had not participated in the pilot study. Available subdistricts were randomised (in a 1:1 ratio) to either the intervention group (CBR plus facility-based care) or to the control group (facility-based care alone). An optimisation procedure (accounting for the subdistrict mean WHO Disability Assessment Schedule (WHODAS) score and the potential number of participants per subdistrict) was applied for each of the eight health facilities in the district. An independent statistician, masked to the intervention or control label, used a computer programme to randomly choose the allocation sequence from the set of optimal ones. We recruited adults with disabling illness as a result of schizophrenia. The subdistricts were eligible for inclusion if they included participants that met the eligibility criteria. Researchers recruiting and assessing participants were masked to allocation status. Facility-based care was a task-shared model of mental health care integrated within primary care. CBR was delivered by lay workers over a 12-month period, comprising of home visits (psychoeducation, adherence support, family intervention, and crisis management) and community mobilisation. The primary outcome was disability, measured with the proxy-rated 36-item WHODAS score at 12 months. The subdistricts that had primary outcome data available were included in the primary analysis. This study is registered with ClinicalTrials.gov, NCT02160249.FINDINGS: Enrolment took place between Sept 16, 2015 and Mar 11, 2016. 54 subdistricts were randomised (27 to the CBR plus facility-based care group and 27 to the facility-based care group). After exclusion of subdistricts without eligible participants, we enrolled 79 participants (66% men and 34% women) from 24 subdistricts assigned to CBR plus facility-based care and 87 participants (59% men and 41% women) from 24 subdistricts assigned to facility-based care only. The primary analysis included 149 (90%) participants in 46 subdistricts (73 participants in 22 subdistricts in the CBR plus facility-based care group and 76 participants in 24 subdistricts in the facility-based care group). At 12 months, the mean WHODAS scores were 46·1 (SD 23·3) in the facility-based care group and 40·6 (22·5) in the CBR plus facility-based care group, indicating a favourable intervention effect (adjusted mean difference -8·13 [95% CI -15·85 to -0·40]; p=0·039; effect size 0·35). Four (5%) CBR plus facility-based care group participants and nine (10%) facility-based care group participants had one or more serious adverse events (death, suicide attempt, and hospitalisation).INTERPRETATION: CBR delivered by lay workers combined with task-shared facility-based care, was effective in reducing disability among people with schizophrenia. The RISE study CBR model is particularly relevant to low-income countries with few mental health specialists.FUNDING: Wellcome Trust

Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

BACKGROUND: Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia. METHODS: This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample size will allow us to detect a 20 % difference in WHODAS 2.0 scores between treatment arms with 85 % power. Secondary outcomes include change in symptom severity, economic activity, physical restraint, discrimination and caregiver burden. DISCUSSION: This is the first trial of community-based rehabilitation for schizophrenia and will determine, as a proof of concept, the added value of community-based rehabilitation compared to facility-based care alone in a low-income country with scarce mental health resources. TRIAL REGISTRATION: Clinical Trials.gov Identifier NCT02160249 . Registered on 3 June 2014

“Like a doctor, like a brother”: achieving competence amongst lay health workers delivering community-based rehabilitation for people with schizophrenia in Ethiopia

BackgroundThere are gaps in our understanding of how non-specialists, such as lay health workers, can achieve core competencies to deliver psychosocial interventions in low- and middle-income countries.MethodsWe conducted a 12-month mixed-methods study alongside the Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE) pilot study. We rated a total of 30 role-plays and 55 clinical encounters of ten community-based rehabilitation (CBR) lay workers using an Ethiopian adaptation of the ENhancing Assessment of Common Therapeutic factors (ENACT) structured observational rating scale. To explore factors influencing competence, six focus group discussions and four in-depth interviews were conducted with 11 CBR workers and two supervisors at three time-points. We conducted a thematic analysis and triangulated the qualitative and quantitative data.Results There were improvements in CBR worker competence throughout the training and 12-month pilot study. Therapeutic alliance competencies (e.g., empathy) saw the earliest improvements. Competencies in personal factors (e.g., substance use) and external factors (e.g., assessing social networks) were initially rated lower, but scores improved during the pilot. Problem-solving and giving advice competencies saw the least improvements overall. Multimodal training, including role-plays, field work and group discussions, contributed to early development of competence. Initial stigma towards CBR participants was reduced through contact. Over time CBR workers occupied dual roles of expert and close friend for the people with schizophrenia in the programme. Competence was sustained through peer supervision, which also supported wellbeing. More intensive specialist supervision was needed. ConclusionIt is possible to equip lay health workers with the core competencies to deliver a psychosocial intervention for people with schizophrenia in a low-income setting. A prolonged period of work experience is needed to develop advanced skills such as problem-solving. A structured intervention with clear protocols, combined with peer supervision to support wellbeing, is recommended for good quality intervention delivery. Repeated ENACT assessments can feasibly and successfully be used to identify areas needing improvement and to guide on-going training and supervision

Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE) cluster-randomized controlled trial: an exploratory analysis of impact on food insecurity, underweight, alcohol use disorder and depressive symptoms

We evaluated the effectiveness of community-based rehabilitation (CBR) in reducing depressive symptoms, alcohol use disorder, food insecurity and underweight in people with schizophrenia. This cluster-randomised controlled trial was conducted in a rural district of Ethiopia. Fifty-four sub-districts were allocated in a 1:1 ratio to the facility-based care [FBC] plus CBR arm and the FBC alone arm. Lay workers delivered CBR over 12 months. We assessed food insecurity (self-reported hunger), underweight (BMI< 18.5 kg/m2), depressive symptoms (PHQ-9) and alcohol use disorder (AUDIT ≥ 8) at 6 and 12 months. Seventy-nine participants with schizophrenia in 24 sub-districts were assigned to CBR plus FBC and 87 participants in 24 sub-districts were assigned to FBC only. There was no evidence of an intervention effect on food insecurity (aOR 0.52, 95% CI 0.16-1.67; p = 0.27), underweight (aOR 0.44, 95% CI 0.17-1.12; p = 0.08), alcohol use disorder (aOR 0.82, 95% CI 0.24-2.74; p = 0.74) or depressive symptoms (adjusted mean difference - 0.06, 95% CI -1.35, 1.22; p = 0.92). Psychosocial interventions in low-resource settings should support access to treatment amongst people with schizophrenia, and further research should explore how impacts on economic, physical and mental health outcomes can be achieved

Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE): results of a 12-month cluster-randomised controlled trial

Background Community-based rehabilitation (CBR) is recommended to address the social and clinical needs of people with schizophrenia in resource-poor settings. We evaluated the effectiveness of CBR at reducing disability at 12 months in people with schizophrenia who had disabling illness after having had the opportunity to access facility-based care for 6 months Methods This cluster-randomised controlled trial was conducted in a rural district of Ethiopia. Eligible clusters were subdistricts in Sodo district that had not participated in the pilot study. Available subdistricts were randomised (in a 1:1 ratio) to either the intervention group (CBR plus facility-based care) or to the control group (facility-based care alone). An optimisation procedure (accounting for the subdistrict mean WHO Disability Assessment Schedule (WHODAS) score and the potential number of participants per subdistrict) was applied for each of the eight health facilities in the district. An independent statistician, masked to the intervention or control label, used a computer programme to randomly choose the allocation sequence from the set of optimal ones. We recruited adults with disabling illness as a result of schizophrenia. The subdistricts were eligible for inclusion if they included participants that met the eligibility criteria. Researchers recruiting and assessing participants were masked to allocation status. Facility-based care was a task-shared model of mental health care integrated within primary care. CBR was delivered by lay workers over a 12-month period, comprising of home visits (psychoeducation, adherence support, family intervention, and crisis management) and community mobilisation. The primary outcome was disability, measured with the proxy-rated 36-item WHODAS score at 12 months. The subdistricts that had primary outcome data available were included in the primary analysis. This study is registered with ClinicalTrials.gov, NCT02160249. Findings Enrolment took place between Sept 16, 2015 and Mar 11, 2016. 54 subdistricts were randomised (27 to the CBR plus facility-based care group and 27 to the facility-based care group). After exclusion of subdistricts without eligible participants, we enrolled 79 participants (66% men and 34% women) from 24 subdistricts assigned to CBR plus facility-based care and 87 participants (59% men and 41% women) from 24 subdistricts assigned to facility-based care only. The primary analysis included 149 (90%) participants in 46 subdistricts (73 participants in 22 subdistricts in the CBR plus facility-based care group and 76 participants in 24 subdistricts in the facility-based care group). At 12 months, the mean WHODAS scores were 46·1 (SD 23·3) in the facility-based care group and 40·6 (22·5) in the CBR plus facility-based care group, indicating a favourable intervention effect (adjusted mean difference −8·13 [95% CI −15·85 to −0·40]; p=0·039; effect size 0·35). Four (5%) CBR plus facility-based care group participants and nine (10%) facility-based care group participants had one or more serious adverse events (death, suicide attempt, and hospitalisation). Interpretation CBR delivered by lay workers combined with task-shared facility-based care, was effective in reducing disability among people with schizophrenia. The RISE study CBR model is particularly relevant to low-income countries with few mental health specialists. Funding Wellcome Trust

Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE): results of a 12-month cluster-randomised controlled trial

Background:Community-based rehabilitation (CBR) is recommended to address the social and clinical needs of people with schizophrenia in resource-poor settings. We evaluated the effectiveness of CBR in reducing disability at 12 months in persons with schizophrenia who had disabling illness after six months access to standard care. Methods: This cluster-randomized controlled trial was conducted in a rural district of Ethiopia. We recruited adults with schizophrenia with disabling illness. 54 sub-districts were allocated in a 1:1 ratio to the intervention arm (facility-based care (FBC) plus CBR) or the control arm (FBC alone). FBC was a task-shared model of mental healthcare integrated within primary care. CBR was delivered by lay workers over 12 months and comprised home visits (psychoeducation, adherence support, family intervention, crisis management) and community mobilization. The primary outcome was disability, measured with the proxy-rated 36-item WHO Disability Assessment Schedule (WHODAS) at 12 months. The analyses used intention-to-treat principles. Trial registration: ClinicalTrials.gov, NCT02160249. Findings: Participants were enrolled between Sept 16, 2015 and Mar 11, 2016. Sub-districts without eligible participants were excluded. 79 participants in 24 sub-districts were assigned to CBR plus FBC and 87 participants in 24 sub-districts were assigned to FBC only. The primary analysis included 149 (89.8%) participants in 46 sub-districts. At 12 months, the mean WHODAS scores were 46.1 (SD 23.3) in the control arm and 40.6 (SD 22.5) in the intervention arm, indicating a favourable intervention effect (adjusted mean difference -8·13, 95%CI -15·85 to -0·40; p=0·039; effect size 0·35). Four (5·1%) intervention arm participants and nine (10·3%) control arm participants had at ≥1 serious adverse event (death, suicide attempt and hospitalization)