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Background: The treatment gap for mental health services is a growing public health concern. A lay-counselling service located at primary health care (PHC) level could potentially help to close the large treatment gap for common mental disorders in South Africa. The aim of this study was to understand multilevel factors contributing to implementation and potential dissemination of such a service for depression at PHC level. Methods: Process qualitative data of the lay-counselling service for patients with depressive symptoms was collected alongside a pragmatic randomized controlled trial evaluating a collaborative care model that included a lay-counselling service for patients with depressive symptoms. Semi-structured key informant interviews (SSI) were conducted with a purposive sample of PHC providers (lay-counsellors, nurse practitioners, operational managers), lay-counsellor supervisors, district and provincial managers, and patients in receipt of services. A total of 86 interviews were conducted. The Consolidated Framework for Implementation Research (CFIR) was used to guide data collection as well as Framework Analysis to determine barriers and facilitators for implementation and dissemination of the lay-counselling service. Results: Facilitators identified include supervision and support available for counsellors; person focused counselling approach; organizational integration of the counsellor within facilities. Barriers included lack of organizational support of the counselling service, including lack of counselling dedicated space; high counsellor turnover, resulting in a counsellor not available all the time; lack of an identified cadre to deliver the intervention in the system; and treatment of mental health conditions including counselling not included within mental health indicators. Conclusions: Several system level issues need to be addressed to promote integration and dissemination of lay-counselling services within PHC facilities in South Africa. Key system requirements are facility organizational readiness for improvement of integration of lay-counselling services; formal recognition of counselling services provided by lay counsellors as well as inclusion of lay counselling as a treatment modality within mental health treatment data element definitions and the need for diversification of the roles of psychologists to include training and supervision of lay counsellors was also emphasized. [ABSTRACT FROM AUTHOR]

Introduction: A task-sharing collaborative care model for integrated depression care for South Africa's burgeoning primary health care population with chronic conditions was developed and tested through two pragmatic cluster randomized controlled trials. One trial focused on patients with hypertension and was located in one district where a collaborative care model was co-designed with district stakeholders. The other trial, focused on patients on antiretroviral treatment, was located in the same district site, with the addition of a second neighbouring district, without adaptation of the original model. This paper describes the package used to implement this model, and implementation outcomes across the two sites, and summarises lessons and challenges. Methods: The Template for Intervention Description and Replication (TIDieR) framework, adapted for complex health systems interventions, was used to describe components of the package. Additional elements of 'modifications made' and 'actual implementation' introduced in the 'Getting messier with TIDieR' framework, were used to describe implementation outcomes in terms of reach, adoption and implementation across the two trial districts. Results: In the absence of a co-design process to adapt the model to the context of the second site, there was less system level support for the model. Consequently, more project employed human resources were deployed to support training of primary care nurses in identification and referral of patients with depression; and supervise co-located lay counsellors. Referrals to co-located lay counselling services were more than double in the second site. However, uptake of counselling sessions was greater in the first site. This was attributed to greater in-vivo supervision and support from existing mental health specialists in the system. There was greater reliance on online supervision and support in the second site where geographical distances between clinics were larger. Conclusion: The need for in-country co-designed collaborative care models, and 'implementation heavy' implementation research to understand adaptations required to accommodate varying in-country health system contexts is highlighted. [ABSTRACT FROM AUTHOR]

This study investigated a non-specialist delivered programme for psychosocial rehabilitation for service users with schizophrenia in a low-resource South African setting. Forty-four service users with schizophrenia living in the community, receiving ongoing medication through primary care, participated in a structured support group. Quantitative measures (WHODAS 12 item, Brief Psychiatric Rating Scale and Internalized Stigma of Mental Illness Inventory) were assessed at baseline and 12 months. Sixteen service users were interviewed on their experiences. WHODAS data showed a small reduction. ISMI assessment showed a statistically significant reduction. Qualitative data revealed: improved self-esteem and increased illness knowledge, reduced risk taking, reduced social isolation and improved pro-social behavior, improved financial management and engagement in income generation activities as well as improved acceptance by the community. This study provides preliminary evidence on the benefits of this programme that warrant further study incorporating experimental methods. [ABSTRACT FROM AUTHOR]

Introduction: A task-sharing collaborative care model for integrated depression care for South Africa's burgeoning primary health care population with chronic conditions was developed and tested through two pragmatic cluster randomized controlled trials. One trial focused on patients with hypertension and was located in one district where a collaborative care model was co-designed with district stakeholders. The other trial, focused on patients on antiretroviral treatment, was located in the same district site, with the addition of a second neighbouring district, without adaptation of the original model. This paper describes the package used to implement this model, and implementation outcomes across the two sites, and summarises lessons and challenges.Methods: The Template for Intervention Description and Replication (TIDieR) framework, adapted for complex health systems interventions, was used to describe components of the package. Additional elements of 'modifications made' and 'actual implementation' introduced in the 'Getting messier with TIDieR' framework, were used to describe implementation outcomes in terms of reach, adoption and implementation across the two trial districts.Results: In the absence of a co-design process to adapt the model to the context of the second site, there was less system level support for the model. Consequently, more project employed human resources were deployed to support training of primary care nurses in identification and referral of patients with depression; and supervise co-located lay counsellors. Referrals to co-located lay counselling services were more than double in the second site. However, uptake of counselling sessions was greater in the first site. This was attributed to greater in-vivo supervision and support from existing mental health specialists in the system. There was greater reliance on online supervision and support in the second site where geographical distances between clinics were larger.Conclusion: The need for in-country co-designed collaborative care models, and 'implementation heavy' implementation research to understand adaptations required to accommodate varying in-country health system contexts is highlighted. [ABSTRACT FROM AUTHOR]

Background: In the context of a large treatment gap for common mental disorders (CMDs) and shortage of mental health specialists in low- and middle-income countries, there is increasing evidence of the effectiveness of task sharing of counselling interventions to increase access to mental health care for CMDs at primary health care level. This study evaluated the relationship between levels of exposure to a task-shared counselling intervention and psychosocial outcomes (depression, functional disability, internalised stigma and social support) in chronic care service users with comorbid depression in South Africa guided by the Medical Research Council process evaluation framework. Implementation and participant-level factors that promote greater exposure were also investigated. Method: The study design was a cohort study comprising of 173 participants referred by primary health care nurses for the task-shared counselling intervention. The study site comprised four primary health care facilities in a sub-district of the Dr. Kenneth Kaunda district in the North West Province of South Africa. The participants were assessed for psychosocial outcomes at three time points: baseline, 3 months and at 12 months. The number of counselling sessions each participant was exposed to was collected for each participant. Linear regression models were used to test the influence of counselling exposure on each of the psychosocial variables between baseline and endline. In-depth qualitative interviews were conducted on 29 randomly selected participants, stratified according to exposure to counselling sessions, and analysed using framework analysis. Findings: Findings from the cohort study indicated a significant reduction in depression severity at 12 months. Internalised stigma and functional disability improved from baseline to endline. Participants receiving 5–8 sessions have the greatest reduction in PHQ9 scores from baseline to endline (β = − 2.46, 95% CI − 5.06 to 0.15) compared to those with 0 sessions (β = − 0.51, 95% CI − 3.62 to 2.60, p = 0.064). The WHODAS scores decreased significantly more from baseline to endline among those who received 5–8 sessions (β = − 10.73, 95% CI − 19.86 to 1.59) compared to those with 0 sessions (β = 2.25, 95% CI − 8.65 to 13.14, p = 0.021). No significant differences as a function of levels of counselling exposure from baseline to endline was observed for OSS-3 scores. An improvement in ISMI scores from 1–4 sessions to 5–8 sessions was found (β = − 4.05, 95% CI − 7.30 to − 0.80, p = 0.015). The qualitative process evaluation indicated that the service was acceptable and accessible; but that session attendance was hindered by women's' caregiving burden, poor counsellor attributes and poor referral processes. Conclusion: Exposure to a greater number of sessions (5–8 sessions) was found to optimize functional ability, reduce stigma, and potentially reduce depression symptoms. In order to enhance session attendance, lay counsellor delivered psychosocial interventions need to pay attention to (i) counsellor selection criteria, particularly person-centred care qualities; and (ii) strengthening referral processes in contexts where mental health literacy is low. [ABSTRACT FROM AUTHOR]

Psychosocial support is recognized as important for recovery for service users with schizophrenia, in addition to provision of antipsychotic medication. This study aimed to develop a community-based psychosocial rehabilitation programme for service users with schizophrenia to be facilitated by auxiliary social workers, and to investigate acceptability and feasibility of the programme. A task-sharing approach was adopted in which auxiliary social workers were trained to facilitate psychosocial rehabilitation groups. In-depth individual qualitative interviews were conducted with six group members at baseline, midpoint, and endpoint (18 interviews in total). NVivo10 was used to store data and conduct qualitative framework analysis. Participants reported benefits of the programme, including improvements in group members’ self-esteem, social support, illness knowledge, self-care, and contribution to their households. A key barrier to acceptability was the lack of provision of income generating opportunities. Implementation challenges include difficulties in tracing and engaging service users and families, lack of an appropriate venue, and issues with supply of antipsychotic medication. This study has provided evidence for the benefits and acceptability of this contextually adapted programme. Key barriers to implementation can be addressed through the provision of the necessary resources for auxiliary social worker input in the community. [ABSTRACT FROM AUTHOR]

Background: People with chronic health conditions are known to have a higher prevalence of depressive disorder. The Patient Health Questionnaire (PHQ-9) is a widely-used screening tool for depression which has not yet been validated for use on chronic care patients in South Africa. Methods: A sample of 676 chronic care patients attending two primary health facilities in North West Province, South Africa were administered the PHQ-9 by field workers and a diagnostic interview (the Structured Clinical Interview for DSM-IV) (SCID) by clinical psychologists. The PHQ-9 and the PHQ-2 were evaluated against the SCID, as well as for sub-samples of patients who were being treated for HIV infection and for hypertension. Results: Using the SCID, 11.4 % of patients had major depressive disorder. The internal consistency estimate for the PHQ-9 was 0.76, with an area under the receiver operator curve (AUROC) of 0.85 (95 % CI 0.82-0.88), which was higher than the AURUC for the PHQ-2 (0.76, 95 % CI 0.73-0.79). Using a cut-point of 9, the PHQ-9 has sensitivity of 51 % and specificity of 94 %. The PHQ-9 AUROC for the sub-samples of patients with HIV and with hypertension were comparable (0.85 and 0.86, respectively). Conclusions: The PHQ-9 is useful as a screening tool for depression among patients receiving treatment for chronic care in a public health facility. [ABSTRACT FROM AUTHOR]

Background: We tested the real-world effectiveness of a collaborative task-sharing model on depressive symptom reduction in hypertensive Primary Health Care (PHC) patients in South Africa.Method: A pragmatic parallel cluster randomised trial in 20 clinics in the Dr Kenneth Kaunda district, North West province. PHC clinics were stratified by sub-district and randomised in a 1:1 ratio. Control clinics received care as usual (CAU), involving referral to PHC doctors and/or mental health specialists. Intervention clinics received CAU plus enhanced mental health training and a lay counselling referral service. Participant inclusion criteria were ≥ 18 years old, Patient Health Questionnaire-9 (PHQ-9) score ≥ 9 and receiving hypertension medication. Primary superiority outcome was ≥ 50% reduction in PHQ-9 score at 6 months. Statistical analyses comprised mixed effects regression models and a non-inferiority analysis.Trial Registration Number: NCT02425124.Results: Between April 2015 and October 2015, 1043 participants were enrolled (504 intervention and 539 control); 82% were women; half were ≥ 55 years. At 6 and 12 months follow-up, 91% and 89% of participants were interviewed respectively. One control group participant committed suicide. There was no significant difference in the primary outcome between intervention (N=256/456) and control (N=232/492) groups (55.9% versus 50.9%; adjusted risk difference = -0.04 ([95% CI = -0.19; 0.11], p = 0.6). The difference in PHQ-9 scores was within the defined equivalence limits at 6 and 12 months for the non-inferiority analysis.Limitations: The trial was limited by low exposure to depression treatment by trial participants and by observed co-intervention in control clinics CONCLUSIONS: Incorporating lay counselling services within collaborative care models does not produce superior nor inferior outcomes to models with specialist only counselling services.Funding: This work was supported by the UK Department for International Development [201446] as well as the National Institute of Mental Health, United States of America, grant number 1R01MH100470-01. Graham Thornicroft is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King's College London and King's College Hospital NHS Foundation Trust. [ABSTRACT FROM AUTHOR]

Integrating mental health services into primary healthcare platforms is an established health systems strategy in low-to-middle-income countries. In South Africa, this was pursued through the Programme for Improving Mental Health Care (PRIME), a multi-country initiative that relied on task-sharing as a principle implementation strategy. Towards better describing the implementation processes, qualitative comparative analysis was adopted to explore causal pathways in the intervention. This study aimed to explore factors that could have influenced key outcomes of an integrated mental healthcare intervention in South Africa. Drawing from an embedded multiple case study design, the analysis used qualitative comparative analysis. Focusing on nine PHC clinics in the Dr Kenneth Kaunda District as cases, with depression reduction scores set as outcome measures, trial data variables were modelled in a hypothetical causal process. A fuzzy-set qualitative comparative analysis was performed by 1) developing the research questions, 2) developing the fuzzy set, 3) testing necessity and 4) testing sufficiency. These steps were undertaken collaboratively among the research team. The data were calibrated during several meetings among team members to gain a degree of consensus. Necessity analyses suggested that none of the causal conditions exceeded the threshold of necessity and triviality, and confirmed the inclusion of relevant variables in line with the proposed models. Sufficiency analyses produced two configurations, which were subjected to standard and specific analyses. Ultimately, the results suggested that none of the causal conditions were necessary for a reduction in depression scores to occur, while programme fidelity was identified as a sufficient condition for a reduction in scores to occur. The study highlights the importance of understanding implementation pathways to enable better integration of mental health services within primary healthcare in low-to-middle-income settings. It underlines the importance of programme fidelity in achieving the goals of implementation. [ABSTRACT FROM AUTHOR]

Background: The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA).Methods/design: The study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months.Discussion: This trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa.Trial Registration: South African National Clinical Trial Register: SANCTR ( http://www.sanctr.gov.za/SAClinicalTrials ) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov : ID: NCT02425124 . Registered on 22 April 2015. [ABSTRACT FROM AUTHOR]

Background: The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART.Methods: The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health's Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women's health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively.Discussion: The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings.Trial Registration: ClinicalTrials.gov ( NCT02407691 ) registered on 19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015. [ABSTRACT FROM AUTHOR]

recovery for people in need of mental health services. Yet there is scarce research investigating the experiences of psychiatric stigma on mental health service users in low- and middle-income countries (LMICs). The aim of this study was therefore to explore the experiences of psychiatric stigma by service users in order to inform interventions to reduce such stigma and discrimination in one LMIC, namely South Africa. Methods: Participants comprised a total of 77 adults aged above 18 years, made up of service providers including professional nurses (10), lay counsellors (20), auxiliary social workers (2); and service users (45). Results: Psychiatric stigma was found to be perpetuated by family members, friends, employers, community members and health care providers. Causes of psychiatric stigma identified included misconceptions about mental illness often leading to delays in help-seeking. Experiencing psychiatric stigma was reported to worsen the health of service users and impede their capacity to lead and recover a normal life. Conclusion: Media campaigns and interventions to reduce stigma should be designed to address specific stigmatizing behaviours among specific segments of the population. Counselling of families, caregivers and service users should include how to deal with experienced and internalized stigma. [ABSTRACT FROM AUTHOR]

An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]

Background: The rise in multimorbid chronic conditions in South Africa, large treatment gap for common mental disorders (CMDs) and shortage of mental health specialists demands a task sharing approach to chronic disease management that includes treatment for co-existing CMDs to improve health outcomes. The aim of this study was thus to evaluate a task shared integrated collaborative care package of care for chronic patients with co-existing depressive and alcohol use disorder (AUD) symptoms. Methods: The complex intervention strengthened capacity of primary care nurse practitioners to identify, diagnose and review symptoms of CMDs among chronic care patients; and implemented a stepped up referral system, that included clinic-based psychosocial lay counsellors, doctors and mental health specialists. Under real world conditions, in four PHC facilities, a repeat cross-sectional Facility Detection Survey (FDS) assessed changes in capacity of nurses to correctly detect CMDs in 1310 patients before implementation and 1246 patients following implementation of the intervention at 12 months; and a non-randomly assigned comparison group cohort study comprising 373 screen positive patients with depressive symptoms using the Patient Health Questionnaire-9 (PHQ9) at baseline, evaluated responses of patients correctly identified and referred for treatment (intervention arm) or not identified and referred (control arm) at three and 12 months. Results: The FDS showed a significant increase in the identification of depression and AUD from pre-implementation to 12-month post-implementation. Depression: (5.8 to 16.4%) 95% CI [2.9, 19.1]); AUD: (0 to 13.8%) 95% CI [0.6–24.9]. In the comparison group cohort study, patients with depressive symptoms having more than a 50% reduction in PHQ-9 scores were greater in the treatment group (n = 69, 55.2%) compared to the comparison group (n = 49, 23.4%) at 3 months (RR = 2.10, p < 0.001); and 12 months follow-up (intervention: n = 57, 47.9%; comparison: n = 60, 30.8%; RR = 1.52, p = 0.006). Remission (PHQ-9 ≤ 5) was greater in the intervention group (n = 32, 26.9%) than comparison group (n = 33, 16.9%) at 12 months (RR = 1.72, p = 0.016). Conclusion: A task shared collaborative stepped care model can improve detection of CMDs and reduce depressive symptoms among patients with chronic conditions under real world conditions. [ABSTRACT FROM AUTHOR]

Background: The Programme for Improving Mental Health Care (PRIME) sought to implement mental health care plans (MHCP) for four priority mental disorders (depression, alcohol use disorder, psychosis and epilepsy) into routine primary care in five low- and middle-income country districts. The impact of the MHCPs on disability was evaluated through establishment of priority disorder treatment cohorts. This paper describes the methodology of these PRIME cohorts. Methods: One cohort for each disorder was recruited across some or all five districts: Sodo (Ethiopia), Sehore (India), Chitwan (Nepal), Dr. Kenneth Kaunda (South Africa) and Kamuli (Uganda), comprising 17 treatment cohorts in total (N = 2182). Participants were adults residing in the districts who were eligible to receive mental health treatment according to primary health care staff, trained by PRIME facilitators as per the district MHCP. Patients who screened positive for depression or AUD and who were not given a diagnosis by their clinicians (N = 709) were also recruited into comparison cohorts in Ethiopia, India, Nepal and South Africa. Caregivers of patients with epilepsy or psychosis were also recruited (N = 953), together with or on behalf of the person with a mental disorder, depending on the district. The target sample size was 200 (depression and AUD), or 150 (psychosis and epilepsy) patients initiating treatment in each recruiting district. Data collection activities were conducted by PRIME research teams. Participants completed follow-up assessments after 3 months (AUD and depression) or 6 months (psychosis and epilepsy), and after 12 months. Primary outcomes were impaired functioning, using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS), and symptom severity, assessed using the Patient Health Questionnaire (depression), the Alcohol Use Disorder Identification Test (AUD), and number of seizures (epilepsy). Discussion: Cohort recruitment was a function of the clinical detection rate by primary health care staff, and did not meet all planned targets. The cross-country methodology reflected the pragmatic nature of the PRIME cohorts: while the heterogeneity in methods of recruitment was a consequence of differences in health systems and MHCPs, the use of the WHODAS as primary outcome measure will allow for comparison of functioning recovery across sites and disorders. [ABSTRACT FROM AUTHOR]