Addressing the challenges of integrating care for perinatal depression in primary care in Nigeria.

PURPOSE: This report provides the results of a task-shared approach for integrating care for perinatal depression (PND) within primary maternal and child healthcare (PMCH), including the factors that may facilitate or impede the process. METHODS: This hybrid implementation-effectiveness study guided by the Replicating Effective Programmes framework was conducted in 27 PMCH clinics in Ibadan, Nigeria. The primary implementation outcome was change in the identification rates of PND by primary health care workers (PHCW) while the primary effectiveness outcome was the difference in symptom remission (EPDS score ≤ 5) 6 months postpartum. Outcome measures were compared between two cohorts of pregnant women, one recruited before and the other after training PHCW to identify and treat PND. Barriers and facilitators were explored in qualitative interviews. RESULTS: Identification of PND improved from 1.4% before to 17.4% after training; post-training rate was significantly higher in clinics where PHCW routinely screened using the 2-item patient health questionnaire (24.8%) compared to non-screening clinics (5.6%). At 6-months postpartum, 60% of cohort one experienced remission from depression, compared to 56.5% cohort two [OR-0.9 (95%CI-0.6, 1.3) p = 0.58]. Identified facilitators for successful integration included existence of policy specifying mental health as a component of PHC, use of screening to aid identification and supportive supervision, while barriers included language and cultural attitudes towards mental health and human resource constraints. PHCW were able to make adaptations to address these barriers. CONCLUSIONS: Successful implementation of task-shared care for perinatal depression requires addressing staff shortages and adopting strategies that can improve identification by non-specialist providers. TRIAL REGISTRATION: This study was retrospectively registered 03 Dec 2019. https://doi.org/10.1186/ISRCTN94230307 .

Antidepressant use in low- middle- and high-income countries: a World Mental Health Surveys report.

BACKGROUND: The most common treatment for major depressive disorder (MDD) is antidepressant medication (ADM). Results are reported on frequency of ADM use, reasons for use, and perceived effectiveness of use in general population surveys across 20 countries. METHODS: Face-to-face interviews with community samples totaling n = 49 919 respondents in the World Health Organization (WHO) World Mental Health (WMH) Surveys asked about ADM use anytime in the prior 12 months in conjunction with validated fully structured diagnostic interviews. Treatment questions were administered independently of diagnoses and asked of all respondents. RESULTS: 3.1% of respondents reported ADM use within the past 12 months. In high-income countries (HICs), depression (49.2%) and anxiety (36.4%) were the most common reasons for use. In low- and middle-income countries (LMICs), depression (38.4%) and sleep problems (31.9%) were the most common reasons for use. Prevalence of use was 2-4 times as high in HICs as LMICs across all examined diagnoses. Newer ADMs were proportionally used more often in HICs than LMICs. Across all conditions, ADMs were reported as very effective by 58.8% of users and somewhat effective by an additional 28.3% of users, with both proportions higher in LMICs than HICs. Neither ADM class nor reason for use was a significant predictor of perceived effectiveness. CONCLUSION: ADMs are in widespread use and for a variety of conditions including but going beyond depression and anxiety. In a general population sample from multiple LMICs and HICs, ADMs were widely perceived to be either very or somewhat effective by the people who use them.

Mixed methods implementation research to understand success of intensive combination approach to roll back the epidemic in Nigerian adolescents) (iCARE Nigeria) HIV testing uptake and linkage to care among young men focusing on young men who have sex with men in Ibadan.

BACKGROUND: HIV seroprevalence in Nigeria is increasing among men who have sex with men (MSM) from 14% to 2007 to 23% in 2014, threatening progress towards ending the epidemic in the country. Expanding access to HIV testing and linkage to care for key populations, like young MSM (YMSM), is critical to end the HIV epidemic in Nigeria. The Intensive Combination Approach to Roll Back the Epidemic in Nigerian Adolescents (iCARE Nigeria) pilot intervention successfully implemented a combination of evidence-based interventions utilizing peer navigators and popular social media apps and platforms to reach young men at risk for HIV exposure, including YMSM. We conducted sequential mixed methods explanatory implementation research to expand on the previously reported effectiveness and implementation outcomes and to explore the determinants and strategies which contributed to primary study results. METHODS: We conducted key informant interviews and focus group discussions with 2 peer navigators and 3 study staff at the end of the pilot. We used directed content analysis to understand the quantitative results from the pilot. Using the Implementation Research Logic Model, we were able to identify and map strategies through mechanisms of action from barriers addressed to the reported implementation outcomes including feasibility, acceptability fidelity and adoption. RESULTS: We found that iCARE Nigeria's pilot intervention implementers reported high feasibility, acceptability fidelity and adoption were associated with implementation of strategies which addressed many challenging contextual factors, including social stigma, online social networking, legal barriers surrounding MSM behavior, and the COVID-19 pandemic. These strategies included integration of stakeholders' interests, selection of experienced peer navigators including from the targeted population, training and supportive supervision using an implementation guide, ensuring safety (COVID and legal) and identification of clinics serving the targeted population. CONCLUSION: Mixed methods using implementation research frameworks provided insights into the strategies and barriers and facilitators they addressed which may explain the success of the pilot. These results can inform strategies needed to scale-up the intervention to youth including YMSM in other areas in Nigeria and the region. TRIAL REGISTRATION ISRCTN: ISRCTN94590823, https://doi.org/10.1186/ISRCTN94590823.

Psychological Distress Increases 30-Fold Among People with HIV in the First Year on ART in Nigeria-a Call for Integrated Mental Health Services.

BACKGROUND: Few studies have longitudinally assessed psychological distress among people with HIV (PWH) initiating ART in resource-limited settings. METHOD: Baseline, 6-month, and 12-month psychological distress were measured in a Nigerian cohort newly initiating therapy; the relationship between baseline factors and psychological distress at 12 months was assessed; and the association between psychological distress at 12 months and care retention or immunologic failure was determined. RESULTS: Among 563 patients, median age was 38 years (IQR: 33-46 years), 62% were female, and 51% were married. Psychological distress increased from 3% at baseline to 34% at 12 months. Age (aOR 1.28, 95% CI 1.06-1.56), female sex (aOR 2.89, 95% CI 1.93-4.33), lack of disclosure (aOR 4.32, 95% CI 2.48-7.51), and time on ART (6 months [aOR 6.91, 95% CI 3.14-15.18] and 12 months [aOR 32.63, 95% CI 16.54-64.36]) were associated with psychological distress while being married (OR 0.42, 95% CI 0.30-0.61) was associated with reduced odds. Tweve-month psychological distress was associated with increased risk of immunologic failure (aOR 2.22, 95% CI 1.31-3.82). CONCLUSION: The risk of psychological distress increased 30-fold in the first year on therapy in PWH in Nigeria.

Prevalence and correlates of depression among pregnant adolescents in primary maternal care in Nigeria.

To examine the prevalence as well as the clinical and psychosocial factors associated with depression and depression severity in pregnant adolescents. Participants were consecutively registered pregnant adolescents presenting to 30 selected primary maternal and child healthcare centers in Ibadan, Nigeria, who were screened for enrolment into an intervention trial for perinatal depression (depression defined as a score of ≥ 12 on the Edinburg Postnatal Depression Scale [EPDS] and met the DSM-IV diagnostic criteria for depression). Of the 1359 pregnant adolescents screened, 246 (18.1%) had depression. Mean age was 18.4 (sd 1.00), 58.9% were either married or cohabiting, 91.4% were primipara, and the mean gestational age was 23.8 weeks (sd 5.4 weeks). Food insecurity (going to bed hungry at least once in the previous week because there was no food to eat) was reported by 13.3%. In bivariate analysis, younger age, not living with a partner, unemployment, and food insecurity were associated with depression. In bivariate analysis, younger age, not living with a partner, unemployment and food insecurity were associated with depression, while younger age, being single and food insecurity were independently associated with being depressed in multivariate analysis. Severity of depression was related to age, higher anxiety and disability scores, lower quality of life scores across all domains and poorer attitudes towards pregnancy. Depression was associated with indices of higher social disadvantage among adolescents. Delaying childbearing and measures aimed at alleviating poverty may be important in preventing depression in this vulnerable group.

Theory-driven development of a mobile phone supported intervention for adolescents with perinatal depression.

PURPOSE: This paper describes the design of a theory-informed pragmatic intervention for adolescent perinatal depression in primary care in Nigeria. METHODS: We conducted Focus Group Discussions (FGDs) among 17 adolescent mothers and 25 maternal health care providers with experience in the receipt and provision of care for perinatal depression. The Consolidated Framework for Implementation Research (CFIR) was used to systematically examine the barriers and facilitators affecting adolescent mothers' use of an existing intervention package for depression. The Theoretical Domain Framework (TDF) and the Capability, Opportunity, Motivation, Behaviour (COM-B) model were used to analyze the results of the data across the five CFIR domains. RESULTS: FGD analysis revealed that care providers lacked knowledge on approaches to engage young mothers in treatment. Young mothers had poor treatment engagement, low social support, and little interest in parenting. A main characteristic of the newly designed intervention is the inclusion of age-appropriate psychoeducation supported with weekly mobile phone calls, to address treatment engagement and parenting behaviours of young mothers. Also in the outer setting, low social support from relatives was addressed with education, "as need arises" phone calls, and the involvement of "neighborhood mothers". In the inner settings, care providers' behaviour is addressed with training to increase their capacity to engage young mothers in treatment. CONCLUSION: A theory-based approach helped develop an age-appropriate intervention package targeting depression and parenting skills deficit among perinatal adolescents in primary maternal care and in which a pragmatic use of mobile phone was key.

Prevalence and correlates of sexual dysfunction among patients with mental disorders in a tertiary hospital in Southwest Nigeria.

BACKGROUND: Sexual dysfunction is more common among patients with mental disorders compared to the general population. Despite this high occurrence, information regarding sexual dysfunction as well as their correlates in patients receiving care for mental disorders in developing countries is still sparse. AIM: To determine the prevalence and correlates of sexual dysfunction among patients with mental disorders receiving care in a tertiary hospital in Southwest Nigeria. SETTING: This study was performed at the psychiatric outpatient clinic at the University College Hospital, Ibadan, Southwest Nigeria. METHODS: A cross-sectional study was conducted on a convenience sample of 238 adults aged 18-60 years. Socio-demographic and clinical information was obtained from all recruited patients. Sexual dysfunction was assessed using the International Index of Erectile Function questionnaire for men and the Female Sexual Function Index questionnaire for women. Questionnaires for measuring depression, medication adherence and autonomic medication side effects were also administered. Associations between sexual dysfunction and socio-demographic and clinical factors were explored. RESULTS: The prevalence rates of sexual dysfunction among male and female participants were 84.7% and 95.7%, respectively. In the multivariate analysis, employment status and autonomic side effects of psychotropic medications significantly predicted male sexual dysfunction, while religion and employment status were predictors of female sexual dysfunction. CONCLUSION: Sexual dysfunction is very common among patients with mental disorders, with higher rates in female participants. There is a need for clinicians to consider routine screening for sexual dysfunction in psychiatric outpatients with a view of providing psychosocial interventions to improve patient's quality of life.

Stigma and utilization of treatment for adolescent perinatal depression in Ibadan Nigeria.

BACKGROUND: Depression is a common and severe disorder among low-income adolescent mothers in low-and middle-income countries where resources for treatment are limited. We wished to identify factors influencing health service utilization for adolescent perinatal depression, in Nigeria to inform new strategies of care delivery. METHODS: Focus Group Discussions (FGDs) were conducted among purposively selected low-income young mothers (with medical histories of adolescent perinatal depression), and separately with primary care clinicians treating this condition in Ibadan, Nigeria. Participants from this community-based study were from the database of respondents who participated in a previous randomized control trial (RCT) conducted between 2014 and 2016 in 28 primary health care facilities in the 11 Local government areas in Ibadan. Semi-structured interview guides, framed by themes of the Behavioral Model for Vulnerable Populations, was developed to obtain views of participants on the factors that promote or hinder help-seeking and engagement (see additional files 1 & 2). FGDs were conducted, and saturation of themes was achieved after discussions with six groups. Transcripts were analyzed using content analysis. RESULTS: A total of 42 participants, 17 mothers (who were adolescents at the time of the RCT), and 25 care providers participated in 6 FGDs. The availability of care for perinatal depression at the primary care level was an important enabling factor in healthcare utilization for the adolescents. Perceived health benefits of treatment received for perinatal depression were strong motivation for service use. Significant stigma and negative stereotypes expressed by care providers towards adolescent pregnancy and perinatal depression were obstacles to care. However, individual patient resilience was a major enabling factor, facilitating service engagement. Providers trained in the management of perinatal depression were perceived to deliver more tolerant and supportive care that adolescent mothers valued. CONCLUSIONS: Participants identified unsupportive and stigmatizing clinic environments towards pregnant and parenting adolescents as significant barriers to accessing available care. Interventions to reduce stigma among healthcare providers may improve services for this vulnerable population.

Pre-marital predictors of marital violence in the WHO World Mental Health (WMH) Surveys.

PURPOSE: Intimate partner violence (IPV) is a pervasive public health problem. Existing research has focused on reports from victims and few studies have considered pre-marital factors. The main objective of this study was to identify pre-marital predictors of IPV in the current marriage using information obtained from husbands and wives. METHODS: Data from were obtained from married heterosexual couples in six countries. Potential predictors included demographic and relationship characteristics, adverse childhood experiences, dating violence, and psychiatric disorders. Reports of IPV and other characteristics from husbands and wives were considered independently and in relation to spousal reports. RESULTS: Overall, 14.4% of women were victims of IPV in the current marriage. Analyses identified ten significant variables including age at first marriage (husband), education, relative number of previous marriages (wife), history of one or more categories of childhood adversity (husband or wife), history of dating violence (husband or wife), early initiation of sexual intercourse (husband or wife), and four combinations of internalizing and externalizing disorders. The final model was moderately predictive of marital violence, with the 5% of women accounting for 18.6% of all cases of marital IPV. CONCLUSIONS: Results from this study advance understanding of pre-marital predictors of IPV within current marriages, including the importance of considering differences in the experiences of partners prior to marriage and may provide a foundation for more targeted primary prevention efforts.

Human Immunodeficiency Virus Type 1 and Tuberculosis Coinfection in Multinational, Resource-limited Settings: Increased Neurological Dysfunction.

BACKGROUND: AIDS Clinical Trial Group 5199 compared neurological and neuropsychological test performance of human immunodeficiency virus type 1 (HIV-1)-infected participants in resource-limited settings treated with 3 World Health Organization-recommended antiretroviral (ART) regimens. We investigated the impact of tuberculosis (TB) on neurological and neuropsychological outcomes. METHODS: Standardized neurological and neuropsychological examinations were administered every 24 weeks. Generalized estimating equation models assessed the association between TB and neurological/neuropsychological performance. RESULTS: Characteristics of the 860 participants at baseline were as follows: 53% female, 49% African; median age, 34 years; CD4 count, 173 cells/µL; and plasma HIV-1 RNA, 5.0 log copies/mL. At baseline, there were 36 cases of pulmonary, 9 cases of extrapulmonary, and 1 case of central nervous system (CNS) TB. Over the 192 weeks of follow-up, there were 55 observations of pulmonary TB in 52 persons, 26 observations of extrapulmonary TB in 25 persons, and 3 observations of CNS TB in 2 persons. Prevalence of TB decreased with ART initiation and follow-up. Those with TB coinfection had significantly poorer performance on grooved pegboard (P < .001) and fingertapping nondominant hand (P < .01). TB was associated with diffuse CNS disease (P < .05). Furthermore, those with TB had 9.27 times (P < .001) higher odds of reporting decreased quality of life, and had 8.02 times (P = .0005) higher odds of loss of productivity. CONCLUSIONS: TB coinfection was associated with poorer neuropsychological functioning, particularly the fine motor skills, and had a substantial impact on functional ability and quality of life. CLINICAL TRIALS REGISTRATION: NCT00096824.

High- versus low-intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: cluster randomised controlled trial (the EXPONATE trial).

BACKGROUND: Contextually appropriate interventions delivered by primary maternal care providers (PMCPs) might be effective in reducing the treatment gap for perinatal depression. AIM: To compare high-intensity treatment (HIT) with low-intensity treatment (LIT) for perinatal depression. METHOD: Cluster randomised clinical trial, conducted in Ibadan, Nigeria between 18 June 2013 and 11 December 2015 in 29 maternal care clinics allocated by computed-generated random sequence (15 HIT; 14 LIT). Interventions were delivered individually to antenatal women with DSM-IV (1994) major depression by trained PMCPs. LIT consisted of the basic psychosocial treatment specifications in the World Health Organization Mental Health Gap Action Programme - Intervention Guide. HIT comprised LIT plus eight weekly problem-solving therapy sessions with possible additional sessions determined by scores on the Edinburgh Postnatal Depression Scale (EPDS). The primary outcome was remission of depression at 6 months postpartum (EPDS < 6). RESULTS: There were 686 participants; 452 and 234 in HIT and LIT arms, respectively, with both groups similar at baseline. Follow-up assessments, completed on 85%, showed remission rates of 70% with HIT and 66% with LIT: risk difference 4% (95% CI -4.1%, 12.0%), adjusted odds ratio 1.12 (95% CI 0.73, 1.72). HIT was more effective for severe depression (odds ratio 2.29; 95% CI 1.01, 5.20; P = 0.047) and resulted in a higher rate of exclusive breastfeeding. Infant outcomes, cost-effectiveness and adverse events were similar. CONCLUSIONS: Except among severely depressed perinatal women, we found no strong evidence to recommend high-intensity in preference to low-intensity psychological intervention in routine primary maternal care. DECLARATION OF INTERESTS: None.

A survey of traditional and faith healers providing mental health care in three sub-Saharan African countries.

BACKGROUND: Traditional and faith healers constitute an important group of complementary and alternative mental health service providers (CAPs) in sub-Sahara Africa. Governments in the region commonly express a desire to integrate them into the public health system. The aim of the study was to describe the profile, practices and distribution of traditional and faith healers in three sub-Saharan African countries in great need for major improvements in their mental health systems namely Ghana, Kenya and Nigeria. MATERIALS AND METHODS: A mapping exercise of CAPs who provide mental health care was conducted in selected catchment areas in the three countries through a combination of desk review of existing registers, engagement activities with community leaders and a snowballing technique. Information was collected on the type of practice, the methods of diagnosis and the forms of treatment using a specially designed proforma. RESULTS: We identified 205 CAPs in Ghana, 406 in Kenya and 82 in Nigeria. Most (> 70%) of the CAPs treat both physical and mental illnesses. CAPs receive training through long years of apprenticeship. They use a combination of herbs, various forms of divination and rituals in the treatment of mental disorders. The use of physical restraints by CAPs to manage patients was relatively uncommon in Kenya (4%) compared to Nigeria (63.4%) and Ghana (21%). CAPs often have between 2- to 10-fold capacity for patient admission compared to conventional mental health facilities. The profile of CAPs in Kenya stands out from those of Ghana and Nigeria in many respects. CONCLUSION: CAPs are an important group of providers of mental health care in sub-Saharan Africa, but attempts to integrate them into the public health system must address the common use of harmful treatment practices.

Comparative case studies in integrated care implementation from across the globe: a quest for action.

BACKGROUND: Integrated care is the coordination of general and behavioral health and is a highly promising and practical approach to improving healthcare delivery and patient outcomes. While there is growing interest and investment in integrated care implementation internationally, there are no formal guidelines for integrated care implementation applicable to diverse healthcare systems. Furthermore, there is a complex interplay of factors at multiple levels of influence that are necessary for successful implementation of integrated care in health systems. METHODS: Guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework (Aarons et al., 2011), a multiple case study design was used to address two research objectives: 1) To highlight current integrated care implementation efforts through seven international case studies that target a range of healthcare systems, patient populations and implementation strategies and outcomes, and 2) To synthesize the shared and unique challenges and successes across studies using the EPIS framework. RESULTS: The seven reported case studies represent integrated care implementation efforts from five countries and continents (United States, United Kingdom, Vietnam, Israel, and Nigeria), target a range of clinical populations and care settings, and span all phases of the EPIS framework. Qualitative synthesis of these case studies illuminated common outer context, inner context, bridging and innovation factors that were key drivers of implementation. CONCLUSIONS: We propose an agenda that outlines priority goals and related strategies to advance integrated care implementation research. These goals relate to: 1) the role of funding at multiple levels of implementation, 2) meaningful collaboration with stakeholders across phases of implementation and 3) clear communication to stakeholders about integrated care implementation. TRIAL REGISTRATION: Not applicable.

Quality of perinatal depression care in primary care setting in Nigeria.

BACKGROUND: Even though integrating mental health into maternal and child health (MCH) is widely accepted as a means of closing the treatment gap for maternal mental health conditions in low- and middle-income countries (LMIC), there are not many studies on the quality of the currently available mental health care for mothers in these countries. This study assessed the existing organization of service for maternal mental health, the actual care delivered for perinatal depression, as well as the quality of the care received by affected women presenting to primary care clinics in Ibadan, Nigeria. METHODS: The Assessment of Chronic Illness Care (ACIC) tool was administered to the staff in 23 primary maternal care clinics and key informant interviews were conducted with 20 facility managers to explore organizational and administrative features relevant to the delivery of maternal mental health care in the facilities. Detection rate of perinatal depression by maternal care providers was assessed by determining the proportion of depressed antenatal women identified by the providers. The women were then followed up from the antenatal period up until 6 months after childbirth to track their experience with care received. RESULTS: All the facilities had ACIC domain scores indicating poor capacity to offer quality chronic care. Emerging themes from the interviews included severe manpower shortage and absence of administrative and clinical support for manpower training and care provision. Only 31 of the 218 depressed women had been identified by the maternal care providers as having a psychological problem throughout the follow-up period. In spite of the objective evidence of inadequate care, most of the perinatal women rated the service provided in the facilities as being of good quality (96%) and reported being satisfied with the care received (98%). CONCLUSION: There are major inadequacies in the organisational and administrative profile of these primary maternal care facilities that militate against the provision of quality chronic care. These inadequacies translate to a large treatment gap for women with perinatal depression. Lack of awareness by service users of what constitutes good quality care, indicative of low service expectation, may hamper user-driven demand for quality improvement.

Collaboration Between Biomedical and Complementary and Alternative Care Providers: Barriers and Pathways.

We examined the scope of collaborative care for persons with mental illness as implemented by traditional healers, faith healers, and biomedical care providers. We conducted semistructured focus group discussions in Ghana, Kenya, and Nigeria with traditional healers, faith healers, biomedical care providers, patients, and their caregivers. Transcribed data were thematically analyzed. A barrier to collaboration was distrust, influenced by factionalism, charlatanism, perceptions of superiority, limited roles, and responsibilities. Pathways to better collaboration were education, formal policy recognition and regulation, and acceptance of mutual responsibility. This study provides a novel cross-national insight into the perspectives of collaboration from four stakeholder groups. Collaboration was viewed as a means to reach their own goals, rooted in a deep sense of distrust and superiority. In the absence of openness, understanding, and respect for each other, efficient collaboration remains remote. The strongest foundation for mutual collaboration is a shared sense of responsibility for patient well-being.

Explanatory model of psychosis: impact on perception of self-stigma by patients in three sub-saharan African cities.

BACKGROUND: Most cultures in sub-Saharan Africa subscribe to the belief that the root cause of psychosis is supernatural. Individuals in the community who hold a religiomagical explanatory model of causation have been shown to exhibit more stigmatizing attitudes towards people with psychosis. Self-stigma among individuals with psychosis is less frequently studied. METHOD: We used a mixed-method approach, consisting of key informant's interviews to elicit information on explanatory models of causation of psychosis and questionnaire assessment of internalized stigma with an adapted version of the Scale for Internalized Stigma of Mental Illness. Twenty-four, 31, and 30 subjects with recent experience of utilizing the service of traditional or faith healers for severe mental disorders in Ibadan (Nigeria), Kumasi (Ghana), and Nairobi (Kenya), respectively, were interviewed. RESULTS: About 44 % (42.1 %) of the Nigerian respondents had a high (severe) level of self-stigma with the respective proportions among Ghanaian and Kenyan respondents being 20.7 and 37.5 %. Compared with 4 out of a total of 12 respondents (33.3 %) who reported low self-stigma reported supernatural attribution, 14 out of 20 respondents (70 %) with the highest level of self-stigma reported supernatural attribution across the three sites. When low scorers ascribed supernatural causation, it was often with a religious focus. CONCLUSION: There is a greater tendency for persons with high levels of self-stigma than those with low levels to ascribe supernatural attribution to their experience of a severe mental health condition.

A cluster randomized clinical trial of a stepped care intervention for depression in primary care (STEPCARE)--study protocol.

BACKGROUND: Depression constitutes a significant public health burden and is associated is with high level of individual suffering. Insufficient human and material resources impede the provision of adequate care for persons with the condition in low- and middle-income countries. It is commonly recognized that, to bridge this treatment gap, it is essential to integrate the treatment of depression into primary health care system. METHODS/DESIGN: STEPCARE is a two-arm parallel cluster randomized controlled trial to compare a stepped-care intervention package for depression in primary health care with care as usual in Nigeria. Randomization was conducted at the level of the participating primary health care clinics, while interventions are delivered to consenting individual participants who screen positive on the 9-item patient health questionnaire (PHQ-9 score ≥ 11) and fulfil the DSM-IV criteria for major depression. Intervention delivered by trained primary health care workers (PHCW) supported by general physicians and psychiatrists as needed is in 3 steps determined by response to treatment. Each step consists of psychological interventions (including psychoeducation, activity scheduling, social network reactivation and problem solving treatment) offered to all participants and, depending on severity and response, medication. Primary outcome, assessed at 12 months following recruitment into the trial, is recovery from depression as shown by a PHQ-9 score of less than 6. Secondary outcomes include changes in disability, quality of life and service utilization assessed at 6 and 12 months. DISCUSSION: The stepped care model examines the effectiveness of an intervention package for depression in which the intensity of treatment is determined by the clinical need of the patients. This approach is designed to make the most efficient use of available resources. TRIAL REGISTRATION: ISRCTN46754188 (ISRTCN registry at isrtcn.com; registered 23 September 2013).

Expanding care for perinatal women with depression (EXPONATE): study protocol for a randomized controlled trial of an intervention package for perinatal depression in primary care.

BACKGROUND: Depression is common among women during perinatal period and is associated with long-term adverse consequences for the mother and infant. In Nigeria, as in many other low- and-middle-income countries (LMIC), perinatal depression usually goes unrecognized and untreated. The aim of EXPONATE is to test the effectiveness and cost-effectiveness of an intervention package for perinatal depression delivered by community midwives in primary maternal care in which physician support and enhanced patient compliance are implemented using mobile phones. METHODS/STUDY DESIGN: A pragmatic two-arm parallel cluster randomized controlled trial was designed. The units of allocation are the primary maternal care clinics. Thirty eligible and consenting clinics were randomized but, due to problems with logistics, 29 eventually participated. Consenting pregnant women with a gestational age between 16 and 28 weeks who screened positive on the Edinburgh Postnatal Depression Scale (EPDS score ≥12), absent psychosis or bipolar disorder, and not actively suicidal were recruited into the trial (N = 686). Midwives in the intervention arm were trained to deliver psychoeducation, problem solving treatment, and parenting skills. Eight weekly sessions were delivered following entry into the study. Further sessions during pregnancy and 6 weeks following childbirth were determined by level of depressive symptoms. Clinical support and supervision, delivered mainly by mobile phone, were provided by general physicians and psychiatrists. Automated text and voice messages, also delivered by mobile phones, were used to facilitate patient compliance with clinic appointments and 'homework' tasks. Patients in the control arm received care as usual enhanced by further training of the providers in that arm in the recognition and standard treatment of depression. Assessments are undertaken at baseline, 2 months following recruitment into the study and 3, 6, 9 and 12 months after childbirth. The primary outcome is recovery from depression (EPDS < 6) at 6 months. Secondary outcomes include measures of disability, parenting skills, maternal attitudes, health care utilization as well as infant physical and cognitive development comprehensively assessed using the Bayley's Scales. DISCUSSION: To the best of our knowledge, this is the largest randomized controlled trial of an intervention package delivered by community midwives in sub-Saharan Africa. TRIAL REGISTRATION: Trial is registered with the ISRTCN registry at isrtcn.com; Trial number ISRCTN60041127 . Date of registration is 15/05/2013.

A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria.

BACKGROUND: Depression is common in primary care and is often unrecognized and untreated. Studies are needed to demonstrate the feasibility of implementing evidence-based depression care provided by primary health care workers (PHCWs) in sub-Saharan Africa. We carried out a pilot two-parallel arm cluster randomized controlled trial of a package of care for depression in primary care. METHODS: Six primary health care centers (PHCC) in two Local Government Areas of Oyo State, South West Nigeria were randomized into 3 intervention and 3 control clinics. Three PHCWs were selected for training from each of the participating clinics. The PHCWs from the intervention clinics were trained to deliver a manualized multicomponent stepped care intervention package for depression consisting of psychoeducation, activity scheduling, problem solving treatment and medication for severe depression. Providers from the control clinics delivered care as usual, enhanced by a refresher training on depression diagnosis and management. Outcome measures Patient's Health Questionnaire (PHQ-9), WHO quality of Life instrument (WHOQOL-Bref) and the WHO disability assessment schedule (WHODAS) were administered in the participants' home at baseline, 3 and 6 months. RESULTS: About 98% of the consecutive attendees to the clinics agreed to have the screening interview. Of those screened, 284 (22.7%) were positive (PHQ-9 score ≥ 8) and 234 gave consent for inclusion in the study: 165 from intervention and 69 from control clinics. The rates of eligible and consenting participants were similar in the control and intervention arms. In all 85.9% (92.8% in intervention and 83% in control) of the participants were successfully administered outcome assessments at 6 months. The PHCWs had little difficulty in delivering the intervention package. At 6 months follow up, depression symptoms had improved in 73.0% from the intervention arm compared to 51.6% control. Compared to the mean scores at baseline, there was improvement in the mean scores on all outcome measures in both arms at six months. CONCLUSION: The results provide support for the feasibility of conducting a fully-powered randomized study in this setting and suggest that the instruments used may have the potential to detect differences between the arms. TRIAL REGISTRATION NUMBER: ISRCTN46754188 (ISRTCN registry at isrtcn.com); registered 23 September 2013, details of the pilot study added 12/02/2015.