FACULTY OF CLINICAL SCIENCES
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Item Effect of intervention delivered by lay maternal care providers to improve outcome and parenting skills among adolescents with perinatal depression in Nigeria (the RAPiD study): a cluster randomized controlled trial(Elsevier, 2022) Gureje, O.; Oladeji, B. D.; Kola, L.; Bello, T.; Ayinde, O.; Faregh, N.; Bennett, I.; Zelkowitz, P.Background: Perinatal depression is more common and is associated with greater negative consequences among adolescents than adults. Psychosocial interventions designed for adults may be inadequate at addressing the unique features of adolescent perinatal depression. Methods: In a two-arm parallel cluster randomized trial conducted in thirty primary maternal care clinics in Ibadan, Nigeria (15-intervention and 15-control) we compared age-appropriate intervention consisting of problem-solving therapy, behavioral activation, parenting skills training, and parenting support from a self- identified adult to care as usual. Pregnant adolescents (aged <20 years) at fetal gestational age16–36 weeks with moderate to severe depression were recruited. Primary outcomes were depression symptoms (Edinburgh Postnatal Depression Scale, EPDS) and parenting practices (Infant-Toddler version of the Home Inventory for Measurement of the Environment, HOME-IT) at six-months postnatal. Results: There were 242 participants (intervention arm: 141; Control arm: 101), with a mean age of 18∙0 (SD- 1∙2). Baseline mean EPDS score was 14∙2 (SD-2.1); 80∙1 % completed the six-month postnatal follow-up. The intervention group had lower level of depressive symptoms than the control group, mean EPDS scores: 5∙5 (SD- 3∙6) versus 7∙2 (SD-4∙0) (adjusted mean difference -1∙84 (95%CI- 3∙06 to 0∙62; p =0∙003) and better parenting practices, mean total HOME-IT scores: 29∙8 (SD-4∙4) versus 26∙4 (SD-4∙2) (adjusted mean difference 3∙4 (95%Cl- 2∙12 to 4∙69, p =0∙001). Limitations: This study explored the effect of complex interventions making it difficult to know precisely what aspects produced the outcomes. Conclusions: An age-appropriate psychosocial intervention package holds promise for scaling up care for adolescents with perinatal depression especially in resource-constrained settings.Item Prevalence and correlates of depression among pregnant adolescents in primary maternal care in Nigeria(Springer, 2022) Oladeji, B. D.; Bello, T.; Ayinde, O.; Idowu, P.; Gureje, O.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.Item High versus low intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: a cluster randomized controlled trial: (the EXPONATE trial)(2019) Gureje, O.; Oladeji, B. D.; Montgomery, A. A.; Araya, R.; Bello, T.; Chisholm, D.; Groleau, D.; Kirmayer, L. J.; Kola, L.; Olley, L.; Tan, W.; Zelkowitz, P.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 0% 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.Item A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria(2015) Oladeji, B. D.; Kola, L.; Abiona, T.; Montgomery, A. A.; Araya, R.; Gureje, O.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 1.6% 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.Item Collaborative shared care to improve psychosis outcome (COSIMPO): study protocol for a randomized controlled trial(BioMed Central, 2017) Gureje, O.; Makanjuola, V.; Kola, L.; Yusuf, B.; Price, L.; Esan, O.B.; Oladeji, B.D.; Appiah-Poku, J.; Haris, B.; Othieno, C.; Seedat, S.Keywords Background: Psychotic disorders are a group of severe mental disorders that cause considerable disability to sufferers and a high level of burden to families. In many low- and middle-income countries (LMIC), traditional and faith healers are the main providers of care to affected persons. Even though frequently canvassed as desirable for improved care delivery, collaboration between these complementary alternative health providers (CAPs) and conventional health providers has yet to be rigorously tested for feasibility and effectiveness on patient outcomes. Methods/design: COSIMPO is a single-blind, cluster randomized controlled trial (RCT) being conducted in Nigeria and Ghana to compare the effectiveness of a collaborative shared care (CSC) intervention program implemented by CAPs and primary health care providers (PHCPs) with care as usual (CAU) at improving the outcome of patients with psychosis. The study is designed to test the hypotheses that patients receiving CSC will have a better clinical outcome and experience fewer harmful treatment practices from the CAPs than patients receiving CAU at 6 months after study entry. An estimated sample of 296 participants will be recruited from across 51 clusters, with a cluster consisting of a primary care clinic and its neighboring CAP facilities. CSC is a manualized intervention package consisting of regular and scheduled visits of PHCPs to CAP facilities to assist with the management of trial participants. Assistance includes the administration of antipsychotic medications, management of comorbid physical condition, assisting the CAP to avoid harmful treatment practices, and engaging with CAPs, caregivers and participants in planning discharge and rehabilitation. The primary outcome, assessed at 6 months following trial entry, is improvement on the Positive and Negative Symptom Scale (PANSS). Secondary outcomes, assessed at 3 and 6 months, consist of levels of disability, experience of harmful treatment practices and of victimization, and levels of perceived stigma and of caregivers’ burden. Discussion: Information about whether collaboration between orthodox and complementary health providers is feasible and can lead to improved outcome for patients is important to formulating policies designed to formally engage the services of traditional and faith healers within the public health system.