FACULTY OF CLINICAL SCIENCES

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    Exploring differences between adolescents and adults with perinatal depression-data from the expanding care for perinatal women with depression trial in Nigeria
    (2019-10) Oladeji, B. D.; Bello, T.; Kola, L.; Araya, R.; Zelkowitz, P.; Gureje, O.
    Background: Depression is common among women in the perinatal period. Although pregnancy and motherhood among adolescents are global public health issues, little is known about how adolescents differ from adults in the occurrence and correlates of perinatal depression. Methods: Data were derived from a cluster randomized controlled trial of psychosocial interventions for perinatal depression in primary maternal care in Nigeria (the Expanding Care for Perinatal Women with Depression trial). Adolescents and adult participants recruited during pregnancy and followed up till 6-month postpartum were compared: proportions with depression [screening positive to depression on the Edinburgh Postnatal Depression Scale (score ≥ 12) and meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria using the short form of the Composite International Diagnostic Interview]; adjustment and attitude to pregnancy and motherhood (using the Maternal Adjustment and Maternal Attitudes scale); and parenting skills (measured on Infant–Toddler version of the Home Inventory for Measurement of the Environment). Infant and fetal growth were assessed by measures of weight and head circumference at birth and upper mid-upper arm circumference (MUAC) at 6 months. Results: Of 8,580 adults screened, 6.9% had major depression compared with 17.7% of 772 screened adolescents (p < 0.001). Adolescents had significantly poorer adjustment and attitudes to pregnancy, lower mean fetal gestational age at birth, and a smaller mean baby’s birth weight. At 6-month postpartum, there were no significant differences in the rates of remission from depression between adolescent and adult women (Edinburgh Postnatal Depression Scale score <6). Adolescent mothers continued to have poorer maternal attitudes and parenting skills indicated by significantly lower scores on the Infant–Toddler version of the Home Inventory for Measurement of the Environment responsivity and involvement subscales. Infants of adolescent mothers had a higher rate of undernutrition (defined as MUAC < 12.5 cm) compared with those of adult mothers: 14.8 and 6.3%, respectively (p = 0.008), with the mean MUAC remaining significantly lower for infants of adolescent mothers after adjusting for their lower birth weight (p = 0.04). Conclusion: Perinatal depression is more common and is associated with poorer maternal attitudes and parenting skills in adolescents compared with those in adults. Evidence from this exploratory study suggests that in improving outcomes in infants of adolescent mothers with perinatal depression, depression treatment may need to be supplemented with specific approaches to improve parenting skills.
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    Effect of a stepped-care intervention delivered by lay health workers on major depressive disorder among primary care patients in Nigeria (STEPCARE): a cluster randomised controlled trial
    (Elsevier Ltd., 2019) Gureje, O.; Oladeji, B. D.; Montgomery, A. A.; Bello, T.; Kola, L.; Ojagbemi, A.; Chisolm, D.; Araya, R.
    Background Little is known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. We aimed to compare a stepped-care intervention package for depression with usual care enhanced by use of the WHO Mental Health Gap Action Programme intervention guide (mhGAP-IG). Methods We did a cluster-randomised trial in primary care clinics in Ibadan, Nigeria. Eligible clinics were those with adequate staffing to provide various 24-h clinical services and with regular physician supervision. Clinics (clusters), anonymised and stratified by local government area, were randomly allocated (1:1) with a computer-generated random number sequence to one of two groups: an intervention group in which patients received a stepped-care intervention (eight sessions of individual problem-solving therapy, with an extra two to four sessions if needed) plus enhanced usual care, and a control group in which patients received enhanced usual care only. Patients from enrolled clinics could participate if they were aged 18 years or older, not pregnant, and had moderate to severe depression (scoring ≥11 on the nine-item patient health questionnaire [PHQ-9]). The primary outcome was the proportion of patients with remission of depression at 12 months (a score of ≤6 on the PHQ-9, with assessors masked to group allocation) in the intention-to-treat population. This trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN46754188) and is completed. Findings 35 of 97 clinics approached were eligible and agreed to participate, of which 18 were allocated to the intervention group and 17 to the control group. 1178 patients (631 [54%] in the intervention group and 547 [46%] in the control group) were recruited between Dec 2, 2013, and June 29, 2015, among whom 976 (83%) were female and baseline mean PHQ-9 score was 13·7 (SD 2·6). Of the 562 (89%) patients in the intervention group and 473 (86%) in the control group who completed 12-month follow-up, similar proportions in each group had remission of depression (425 [76%] in the intervention group vs 366 [77%] in the control group; adjusted odds ratio 1∙0 [95% CI 0·70–1·40]). At 12 months, 17 (3%) deaths, one (<1%) psychotic illness, and one (<1%) case of bipolar disorder in the intervention group, and 16 deaths (3%) and one (<1%) case of bipolar disorder in the control group were recorded. No adverse events were judged to be related to the study procedures. Interpretation For patients with moderate to severe depression receiving care from non-physician primary health-care workers in Nigeria, a stepped-care, problem-solving intervention combined with enhanced usual care is similarly effective to enhanced usual care alone. Enhancing usual care with mhGAP-IG might provide simple and affordable approach to scaling up depression care in sub-Saharan Africa.
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    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.
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    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.
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    Effect of collaborative care between traditional and faith healers and primary health-care workers on psychosis outcomes in Nigeria and Ghana (COSIMPO): a cluster randomised controlled trial
    (Elsevier Ltd, 2020) Gureje, O.; Appiah-Poku, J.; Bello, T.; Kola, L.; Araya, R.; Chisholm, D.; Esan, O.B.; Harris, B.; Makanjuola, V.; Othieno, C.; Price, L.
    Background: Traditional and faith healers (TFH) provide care to a large number of people with psychosis in many sub Saharan African countries but they practise outside the formal mental health system. We aimed to assess the effectiveness and cost-effectiveness of a collaborative shared care model for psychosis delivered by TFH and primary health-care providers (PHCW). Methods: In this cluster-randomised trial in Kumasi, Ghana and Ibadan, Nigeria, we randomly allocated clusters (a primary care clinic and neighbouring TFH facilities) 1:1, stratified by size and country, to an intervention group or enhanced care as usual. The intervention included a manualised collaborative shared care delivered by trained TFH and PHCW. Eligible participants were adults (aged ≥18 years) newly admitted to TFH facilities with active psychotic symptoms (positive and negative syndrome scale [PANSS] score ≥60). The primary outcome, by masked assessments at 6 months, was the difference in psychotic symptom improvement as measured with the PANSS in patients in follow-up at 3 and 6 months. Patients exposure to harmful treatment practices, such as shackling, were also assessed at 3 and 6 months. Care costs were assessed at baseline, 3-month and 6-month follow-up, and for the entire 6 months of follow-up. This trial was registered with the National Institutes of Health Clinical Trial registry, NCT02895269. Findings: Between Sept 1, 2016, and May 3, 2017, 51 clusters were randomly allocated (26 intervention, 25 control) with 307 patients enrolled (166 [54%] in the intervention group and 141 [46%] in the control group). 190 (62%) of participants were men. Baseline mean PANSS score was 107∙3 (SD 17∙5) for the intervention group and 108∙9 (18∙3) for the control group. 286 (93%) completed the 6-month follow-up at which the mean total PANSS score for intervention group was 53∙4 (19∙9) compared with 67∙6 (23∙3) for the control group (adjusted mean difference –15∙01 (95% CI –21∙17 to –8∙84; 0·0001). Harmful practices decreased from 94 (57%) of 166 patients at baseline to 13 (9%) of 152 at 6 months in the intervention group (–0∙48 [–0∙60 to –0∙37] (p<0.001) and from 59 (42%) of 141 patients to 13 (10%) of 134 in the control group (–0·33 [–0∙45 to –0∙21] (p<0.001) with no significant difference between the two groups. Greater reductions in overall care costs were seen in the intervention group than in the control group. At the 6-month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group). Five patients in the intervention group had mild extrapyramidal side effects. Interpretation: A collaborative shared care delivered by TFH and conventional health-care providers for people with psychosis was effective and cost-effective. The model of care offers the prospect of scaling up improved care to this vulnerable population in settings with low resources