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The study's objective was to determine the effectiveness of a task-sharing psychological treatment for perinatal depression using non-specialist community health workers. A double-blind individual randomised controlled trial was conducted in two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town. Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS) were randomised into the intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls). The primary outcome was response on the Hamilton Depression Rating Scale (HDRS) at three months postpartum (minimum 40% score reduction from baseline) among participants who did not experience pregnancy or infant loss (modified intention-to-treat population) (registered on Clinical Trials: NCT01977326). Of 2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n = 200; intervention: n = 184). There were no significant differences in response on the HDRS at three months postpartum between the intervention and control arm. A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa. The findings give cause for reflection on the strategy of task-sharing in low-resource settings., Competing Interests: Declaration of competing interest None., (Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Perinatal depression is a major public health issue especially in low income settings in South Africa, where there is a shortage of mental health professionals. New psychological interventions delivered by non-specialists are needed to fill the treatment gap. This paper describes the process of developing a manual based task sharing counselling intervention for perinatal depression in Khayelitsha, Cape Town., Methods: Qualitative semi-structured interviews were conducted with 26 participants, including service providers and service users at a clinic in Khayelitsha in order to explore the feasibility, acceptability and content of a task sharing counselling intervention. The interviews were recorded, translated and transcribed. Themes were identified using the framework analysis approach and were coded and analysed using NVivo v10. After the semi-structured interviews, a workshop was conducted with mental health experts on evidence-based psychological interventions for depression, together with a document review of counselling manuals for community health workers in South Africa., Results: The findings indicate that a task sharing counselling intervention was acceptable and feasible for depressed women in Khayelitsha, under the following conditions: (1) respondents preferred a female counsellor and felt that clinic based individual sessions should be provided at least once a month by an experienced Xhosa speaking counsellor from the community; and (2) the content of a counselling intervention should include psycho-education on cognitive and behavioural effects of depression, how to cope with interpersonal problems, and financial stressors. Based on these conditions, the review of manuals and expert consultation, key components of the counselling intervention were identified as: psycho-education, problem solving, healthy thinking and behaviour activation. These were included in the final counselling manual., Conclusion: The development of task sharing counselling interventions for perinatal depression should be informed by the views and needs of local service users and service providers. The study illustrates the manner in which these views can be incorporated for the development of evidence-based psychological interventions, within a task sharing framework in low and middle-income countries.

Background: Maternal depression carries a major public health burden for mothers and their infants, yet there is a substantial treatment gap for this condition in low-resourced regions such as sub-Saharan Africa. To address this treatment gap, the strategy of "task sharing" has been proposed, involving the delivery of interventions by non-specialist health workers trained and supervised by specialists in routine healthcare delivery systems. Several psychological interventions have shown benefit in treating maternal depression, but few have been rigorously evaluated using a task sharing approach. The proposed trial will be the first randomised controlled trial (RCT) evaluating a task sharing model of delivering care for women with maternal depression in sub-Saharan Africa. The objective of this RCT is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa., Methods/design: The study is an individual-level two-arm RCT. A total of 420 depressed pregnant women will be recruited from two ante-natal clinics in a low-income township area of Cape Town, using the Edinburgh Postnatal Depression Scale to screen for depression; 210 women will be randomly allocated to each of the intervention and control arms. The intervention group will be given six sessions of basic counseling over a period of 3 to 4 months, provided by trained community health workers (CHW)s. The control group will receive three monthly phone calls from a CHW trained to conduct phone calls but not basic counseling. The primary outcome measure is the 17-Item Hamilton Depression Rating Scale (HDRS-17). The outcome measures will be applied at the baseline assessment, and at three follow-up points: 1 month before delivery, and 3 and 12 months after delivery. The primary analysis will be by intention-to-treat and secondary analyses will be on a per protocol population. The primary outcome measure will be analyzed using linear regression adjusting for baseline symptom severity measured using the HDRS-17., Discussion: The findings of this trial can provide policy makers with evidence regarding the effectiveness and cost-effectiveness of structured psychological interventions for maternal depression delivered by appropriately trained and supervised non-specialist CHWs in sub-Saharan Africa., Trial Registration: Clinical Trials (ClinicalTrials.gov): NCT01977326, registered on 24/10/2013; Pan African Clinical Trials Registry (http://www.pactr.org): PACTR201403000676264, registered on 11/10/2013.