Task sharing of a psychological intervention for maternal depression in Khayelitsha, South Africa: study protocol for a randomized controlled trial

Crick Lund, Marguerite Schneider, Thandi Davies, Memory Nyatsanza, Simone Honikman, Arvin Bhana, Judith Bass, Paul Bolton, Michael Dewey, John Joska, Ashraf Kagee, Landon Myer, Inge Petersen, Martin Prince, Dan J. Stein, Graham Thornicroft, Mark Tomlinson, Atalay Alem, Ezra Susser

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)457
Number of pages1
JournalTrials
Volume15
DOIs
StatePublished - 2014
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

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    Lund, C., Schneider, M., Davies, T., Nyatsanza, M., Honikman, S., Bhana, A., Bass, J., Bolton, P., Dewey, M., Joska, J., Kagee, A., Myer, L., Petersen, I., Prince, M., Stein, D. J., Thornicroft, G., Tomlinson, M., Alem, A., & Susser, E. (2014). Task sharing of a psychological intervention for maternal depression in Khayelitsha, South Africa: study protocol for a randomized controlled trial. Trials, 15, 457. https://doi.org/10.1186/1745-6215-15-457