title: Task sharing of a psychological intervention for maternal depression in Khayelitsha, South Africa: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, 46 Sawkins Road, Rondebosch, Cape Town, South Africa. crick.lund@uct.ac.za.
authors.forename: Crick
authors.initials: C
authors.lastname: Lund
authors.forename: Marguerite
authors.initials: M
authors.lastname: Schneider
authors.forename: Thandi
authors.initials: T
authors.lastname: Davies
authors.forename: Memory
authors.initials: M
authors.lastname: Nyatsanza
authors.forename: Simone
authors.initials: S
authors.lastname: Honikman
authors.forename: Arvin
authors.initials: A
authors.lastname: Bhana
authors.forename: Judith
authors.initials: J
authors.lastname: Bass
authors.forename: Paul
authors.initials: P
authors.lastname: Bolton
authors.forename: Michael
authors.initials: M
authors.lastname: Dewey
authors.forename: John
authors.initials: J
authors.lastname: Joska
authors.forename: Ashraf
authors.initials: A
authors.lastname: Kagee
authors.forename: Landon
authors.initials: L
authors.lastname: Myer
authors.forename: Inge
authors.initials: I
authors.lastname: Petersen
authors.forename: Martin
authors.initials: M
authors.lastname: Prince
authors.forename: Dan J
authors.initials: DJ
authors.lastname: Stein
authors.forename: Graham
authors.initials: G
authors.lastname: Thornicroft
authors.forename: Mark
authors.initials: M
authors.lastname: Tomlinson
authors.forename: Atalay
authors.initials: A
authors.lastname: Alem
authors.forename: Ezra
authors.initials: E
authors.lastname: Susser
mesh_terms: D002985:Clinical Protocols; D003153:Community Health Services; D003150:Community Health Workers / Q000193:education; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics / Q000193:education; D003863:Depression / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007318:Inservice Training; D057194:Intention to Treat Analysis; D016014:Linear Models; D008605:Mental Health Services; D009035:Mothers / Q000523:psychology*; D010348:Patient Care Team; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012720:Severity of Illness Index; D012947:Social Work; D013019:South Africa; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D000078329:Workforce