TY - JOUR
T1 - Task sharing of a psychological intervention for maternal depression in Khayelitsha, South Africa
T2 - Study protocol for a randomized controlled trial
AU - Lund, Crick
AU - Schneider, Marguerite
AU - Davies, Thandi
AU - Nyatsanza, Memory
AU - Honikman, Simone
AU - Bhana, Arvin
AU - Bass, Judith
AU - Bolton, Paul
AU - Dewey, Michael
AU - Joska, John
AU - Kagee, Ashraf
AU - Myer, Landon
AU - Petersen, Inge
AU - Prince, Martin
AU - Stein, Dan J.
AU - Thornicroft, Graham
AU - Tomlinson, Mark
AU - Alem, Atalay
AU - Susser, Ezra
N1 - Publisher Copyright:
© 2014 Lund et al.; licensee BioMed Central Ltd.
PY - 2014/11/21
Y1 - 2014/11/21
N2 - 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 (www.pactr.org): PACTR201403000676264, registered on 11/10/2013.
AB - 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 (www.pactr.org): PACTR201403000676264, registered on 11/10/2013.
KW - Community health workers
KW - Cost-effectiveness
KW - Counseling
KW - Hamilton depression rating scale
KW - Maternal depression
KW - Randomized controlled trial
KW - Task sharing
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U2 - 10.1186/1745-6215-15-457
DO - 10.1186/1745-6215-15-457
M3 - Article
C2 - 25416557
AN - SCOPUS:84928795910
SN - 1745-6215
VL - 15
JO - Trials
JF - Trials
IS - 1
M1 - 457
ER -