71931
document
Expanding care for perinatal women with depression ( EXPONATE ) : study protocol for a randomized controlled trial of an intervention package for perinatal depression in primary care . BACKGROUND Depression is common among women during perinatal period and is associated with long-term adverse consequences for the mother and infant . In Nigeria , as in many other low- and-middle-income countries ( LMIC ) , perinatal depression usually goes unrecognized and untreated . The aim of EXPONATE is to test the effectiveness and cost-effectiveness of an intervention package for perinatal depression delivered by community midwives in primary maternal care in which physician support and enhanced patient compliance are implemented using mobile phones . METHODS/STUDY DESIGN A pragmatic two-arm parallel cluster randomized controlled trial was designed . The units of allocation are the primary maternal care clinics . Thirty eligible and consenting clinics were randomized but , due to problems with logistics , 29 eventually participated . Consenting pregnant women with a gestational age between 16 and 28 weeks who screened positive on the Edinburgh Postnatal Depression Scale ( EPDS score ≥12 ) , absent psychosis or bipolar disorder , and not actively suicidal were recruited into the trial ( N = 686 ) . Midwives in the intervention arm were trained to deliver psychoeducation , problem solving treatment , and parenting skills . Eight weekly sessions were delivered following entry into the study . Further sessions during pregnancy and 6 weeks following childbirth were determined by level of depressive symptoms . Clinical support and supervision , delivered mainly by mobile phone , were provided by general physicians and psychiatrists . Automated text and voice messages , also delivered by mobile phones , were used to facilitate patient compliance with clinic appointments and 'homework ' tasks . Patients in the control arm received care as usual enhanced by further training of the providers in that arm in the recognition and standard treatment of depression . Assessments are undertaken at baseline , 2 months following recruitment into the study and 3 , 6 , 9 and 12 months after childbirth . The primary outcome is recovery from depression ( EPDS < 6 ) at 6 months . Secondary outcomes include measures of disability , parenting skills , maternal attitudes , health care utilization as well as infant physical and cognitive development comprehensively assessed using the Bayley 's Scales . DISCUSSION To the best of our knowledge , this is the largest randomized controlled trial of an intervention package delivered by community midwives in sub-Saharan Africa . TRIAL REGISTRATION Trial is registered with the ISRTCN registry at isrtcn.com ; Trial number ISRCTN60041127 . Date of registration is 15/05/2013 .
71932
Intervention_Educational
intervention package for perinatal depression
71933
Outcome_Mental
depression
71934
Outcome_Mental
perinatal depression
71935
Outcome_Mental
Depression
71936
Outcome_Mental
perinatal depression
71937
Outcome_Mental
perinatal depression
71938
Outcome_Physical
absent psychosis or bipolar disorder
71939
Outcome_Mental
depressive symptoms
71940
Outcome_Mental
recovery from depression
71941
Outcome_Physical
measures of
71942
Outcome_Mental
disability
71943
Outcome_Mental
parenting skills
71944
Outcome_Mental
maternal attitudes
71945
Outcome_Physical
health care utilization
71946
Outcome_Physical
infant physical and cognitive development
71947
Outcome_Physical
the Bayley 's Scales