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| Tracking Information | |||||
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| First Received Date ICMJE | August 20, 2007 | ||||
| Last Updated Date | August 20, 2007 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
EPDS [ Time Frame: 3 and 6 months ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
four dimensions of the Short Form-36 (SF-36) Questionnaire: mental health; emotional role; social functioning; and vitality(34) and significant clinical improvement. [ Time Frame: 3 and 6 months ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile | ||||
| Official Title ICMJE | Randomized Clinical Trial for the Treatment of Postnatal Depression | ||||
| Brief Summary | A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development. |
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| Detailed Description | Background: We compared the effectiveness of a multi-component intervention with usual care to treat postnatal depression among low-income mothers in primary care clinics in Santiago, Chile. Methods: Randomised controlled trial. Two hundred and thirty mothers with major depression attending postnatal clinics were randomly allocated to either a multi-component intervention or usual care. The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed. Data were analysed on an intention-to-treat basis. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) at 3 and 6 months after randomisation. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Postnatal Depression | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | Rojas G, Fritsch R, Solis J, Jadresic E, Castillo C, González M, Guajardo V, Lewis G, Peters TJ, Araya R. Treatment of postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile: a randomised controlled trial. Lancet. 2007 Nov 10;370(9599):1629-37. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 230 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00518830 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 1040434 | ||||
| Study Sponsor ICMJE | Fondo Nacional de Desarrollo Científico y Tecnológico, Chile | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Fondo Nacional de Desarrollo Científico y Tecnológico, Chile | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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