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Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile (DPP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518830
First Posted: August 21, 2007
Last Update Posted: August 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
August 20, 2007
August 21, 2007
August 21, 2007
March 2004
Not Provided
EPDS [ Time Frame: 3 and 6 months ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile
Randomized Clinical Trial for the Treatment of Postnatal Depression
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Postnatal Depression
  • Other: multi-component intervention
    The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance
  • Other: Usual care
    included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
  • Experimental: PND-MCI
    The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed
    Intervention: Other: multi-component intervention
  • Active Comparator: usual care
    'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
    Intervention: Other: Usual care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
July 2006
Not Provided

Inclusion Criteria:

  • Mothers meeting criteria for current DSM-IV major depression were eligible.

Exclusion Criteria:

  • who had received any form of treatment for their depression during their current postnatal period,
  • those who were pregnant,
  • with psychotic symptoms,
  • serious suicidal risk,
  • history of mania,
  • alcohol or drug abuse
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00518830
1040434
No
Not Provided
Not Provided
Not Provided
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Not Provided
Principal Investigator: Graciela Rojas, MD University of Chile
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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