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

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ClinicalTrials.gov Identifier: NCT00518830
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : August 21, 2007
Sponsor:
Information provided by:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

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.

Condition or disease Intervention/treatment Phase
Postnatal Depression Other: multi-component intervention Other: Usual care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial for the Treatment of Postnatal Depression
Study Start Date : March 2004
Actual Study Completion Date : July 2006

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: PND-MCI
The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed
Other: multi-component intervention
The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance
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
Other: Usual care
included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment



Primary Outcome Measures :
  1. EPDS [ Time Frame: 3 and 6 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518830


Sponsors and Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Investigators
Principal Investigator: Graciela Rojas, MD University of Chile

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00518830     History of Changes
Other Study ID Numbers: 1040434
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: August 21, 2007
Last Verified: July 2007

Keywords provided by Fondo Nacional de Desarrollo Científico y Tecnológico, Chile:
postnatal depression
primary care
depressed women

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications