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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:
Information provided by:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
ClinicalTrials.gov Identifier:
NCT00518830
First received: August 20, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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 Intervention
Postnatal Depression
 Other: multi-component intervention
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial for the Treatment of Postnatal Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fondo Nacional de Desarrollo Científico y Tecnológico, Chile:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 230
Study Start Date: March 2004
Study Completion Date: July 2006
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518830

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

No publications provided by Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00518830     History of Changes
Other Study ID Numbers: 1040434
Study First Received: August 20, 2007
Last Updated: August 20, 2007
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

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
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013