Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile - Full Text View

Sponsor:	Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Information provided by:	Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
ClinicalTrials.gov Identifier:	NCT00518830

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:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Clinical Trial for the Treatment of Postnatal Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression Postpartum Depression

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
PND-MCI: Experimental 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
usual care: Active Comparator '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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	1040434
Study First Received:	August 20, 2007
Last Updated:	August 20, 2007
ClinicalTrials.gov Identifier:	NCT00518830 History of Changes
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:

Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum

Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 08, 2010