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

Not Applicable

Completed

• Conditions: Postnatal Depression
• Interventions: Other: multi-component intervention; Other: Usual care

• Registration Number: NCT00518830
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-03
• Study Completion: 2006-07
• Status Verified: 2007-07
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-20
• Last Update Submitted: 2007-08-20
• Study First Posted: 2007-08-21
• Last Update Posted: 2007-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PND-MCI	multi-component intervention	The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed
usual care	Usual care	'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment

Primary Outcome Measures

Name	Time	Method
EPDS	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
four dimensions of the Short Form-36 (SF-36) Questionnaire: mental health; emotional role; social functioning; and vitality(34) and significant clinical improvement.	3 and 6 months