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

Postnatal Depression Clinical Trial

— DPP  

Official title:

Randomized Clinical Trial for the Treatment of Postnatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518830
• Other study ID #: 1040434
• Status: Completed
• Phase: N/A
• First received: August 20, 2007
• Last updated: August 20, 2007
• Start date: March 2004
• Est. completion date: July 2006

Study information

• Verified date: July 2007
• Source: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

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
included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPDS		3 and 6 months
Secondary	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