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Completed

NCT Number: NCT00518830

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

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.

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Key information

Conditions

Postnatal Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-component intervention

Other

The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance

Usual Care

Other

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

Primary outcomes

  1. EPDS

    Time frame: 3 and 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Other Gov

Registry information

Official study title

Randomized Clinical Trial for the Treatment of Postnatal Depression

Acronym: DPP

Important dates

Study start
2004
Study completion
2006
First posted
Aug 21, 2007
Registry last updated
Aug 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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