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

NCT ID: NCT00518830

Last Updated: 2007-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Postnatal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PND-MCI

The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed

Group Type EXPERIMENTAL

multi-component intervention

Intervention Type OTHER

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

usual care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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

Interventions

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multi-component intervention

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

Intervention Type OTHER

Usual care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Graciela Rojas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

References

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Rojas G, Fritsch R, Solis J, Jadresic E, Castillo C, Gonzalez 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. doi: 10.1016/S0140-6736(07)61685-7.

Reference Type DERIVED
PMID: 17993363 (View on PubMed)

Other Identifiers

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1040434

Identifier Type: -

Identifier Source: org_study_id