Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile
DPP
Randomized Clinical Trial for the Treatment of Postnatal Depression
1 other identifier
interventional
230
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2004
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 21, 2007
CompletedAugust 21, 2007
July 1, 2007
August 20, 2007
August 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EPDS
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.
3 and 6 months
Study Arms (2)
PND-MCI
EXPERIMENTALThe multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed
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
Interventions
The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance
included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
Eligibility Criteria
You may qualify if:
- Mothers meeting criteria for current DSM-IV major depression were eligible.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 17993363DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Graciela Rojas, MD
University of Chile
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 21, 2007
Study Start
March 1, 2004
Study Completion
July 1, 2006
Last Updated
August 21, 2007
Record last verified: 2007-07