- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00518830
Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile (DPP)
Randomized Clinical Trial for the Treatment of Postnatal Depression
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PND-MCI
The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed
|
The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance
|
Active Comparator: usual care
'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
|
included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
EPDS
Time Frame: 3 and 6 months
|
3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 and 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Graciela Rojas, MD, University of Chile
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1040434
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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