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

Study Overview
=================
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.

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.

Official Title
-----------------
Randomized Clinical Trial for the Treatment of Postnatal Depression

Conditions
-----------------
Postnatal Depression

Intervention / Treatment
-----------------
* Other: multi-component intervention
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PND-MCI<br>The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed | Other: multi-component intervention<br>* The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance<br>|
| Active Comparator: usual care<br>'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment | Other: Usual care<br>* included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPDS |  | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postnatal depression, primary care, depressed women