Efficacy of a Program for the Management of Depression in Pregnant Women in Primary Care in São Paulo, Brazil
PROGRAVIDA
Cluster Randomised Controlled Trial of a Primary-care Based Intervention to Improve Depressive Symptoms of Pregnant Women in Sao Paulo, Brazil
1 other identifier
interventional
600
1 country
2
Brief Summary
Background: depression during pregnancy is an important problem for public health. It has direct consequences for the affected woman, her children and family, and is a strong predictor of post-partum depression. In developing countries depression during pregnancy is highly common, and usually unrecognized and untreated. Aim: to evaluate the effectiveness and cost-effectiveness of an intervention delivered by nurse assistants in the management of pregnant women with depression in primary care clinics that adopt the Family Health Strategy in Sao Paulo, Brazil. Method: PROGRAVIDA is a cluster randomized controlled trial with pregnant women with depression attending pre-natal care in 12 Primary Care Units with Family Health Program, covering an area of 400,000 inhabitants in Sao Paulo, Brazil. The intervention follows a stepped-care approach and is delivered by health professionals working at the primary care unit responsible by the care of the women. All women from the intervention group receive a program based on psycho-education and problem solving techniques, delivered by a nurse assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2 after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the beginning of the sessions. Women with severe depression are referred to the family doctor and are assessed for the need of antidepressant medication. The control group receives routine care. The primary outcome is remission of depressive symptoms 4-months after the inclusion in the study. Secondary outcomes include remission of depressive symptoms at 6 months after delivery. Women are also assessed for socioeconomic and household characteristics, social support and obstetric complications. The effectiveness and cost-effectiveness of the intervention will be assessed with intention-to-treat analysis, using the clinical outcome and the assessment of quality of life (EQ-5D) four months after inclusion in the trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Mar 2011
Typical duration for not_applicable depression
2 active sites
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, 2011
CompletedFirst Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedNovember 1, 2012
October 1, 2012
2.7 years
October 29, 2012
October 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Health Questionnaire (PHQ-9)
PHQ-9 score=\<4 will be considered success
4 months after inclusion in the study
Secondary Outcomes (2)
PHQ-9
6 months after delivery
General Quality of life (EQ-5D)
4 months after inclusion and 6 months after delivery
Study Arms (2)
PROGRAVIDA
EXPERIMENTALAll women in this arm receive a stepped-care program for depression based on psycho-education and problem solving techniques.
Treatment as usual
NO INTERVENTIONPrimary health care professionals in charge of prenatal care are notified by the research team about all women with depression receiving pre-natal care and included in the trial. Primary health care professionals decide how to treat these women without any interference from the research team.
Interventions
Women in the intervention group receive a program based on psycho-education and problem solving techniques, delivered by a nurse assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2 after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the beginning of the sessions. Women with severe depression are referred to the family doctor and are assessed for the need of antidepressant medication.
Eligibility Criteria
You may qualify if:
- Pregnant women attending antenatal care in selected primary care clinics with Family Health Programs, who score a PHQ-9\>=5 just after the first antenatal consultation or around the 20th week of pregnancy.
You may not qualify if:
- Moderate to high suicidal risk (assessed with a standardised protocol),
- Ongoing psychiatric treatment,
- Not able to understand Portuguese.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 01246-903, Brazil
Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 01246-903, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paulo R Menezes, PhD
University of Sao Paulo
- STUDY DIRECTOR
Marcia Scazufca, PhD
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2012
First Posted
November 1, 2012
Study Start
March 1, 2011
Primary Completion
November 1, 2013
Study Completion
September 1, 2014
Last Updated
November 1, 2012
Record last verified: 2012-10