Efficacy of a Program for the Management of Depression in Pregnant Women in Primary Care in São Paulo, Brazil

Depression Clinical Trial

— PROGRAVIDA  

Official title:

Cluster Randomised Controlled Trial of a Primary-care Based Intervention to Improve Depressive Symptoms of Pregnant Women in Sao Paulo, Brazil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01719289
• Other study ID #: CNPq 575320/2008-7
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2012
• Last updated: October 31, 2012
• Start date: March 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2012
• Source: University of Sao Paulo General Hospital
• Contact: Paulo R Menezes, PhD
• Phone: +55 11 30617093
• Email: progravida[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Despite the high prevalence of depressive disorders in pregnancy and puerperium and the possible negative consequences of these frames for women, children and family, there are still very scarce evidence on the effectiveness of interventions of low cost and viable, that can be made available on the net of Primary Health Care in Brazil and other middle or low income countries.

The main objective of this study is to evaluate the effectiveness of a depression management program, simple and low cost, delivered by nurse assistants, in reducing symptoms of depression in pregnant women treated in primary care clinics that adopt the Family Health Strategy (FHS) in São Paulo, compared to routine care. We will also assess the cost-effectiveness of this intervention.

We are conducting a community cluster randomized trial with pregnant women with symptoms of depression, attending antenatal care in primary care clinics that adopt the FHS in São Paulo. Participating clinics (12) were randomly allocated to have their nurse assistants receiving training and supervision to perform a program for management of depression among pregnant women (experimental group) or to offer routine care (control group).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

Moderate to high suicidal risk (assessed with a standardised protocol),

• Ongoing psychiatric treatment,

• Not able to understand Portuguese.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• PROGRAVIDA
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.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo
Brazil	Faculdade de Medicina da Universidade de Sao Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9)	PHQ-9 score=<4 will be considered success	4 months after inclusion in the study	No
Secondary	PHQ-9	PHQ-9 score=<4 will be considered success	6 months after delivery	No
Secondary	General Quality of life (EQ-5D)	The instrument contains 2 parts: a descriptive part that evaluates five domains (mobility, self care, usual activity, discomfort / pain and anxiety / depression). In this section a person assesses the current health on a scale 1-3 (none, moderate and severe). The respondent also makes self-evaluation through visual scale grading their health from 0 (worst possible) to 100 (best possible).	4 months after inclusion and 6 months after delivery	No