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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Sao Paulo General Hospital
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01719289
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Depression
Behavioral: PROGRAVIDA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cluster Randomised Controlled Trial of a Primary-care Based Intervention to Improve Depressive Symptoms of Pregnant Women in Sao Paulo, Brazil

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: 4 months after inclusion in the study ] [ Designated as safety issue: No ]
    PHQ-9 score=<4 will be considered success


Secondary Outcome Measures:
  • PHQ-9 [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
    PHQ-9 score=<4 will be considered success

  • General Quality of life (EQ-5D) [ Time Frame: 4 months after inclusion and 6 months after delivery ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 600
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROGRAVIDA
All women in this arm receive a stepped-care program for depression based on psycho-education and problem solving techniques.
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.
No Intervention: Treatment as usual
Primary 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.

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719289

Contacts
Contact: Paulo R Menezes, PhD +55 11 30617093 progravida@usp.br

Locations
Brazil
Faculdade de Medicina da Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 01246-903
Contact: Paulo R Menezes, PhD    551130617093    pmenezes@usp.br   
Principal Investigator: Paulo R Menezes, PhD         
Principal Investigator: Marcia Scazufca, PhD         
Faculdade de Medicina da Universidade de Sao Paulo Recruiting
São Paulo, Brazil, 01246-903
Contact: Paulo R Menezes, PhD    551130617093    pmenezes@usp.br   
Principal Investigator: Paulo R Menezes, PhD         
Sub-Investigator: Marcia Scazufca, PhD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Paulo R Menezes, PhD University of Sao Paulo
Study Director: Marcia Scazufca, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01719289     History of Changes
Other Study ID Numbers: CNPq 575320/2008-7
Study First Received: October 29, 2012
Last Updated: October 31, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
depression
problem solving

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014