Clinical trial NCT01719289: Efficacy of a Program for the Management of Depression in Pregnant Women in Primary Care in São Paulo, Brazil
Official title: Cluster Randomised Controlled Trial of a Primary-care Based Intervention to Improve Depressive Symptoms of Pregnant Women in Sao Paulo, Brazil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: depression
problem solving
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-11-01
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 4 months after inclusion in the study
Secondary outcomes:
measure: PHQ-9
timeFrame: 6 months after delivery
measure: General Quality of life (EQ-5D)
timeFrame: 4 months after inclusion and 6 months after delivery
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de Sao Paulo
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Paulo R Menezes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Marcia Scazufca, PhD
role: STUDY_DIRECTOR
References: