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Clinical Trials/NCT02323152
NCT02323152
Unknown
Not Applicable

PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK

Basque Health Service0 sites135 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Depression
Sponsor
Basque Health Service
Enrollment
135
Primary Endpoint
Depression Scale
Last Updated
11 years ago

Overview

Brief Summary

Postpartum depression is a disease with a prevalence of 10% which has not only deleterious consequences for the mother but also for the baby and can delay the physical, social and cognitive development of the baby. Therefore we consider very important to prevent this disease as from the centers of care for women with a multidisciplinary approach. The aim of this study is to determine whether psychoeducation oriented in problem solving is effective in preventing the development of postpartum depression in women with very high risk.

Methodology: screening of 1000 women in 3rd trimester of pregnancy. We expect that 25% have at least one risk factor for postpartum depression (250). Of these women, aproximately a 50% will have a very high risk of developing postpartum depressión and will be included in the study (n = 125). These women will be randomized to two groups: treatment with psychotherapy focused on problem solving (6 sessions: 1 individual session + 5 group sessions) or usual care control group (usual postpartum control).

After treatment, women will be evaluated twice, at the end of therapy and at 6 weeks. Survival curves will be used tu assess the time it takes patients to develop major depression in the postpartum.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
September 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Basque Health Service
Responsible Party
Principal Investigator
Principal Investigator

MARIA PURIFICACIÓN LOPEZ PEÑA

Maria Purificación Lopez Peña

Basque Health Service

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Depression Scale

Time Frame: 6 weeks

Participants' symptoms are assessed using the Edimburg scale (Cox et al., 1987) This 10 item self report measure is designed to screen women for symptoms of emotional distress during pregnancy and the postnatal period.This scale has been validated in Castilian Spanish 2012 (CARPETA)

Secondary Outcomes

  • Depression Scale(12 weeks)
  • Vulnerable personality(12 weeks)
  • Physical Activity Questionare(12 weeks)
  • Temperament Style(12 weeks)

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