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PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK

NCT02323152 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2014-12-23

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

psychoeducation

Usual treatment + psychoteraphy focused on problem solving (6 sessions). The psychoeducational programme consists of 6 sessions of 60 minutes, one per week.

OTHER

Standard care

Puerperal control with their doctor. This group will also be interviewed with the same frecuency of the experimental group but will not receive a psichologycal treatment

Sponsors & Collaborators

  • Basque Health Service

    lead OTHER_GOV

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02323152 on ClinicalTrials.gov