PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK

NCT ID: NCT02323152

Last Updated: 2014-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Postpartum Depression

Keywords

women; high risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

psychoeducation

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

Group Type: EXPERIMENTAL

psychoeducation

Intervention Type: BEHAVIORAL

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

Control group

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.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

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

Interventions

psychoeducation

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

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. General criteria for inclusion in the study:

1. Pregnant women in the 3rd quarter. In the case of inclusion of children in the study were notified each case their participation to the Department.

2. Signature of informed consent.

1. Submitted one or more risk factor for developing postpartum depression:

• Depressive or anxious pathology during pregnancy.
• Personal history of severe mental disorder (schizophrenia and other psychoses, bipolar disorder, depressive disorder).
• Family history of severe mental disorder.
• Concomitant medical diseases associated with depression (diabetes, heart disease, hypertension, obesity).
• Low or very low socioeconomic status.
• Lack of support for women (couples, family, friends or others).

2. Submit a score ≥7.5 in the EPDS questionnaire. According Vega-Dienstmainer (Vega-Diesnstmainer JM, 2002), there weren't women with lower score than 7.5 that had been diagnosed with DPP (sensitivity and positive predictive value of 100%). Therefore, we considered selecting those patients with higher score of 7.5 on the EPDS scale.

Exclusion Criteria

1. Mental Retardation.

2. Severe mental disorder decompensation that prevents understanding of the objectives of the study.

3. Submit language difficulties that impede verbal comprehension / reading-writing.

4. Submit a major depressive episode according to DSM-IV TR (depressive symptoms of sufficient intensity and longer duration than 2 weeks).

All participants will be informed that they will be randomized to on of the two study groups and will only be included if they give their informed consent to participate in the study. Women in both groups will be evaluated at baseline (pre-intervention) at 6 and 12 weeks (postinternveción).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

MARIA PURIFICACIÓN LOPEZ PEÑA

Maria Purificación Lopez Peña

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AMAIA.UGARTEUGARTE@osakidetza.net UGARTE UGARTE

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Araba

References

Ugarte AU, Lopez-Pena P, Vangeneberg CS, Royo JG, Ugarte MA, Compains MT, Medrano MP, Toyos NM, Lamo EA, Duenas MB, Gonzalez-Pinto A. Psychoeducational preventive treatment for women at risk of postpartum depression: study protocol for a randomized controlled trial, PROGEA. BMC Psychiatry. 2017 Jan 13;17(1):13. doi: 10.1186/s12888-016-1162-5.

Reference Type: DERIVED

PMID: 28086766 (View on PubMed)

Other Identifiers

PROGEA

Identifier Type: -

Identifier Source: org_study_id