PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK

NCT02323152 | Unknown

• 1 other identifier: PROGEA
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Depression Scale

  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)

  6 weeks

Secondary Outcomes (7)

• Depression Scale

  12 weeks

• Vulnerable personality

  6 weeks

• Vulnerable personality

  12 weeks

• Physical Activity Questionare

  6 weeks

• Physical Activity Questionare

  12 weeks

Study Arms (2)

psychoeducation

EXPERIMENTAL

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

Behavioral: psychoeducation

Control group

ACTIVE COMPARATOR

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.

Other: Standard care

Interventions

psychoeducation BEHAVIORAL

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

psychoeducation

Standard care 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

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signature of informed consent.
• 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).
• 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.

You may not qualify if:

• Mental Retardation.
• Severe mental disorder decompensation that prevents understanding of the objectives of the study.
• Submit language difficulties that impede verbal comprehension / reading-writing.
• 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).

Sponsors & Collaborators

• Basque Health Service: lead

Related Publications (1)

• 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.

  PMID: 28086766 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• AMAIA.UGARTEUGARTE@osakidetza.net UGARTE UGARTE

  Hospital Universitario Araba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maria Purificación Lopez Peña

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: September 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 23, 2014

Record last verified: 2014-12