PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK (PROGEA)

December 22, 2014 updated by: MARIA PURIFICACIÓN LOPEZ PEÑA, Basque Health Service

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

  2. Inclusion criteria for treatment group:

    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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: psychoeducation
Usual treatment + psychoteraphy focused on problem solving (6 sessions). The psychoeducational programme consists of 6 sessions of 60 minutes, one per week.
Behavioral: psychoeducation
Usual treatment + psychoteraphy focused on problem solving (6 sessions). The psychoeducational programme consists of 6 sessions of 60 minutes, one per week.
Active Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Scale
Time Frame: 12 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
12 weeks
Vulnerable personality
Time Frame: 6 weeks
The Vulnerable Personality Style Questionnaire (VPSQ) is a nine-item self-report scale developed to asses personality traits which increase the risk of postpartum depression(Gelabert et al., 2011).
6 weeks
Vulnerable personality
Time Frame: 12 weeks
The Vulnerable Personality Style Questionnaire (VPSQ) is a nine-item self-report scale developed to asses personality traits which increase the risk of postpartum depression(Gelabert et al., 2011).
12 weeks
Physical Activity Questionare
Time Frame: 6 weeks

IPAQ: The International Physical Activity Questionnaires (IPAQ) provides a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity. The long version we use provide more detailed information often required in research work or for evaluation purposes (Martinez-Gonzalez et al., 2005)

GPAC : The Global Physical Activity Questionnaire was developed by WHO for monitoring physical activity in countries. Collects information about participation in physical activity and sedentary behavior in three frames (or fields). These fields are:

  • activity at work
  • activity at displacement
  • leisure activity
6 weeks
Physical Activity Questionare
Time Frame: 12 weeks

IPAQ: The International Physical Activity Questionnaires (IPAQ) provides a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity. The long version we use provide more detailed information often required in research work or for evaluation purposes (Martinez-Gonzalez et al., 2005)

GPAC : The Global Physical Activity Questionnaire was developed by WHO for monitoring physical activity in countries. Collects information about participation in physical activity and sedentary behavior in three frames (or fields). These fields are:

  • activity at work
  • activity at displacement
  • leisure activity
12 weeks
Temperament Style
Time Frame: 6 weeks
Merrill-Palmer-Revised Scales of Development: We measure the babys temperament with the Merrill-Palmer-Revised Scales of Development. This escale evaluates five main areas of development: cognition, language, motor skills, adaptive behavior and self-care and socioemotional. Provides information on global development the child to assess the presence of possible delays in some areas (Roid et al., 2004).
6 weeks
Temperament Style
Time Frame: 12 weeks
Merrill-Palmer-Revised Scales of Development: We measure the babys temperament with the Merrill-Palmer-Revised Scales of Development. This escale evaluates five main areas of development: cognition, language, motor skills, adaptive behavior and self-care and socioemotional. Provides information on global development the child to assess the presence of possible delays in some areas (Roid et al., 2004).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Investigators

  • Principal Investigator: AMAIA.UGARTEUGARTE@osakidetza.net UGARTE UGARTE, Hospital Universitario Araba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROGEA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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