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

Primary Purpose

Postpartum Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
psychoeducation
Standard care
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring women, high risk

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    psychoeducation

    Control group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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
    Vulnerable personality
    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).
    Vulnerable personality
    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).
    Physical Activity Questionare
    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
    Physical Activity Questionare
    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
    Temperament Style
    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).
    Temperament Style
    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).

    Full Information

    First Posted
    December 18, 2014
    Last Updated
    December 22, 2014
    Sponsor
    Basque Health Service
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02323152
    Brief Title
    PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK
    Acronym
    PROGEA
    Official Title
    PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Basque Health Service

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Depression
    Keywords
    women, high risk

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    135 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    psychoeducation
    Arm Type
    Experimental
    Arm Description
    Usual treatment + psychoteraphy focused on problem solving (6 sessions). The psychoeducational programme consists of 6 sessions of 60 minutes, one per week.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    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
    Behavioral
    Intervention Name(s)
    psychoeducation
    Intervention Description
    Usual treatment + psychoteraphy focused on problem solving (6 sessions). The psychoeducational programme consists of 6 sessions of 60 minutes, one per week.
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Depression Scale
    Description
    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)
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Depression Scale
    Description
    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
    Time Frame
    12 weeks
    Title
    Vulnerable personality
    Description
    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).
    Time Frame
    6 weeks
    Title
    Vulnerable personality
    Description
    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).
    Time Frame
    12 weeks
    Title
    Physical Activity Questionare
    Description
    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
    Time Frame
    6 weeks
    Title
    Physical Activity Questionare
    Description
    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
    Time Frame
    12 weeks
    Title
    Temperament Style
    Description
    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).
    Time Frame
    6 weeks
    Title
    Temperament Style
    Description
    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).
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria General criteria for inclusion in the study: 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. Signature of informed consent. Inclusion criteria for treatment group: 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. Exclusion criteria 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AMAIA.UGARTEUGARTE@osakidetza.net UGARTE UGARTE
    Organizational Affiliation
    Hospital Universitario Araba
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28086766
    Citation
    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.
    Results Reference
    derived

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    PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK

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