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Trial record 33 of 403 for:    postpartum depression

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

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ClinicalTrials.gov Identifier: NCT02323152
Recruitment Status : Unknown
Verified December 2014 by MARIA PURIFICACIÓN LOPEZ PEÑA, Basque Health Service.
Recruitment status was:  Enrolling by invitation
First Posted : December 23, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
MARIA PURIFICACIÓN LOPEZ PEÑA, Basque Health Service

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.


Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: psychoeducation Other: Standard care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK
Study Start Date : September 2012
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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).

  4. 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

  5. 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

  6. 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).

  7. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323152


Sponsors and Collaborators
Basque Health Service
Investigators
Principal Investigator: AMAIA.UGARTEUGARTE@osakidetza.net UGARTE UGARTE Hospital Universitario Araba

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MARIA PURIFICACIÓN LOPEZ PEÑA, Maria Purificación Lopez Peña, Basque Health Service
ClinicalTrials.gov Identifier: NCT02323152     History of Changes
Other Study ID Numbers: PROGEA
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by MARIA PURIFICACIÓN LOPEZ PEÑA, Basque Health Service:
women
high risk

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications