Clinical trial NCT02323152: PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK
Official title: PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Depression
Keywords: women
high risk
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2014-12-23
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.
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).

Primary outcomes:
measure: Depression Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Depression Scale
timeFrame: 12 weeks
measure: Vulnerable personality
timeFrame: 6 weeks
measure: Vulnerable personality
timeFrame: 12 weeks
measure: Physical Activity Questionare
timeFrame: 6 weeks
measure: Physical Activity Questionare
timeFrame: 12 weeks
measure: Temperament Style
timeFrame: 6 weeks
measure: Temperament Style
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Araba
name: AMAIA.UGARTEUGARTE@osakidetza.net UGARTE UGARTE
role: PRINCIPAL_INVESTIGATOR
References:
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.