PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK

Not Applicable

• Conditions: Postpartum Depression
• Interventions: Other: Standard care; Behavioral: psychoeducation

• Registration Number: NCT02323152
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2014-12
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-22
• Last Update Submitted: 2014-12-22
• Study First Posted: 2014-12-23
• Last Update Posted: 2014-12-23
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Depression Scale	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

Name	Time	Method
Depression Scale	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
Vulnerable personality	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).
Physical Activity Questionare	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
Temperament Style	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).