Relationship-Based Intervention for Post-Partum Depression
- Conditions
- Post Partum Depression
- Interventions
- Other: Post-partum depression- Psycho-educational therapyOther: Post-partum depression- Dyadic psychotherapy-
- Registration Number
- NCT04193462
- Lead Sponsor
- Interdisciplinary Center Herzliya
- Brief Summary
A short term dyadic psychotherapy intervention for mothers with Post-Partum depression and their babies in the first year of life was developed. The investigators believe that following dyadic intervention mothers will show improvement in depressive symptoms, the quality of the mother-child relationship will improve, and maternal and infant's oxytocin levels will rise.
- Detailed Description
Subjects: 60 Mothers will be interviewed and diagnosed as suffering from Post-Partum- depression (PPD) according to the Diagnostic and Statistical Manual of Mental Disorders, IV version (DSM-IV), enrolling within 3-8 months postpartum. Mothers will be recruited through social media networks. Additional 40 mothers, 3-8 months postpartum will be assessed and diagnosed as not suffering from PPD or any other psychiatric psychopathology.
Procedure: The baseline assessment will be conducted at the infant's home. A parent-infant interaction will be videotaped and salivary oxytocin samples will be collected from the infant and from the mother.
The women in the PPD group will participate in 8 weeks of dyadic psychotherapy (DP) combining video feedback, or a psycho-educational treatment regarding child development (randomize selection will be made). During the 8-week treatment, salivary oxytocin samples will be collected from the infants and from the mother at the beginning and the end of each session.
Another assessment will be conducted at the infant's home, at the end of the treatment. As in the baseline condition, this assessment will include videotaped parent-infant interaction, as well as salivary oxytocin samples collection from the mother and from the infant. Parent-infant interaction will be filmed and assessed using the CIB Manual (Feldman, 1998) and the synchrony coding system.
Healthy mothers will undergo the same baseline assessment and a second assessment within 2-3 months, and won't get any treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- women diagnosed with Post-Partum depression, major or minor, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th version (DSM-5)
- 3-8 months after birth of one baby
- Mothers of twins
- Mothers of premature babies
- Comorbidity of psychopathology, women who have severe personality disorder or other psychiatric diagnose, besides depression or anxiety
- Women or babies who suffer from severe medical condition, such as developmental problems for the baby or disability.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Post-partum depression- Psycho-educational therapy Post-partum depression- Psycho-educational therapy 8 weeks of supportive therapy for the mother at her house, involving the baby. Each session will include different aspects of psycho-education regarding development of the baby. Post-partum depression- Dyadic psychotherapy Post-partum depression- Dyadic psychotherapy- Mothers and infants will be treated with 8 weeks dyadic psychotherapy at their home using video-feedback of mother-infant interaction to discuss main issues in the mother-infant relationship.
- Primary Outcome Measures
Name Time Method Behavioral Assessment of dialogue trail 1-baseline Interactions will be coded with the "Coding Interactive Behavior" (CIB) manual (Feldman, 1998), infant version. This version is composed of 37 codes rated on a scale of 1 to 5, as higher score means a better outcome.
Hormonal Assays- Oxytocin trail 1-baseline Three saliva samples will be collected using Salivettes® at baseline, following interaction, and 20 minutes after end and averaged. All samples will be then stored at -20°C. Salivette will be treated as following: centrifuged twice, at 4°C at 1500 x g for 30 minutes, aliquoted and lyophilized over few days- to concentrate by 4 times. The dry samples will be reconstructed in the assay buffer immediately before analysis using an oxytocin enzyme immunoassay commercial kit (ENZO, NY). The assay preformed according the kit's instruction. The concentration of oxytocin will be calculated using MatLab-7
- Secondary Outcome Measures
Name Time Method Hormonal Assays- Oxytocin trail 2- after treatment- 2-3 months after trail 1 Three saliva samples will be collected using Salivettes® at baseline, following interaction, and 20 minutes after end and averaged. All samples will be then stored at -20°C. Salivette will be treated as following: centrifuged twice, at 4°C at 1500 x g for 30 minutes, aliquoted and lyophilized over few days- to concentrate by 4 times. The dry samples will be reconstructed in the assay buffer immediately before analysis using an oxytocin enzyme immunoassay commercial kit (ENZO, NY). The assay preformed according the kit's instruction. The concentration of oxytocin will be calculated using MatLab-7
Behavioral Assessment of dialogue trail 2- after treatment- 2-3 months after trail 1 Interactions will be coded with the "Coding Interactive Behavior" (CIB) manual (Feldman, 1998), infant version. This version is composed of 37 codes rated on a scale of 1 to 5, as higher score means a better outcome.
Trial Locations
- Locations (1)
Interdisciplinary Center
🇮🇱Herzliya, Israel