A Brief Relationship-Based Intervention for Post-Partum Depression; Effects on Mother's Hormones, Depression and Parenting and on Infant Social-Emotional Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Behavioral Assessment of dialogue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Behavioral Assessment of dialogue
时间窗: 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
时间窗: 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
次要结局
- Hormonal Assays- Oxytocin(trail 2- after treatment- 2-3 months after trail 1)
- Behavioral Assessment of dialogue(trail 2- after treatment- 2-3 months after trail 1)
研究者
Moran Influs
Principal Investigator
Interdisciplinary Center Herzliya