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临床试验/NCT04138368
NCT04138368Unknown不适用

The Effect of Early Dyadic Psychotherapeutic Intervention for Mothers Suffering From PPD on Oxytocin Level and on Childrens' Emotional and Behavioral Development

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
the dyadic psychotherapy reinforce mother-child bonding and attachment, over and above the standard supportive care.

研究概览

简要总结

Background: Postpartum depression follows approximately 10-15% of deliveries. Maternal functional disability, particularly in the relationship with the infant, a hallmark of PPD, causes impairment in the mother's ability to bond with her infant. Subsequently, this impairment leads to deleterious long-term consequences for infant cognitive, neurological, and social-emotional growth, and is associated with psychiatric disorders in later life. Therefore, the development of effective short-term treatment in such a highly prevalent phenomenon is of a high clinical priority. While pharmacological and psychological treatments are effective in treating PPD , these interventions have failed to show a significant improvement in mother-child interaction quality and infant development.

The Oxytocin System: Oxytocin (OXT) is a nine amino acid neuro-peptide, found exclusively in mammals and is released during labor and lactation. Among the central influences of OXT on human social behavior are increased trust, empathy and eye contact. Brain imaging found that maternal attachment activates regions in the brain's reward systems that are rich with oxytocin and vasopressin receptors . Such findings led researchers to speculate that OXT may be involved in linking and maintaining the connection between social recognition systems and feelings of pleasure . According to this speculation, pair bonding is a form of conditioned reward learning, whereby OXT promotes the reward in social encounters, thus enhancing the motivation to engage in such interaction .

Disruptions to the oxytocin system in depression have been repeatedly observed, and woman suffering from PPD have lower plasma OXT concentrations in comparison to the control group . A recent small treatment study of OXT in women suffering from PPD did not show a positive effect on mood; however, it did show improved mother-child interactions.

Studies suggest a bio-behavioral feedback loop of OXT, parenting, and infant social competence. Rationale and Hypotheses of the Current Research: We speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development.

The aims of this study are:

  1. To assess the relationship between levels of oxytocin in mothers suffering from postpartum depression and their babies, before and after psychological dyadic treatment compered to supportive treatment.
  2. To study the added value of dyadic treatment over conventional supportive treatment for PPD that does not focus specifically on the mother's relationship with her baby.
  3. To show the effects of dyadic treatment for PPD mothers and their children on the child's emotional and behavioral development.

Methods: Subjects: 50 Mothers will be interviewed and diagnosed as suffering from PPD according to DSM-IV-TR, will be enrolled within 2-8 months postpartum.

详细描述

Background: Postpartum depression follows approximately 10-15% of deliveries. Maternal functional disability, particularly in the relationship with the infant, a hallmark of PPD, causes impairment in the mother's ability to bond with her infant. Subsequently, this impairment leads to deleterious long-term consequences for infant cognitive, neurological, and social-emotional growth, and is associated with psychiatric disorders in later life. Recently, biological correlates of maternal deprivation and maternal depression on the infant's brain in both animal and human studies have been found . Therefore, the development of effective short-term treatment in such a highly prevalent phenomenon is of a high clinical priority. While pharmacological and psychological treatments are effective in treating PPD, these interventions have failed to show a significant improvement in mother-child interaction quality and infant development.

The Oxytocin System: Oxytocin (OXT) is a nine amino acid neuro-peptide, found exclusively in mammals and is released during labor and lactation. The effects of OXT on the anterior cingulate, OFC and vmPFC, suggesting its effect on 'social brain' areas have been reported in the past , including modulation of maternal behaviors and paternal behaviors including positive affect, social gaze, touch, and vocal synchrony with the infant . Among the central influences of OXT on human social behavior are increased trust , empathy and eye contact . Brain imaging found that maternal attachment activates regions in the brain's reward systems that are rich with oxytocin and vasopressin receptors . Such findings led researchers to speculate that OXT may be involved in linking and maintaining the connection between social recognition systems and feelings of pleasure . According to this speculation, pair bonding is a form of conditioned reward learning, whereby OXT promotes the reward in social encounters, thus enhancing the motivation to engage in such interaction .

Disruptions to the oxytocin system in depression have been repeatedly observed, and woman suffering from PPD have lower plasma OXT concentrations in comparison to the control group . Recent studies investigated the therapeutic potential of OXT in psychopathologies involving impaired social functioning such as autism spectrum disorders where OXT was found to facilitate social information processing and retention of social information, in social anxiety disorder , and schizophrenia where OXT administration resulted in a significant improvement in several social cognition measures and symptom reduction. Furthermore, a recent small treatment study of OXT in women suffering from PPD did not show a positive effect on mood; however, it did show improved mother-child interactions.

Studies suggest a bio-behavioral feedback loop of OXT, parenting, and infant social competence. The mechanisms of cross-generation transmission in the OXT system have been observed in human parents and infants in the first months of the infant's life and showed that parent and child's OXT levels are highly correlated and higher parental OXT was associated with higher infant OXT. Studies in non-human primates have shown long-term consequences on the development of social competence and infant's ultimate parental skills.

Rationale and Hypotheses of the Current Research: We speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • women age 18 years old +
  • women screening score of Depression EPDS>10 (Edinburgh quastionnnaire)
  • single child delivery
  • babies 3-8 monthes years old

排除标准

  • severe MDD
  • intelectual disability
  • women screening score of Depression EPDS<10 (Edinburgh quastionnnaire)
  • pregnant women
  • women diagnosed with Bipolar disorder or Schizophrenia, delirium, psychosis *due to drug abuse, OCD
  • Aggressive intentions towards the baby
  • high risk for self and other injury
  • drug abuse
  • physical condition influencing depressive symptoms
  • unstable physical condition due to various illnesses (cancer, diabetes...)

结局指标

主要结局

the dyadic psychotherapy reinforce mother-child bonding and attachment, over and above the standard supportive care.

时间窗: 8 weeks of treatment

Oxytocin levels under dyadic therapy will be higher compared to the control group

the dyadic psychotherapy will prevent the development of emotional psychopathology of the child

时间窗: 18 monthes of life

Dyadic therapy will reduce behavioral and developmental problems

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guy Schusheim

Director of child and Adolescent Outpatient Psychiatric Clinic

HaEmek Medical Center, Israel

研究点 (1)

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