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

NCT04138368 | Unknown

• 1 other identifier: EMC-0057-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 3.To show the effects of dyadic treatment for PPD mothers and their children on the child's emotional and behavioral development.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (2)

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

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

  8 weeks of treatment

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

  Dyadic therapy will reduce behavioral and developmental problems

  18 monthes of life

Study Arms (2)

dyadic treatment

EXPERIMENTAL

Mothers and infants will be treated with dyadic psychotherapy focused on interactions, emphasizing eye contact, body language, empathy, and social reciprocity, using the principles of Interaction Guidance Therapy (Sameroff et al., 2004). Dyadic psychotherapy will be administered one time a week during the 8-week trial period, at the subject's home. Each session, approximately 90 minutes long, will include videotaping mother-infant interaction, watching the last session's interaction as a part of video-feedback technique, and discussing main issues in the mother-infant relationship. In addition, each session will begin and end with a- 5-minute episode of affectionate touch and gaze synchrony between the mother and her infant.

Behavioral: dyadic psychotherapeutic intervention

supportive treatment

ACTIVE COMPARATOR

mothers will receive psychoeducational knowledge regarding the infants' development. The treatment will be administered one time a week during the 8-week trial period, at the subjects' home.

Behavioral: supportive intervention

Interventions

dyadic psychotherapeutic intervention BEHAVIORAL

Mothers and infants will be treated with dyadic psychotherapy focused on interactions, emphasizing eye contact, body language, empathy, and social reciprocity, using the principles of Interaction Guidance Therapy (Sameroff et al., 2004). Dyadic psychotherapy will be administered one time a week during the 8-week trial period, at the subject's home. Each session, approximately 90 minutes long, will include videotaping mother-infant interaction, watching the last session's interaction as a part of video-feedback technique, and discussing main issues in the mother-infant relationship. In addition, each session will begin and end with a- 5-minute episode of affectionate touch and gaze synchrony between the mother and her infant.

dyadic treatment

supportive intervention BEHAVIORAL

Supportive therapy: mothers will receive psychoeducational knowledge regarding the infants' development. The treatment will be administered one time a week during the 8-week trial period, at the subjects' home.

supportive treatment

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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...)

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Ilanir shchori

Afula, Israel

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Ilanit Elbaz, P.HD

CONTACT

972-54-4923334; ilanit_el@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of child and Adolescent Outpatient Psychiatric Clinic

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 24, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)