Relationship-Based Intervention for Post-Partum Depression

A Brief Relationship-Based Intervention for Post-Partum Depression; Effects on Mother's Hormones, Depression and Parenting and on Infant Social-Emotional Development

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.

Study Overview

• Status: Recruiting
• Conditions: Post Partum Depression
• Intervention / Treatment: Other: Post-partum depression- Dyadic psychotherapy-; Other: Post-partum depression- Psycho-educational therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moran Influs, Phd; Phone Number: 972-545343400; Email: moran.influs@gmail.com
• Study Contact Backup: Name: Ruth Feldman, Phd; Phone Number: 972-544566353; Email: feldman.ruth@gmail.com

Study Locations

• Israel
  • Herzliya, Israel, 4610101
    • Recruiting
    • Interdisciplinary Center
    • Contact: Moran Influs, Phd; Phone Number: 972-5343400; Email: moran.influs@gmail.com
    • Principal Investigator: Moran Influs, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Post-partum depression- Dyadic psychotherapy-; Mothers and infants will be treated with dyadic psychotherapy focused on interactions, emphasizing eye contact, body language, empathy, and social reciprocity. 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. During the whole therapy-trial, the therapist will also use cognitive-behavioral approach to address the mother's perception of her infant and of herself as a mother.
Active Comparator: 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.	Other: Post-partum depression- Psycho-educational therapy; Mothers will receive a therapy in their homes for 8 weeks, 1.5 hours for each session by a therapist arriving at their home. Each session will address a different developmental aspects of the baby (feeding, movement, social-emotional development etc.). Therapist will ask the mother about her baby, will give information about developmental needs and expectations and will help mother to enrich child's development and deal will potential problems
No Intervention: Control- Healthy mothers and their babies; No intervention for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Assessment of dialogue	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.	trail 1-baseline
Hormonal Assays- Oxytocin	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	trail 1-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Assessment of dialogue	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.	trail 2- after treatment- 2-3 months after trail 1
Hormonal Assays- Oxytocin	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	trail 2- after treatment- 2-3 months after trail 1

Collaborators and Investigators

• Sponsor: Interdisciplinary Center Herzliya
• Investigators: Study Director: Moran Influs, Phd, Interdisciplinary Center Herzliya, Israel

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: oxytocin; Post-partum depression; dyadic psychotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: InterdisciplinaryCH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No