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Relationship-Based Intervention for Post-Partum Depression

Primary Purpose

Post Partum Depression

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Post-partum depression- Dyadic psychotherapy-
Post-partum depression- Psycho-educational therapy
Sponsored by
Interdisciplinary Center Herzliya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Depression focused on measuring Post-partum depression, dyadic psychotherapy, oxytocin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Interdisciplinary CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Post-partum depression- Dyadic psychotherapy

Post-partum depression- Psycho-educational therapy

Control- Healthy mothers and their babies

Arm Description

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.

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.

No intervention for 8 weeks.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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

Full Information

First Posted
November 1, 2019
Last Updated
May 3, 2022
Sponsor
Interdisciplinary Center Herzliya
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1. Study Identification

Unique Protocol Identification Number
NCT04193462
Brief Title
Relationship-Based Intervention for Post-Partum Depression
Official Title
A Brief Relationship-Based Intervention for Post-Partum Depression; Effects on Mother's Hormones, Depression and Parenting and on Infant Social-Emotional Development
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Interdisciplinary Center Herzliya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression
Keywords
Post-partum depression, dyadic psychotherapy, oxytocin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-partum depression- Dyadic psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Post-partum depression- Psycho-educational therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control- Healthy mothers and their babies
Arm Type
No Intervention
Arm Description
No intervention for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Post-partum depression- Dyadic psychotherapy-
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Post-partum depression- Psycho-educational therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Behavioral Assessment of dialogue
Description
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.
Time Frame
trail 1-baseline
Title
Hormonal Assays- Oxytocin
Description
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
Time Frame
trail 1-baseline
Secondary Outcome Measure Information:
Title
Behavioral Assessment of dialogue
Description
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.
Time Frame
trail 2- after treatment- 2-3 months after trail 1
Title
Hormonal Assays- Oxytocin
Description
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
Time Frame
trail 2- after treatment- 2-3 months after trail 1

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moran Influs, Phd
Phone
972-545343400
Email
moran.influs@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Feldman, Phd
Phone
972-544566353
Email
feldman.ruth@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moran Influs, Phd
Organizational Affiliation
Interdisciplinary Center Herzliya, Israel
Official's Role
Study Director
Facility Information:
Facility Name
Interdisciplinary Center
City
Herzliya
ZIP/Postal Code
4610101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moran Influs, Phd
Phone
972-5343400
Email
moran.influs@gmail.com
First Name & Middle Initial & Last Name & Degree
Moran Influs, Phd

12. IPD Sharing Statement

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Relationship-Based Intervention for Post-Partum Depression

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