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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2019
CompletedFirst Submitted
Initial submission to the registry
November 1, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMay 29, 2024
May 1, 2024
5.4 years
November 1, 2019
May 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Behavioral Assessment of dialogue
trail 2- after treatment- 2-3 months after trail 1
Hormonal Assays- Oxytocin
trail 2- after treatment- 2-3 months after trail 1
Study Arms (3)
Post-partum depression- Dyadic psychotherapy
EXPERIMENTALMothers 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.
Post-partum depression- Psycho-educational therapy
ACTIVE COMPARATOR8 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.
Control- Healthy mothers and their babies
NO INTERVENTIONNo intervention for 8 weeks.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- women diagnosed with Post-Partum depression, major or minor, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th version (DSM-5)
- months after birth of one baby
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Interdisciplinary Center
Herzliya, 4610101, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Moran Influs, Phd
Interdisciplinary Center Herzliya, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 1, 2019
First Posted
December 10, 2019
Study Start
May 8, 2019
Primary Completion
October 1, 2024
Study Completion
December 1, 2024
Last Updated
May 29, 2024
Record last verified: 2024-05