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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04193462
Enrollment
100
Registered
2019-12-10
Start date
2019-05-08
Completion date
2024-12-31
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Partum Depression

Keywords

Post-partum depression, dyadic psychotherapy, oxytocin

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.

Interventions

OTHERPost-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.

OTHERPost-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

Sponsors

Interdisciplinary Center Herzliya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Behavioral Assessment of dialoguetrail 1-baselineInteractions 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- Oxytocintrail 1-baselineThree 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

MeasureTime frameDescription
Behavioral Assessment of dialoguetrail 2- after treatment- 2-3 months after trail 1Interactions 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- Oxytocintrail 2- after treatment- 2-3 months after trail 1Three 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

Countries

Israel

Contacts

Primary ContactMoran Influs, Phd
moran.influs@gmail.com972-545343400
Backup ContactRuth Feldman, Phd
feldman.ruth@gmail.com972-544566353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026