Clinical trial NCT04193462: 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
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Depression
Keywords: Post-partum depression
dyadic psychotherapy
oxytocin
Lead sponsor: Interdisciplinary Center Herzliya
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Behavioral Assessment of dialogue
timeFrame: trail 1-baseline
measure: Hormonal Assays- Oxytocin
timeFrame: trail 1-baseline
Secondary outcomes:
measure: Behavioral Assessment of dialogue
timeFrame: trail 2- after treatment- 2-3 months after trail 1
measure: Hormonal Assays- Oxytocin
timeFrame: trail 2- after treatment- 2-3 months after trail 1
Other outcomes:
Locations:
city: Herzliya
country: Israel
facility: Interdisciplinary Center
Study officials:
affiliation: Interdisciplinary Center Herzliya, Israel
name: Moran Influs, Phd
role: STUDY_DIRECTOR
References: