Clinical trial NCT05269732: CBT for Postpartum Depression and Infant Emotion Regulation
Official title: The Impact of Treating Postpartum Depression on Infant Emotion Regulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned in a 1:1 ratio to the treatment group (delivered group CBT plus TAU) or the control group (treatment as usual).
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if online group cognitive behavioral therapy (CBT) for maternal postpartum depression (PPD) added to treatment as usual (TAU) leads to greater improvements in infant emotion regulation (ER) than maternal receipt of TAU alone immediately post-treatment and 6 months later. This study will also aim to determine what mechanisms PPD treatment leads to changes in infant ER.

Detailed description: A prospective, single-blind, parallel randomized controlled trial (1:1 ratio) that includes an experimental (receipt of a 9-week group CBT intervention delivered online plus TAU) and control group (TAU alone) to address our objectives. Participants will have an EPDS score of 10 or more and an infant 3-12 months of age and be recruited from the community. The experimental group will receive a validated 9-week online group cognitive behavioral therapy (CBT) intervention on Zoom plus TAU. The control group will receive TAU alone. In both groups, TAU will consist of regular care from their family doctor, midwife, OB/GYN an/or any other types of care they may be accessing. The trial intervention consists of nine, 2-hour sessions occurring once per week. The first half of each session is devoted to core CBT content, including cognitive restructuring. The second half is devoted to group discussions co-led by participants on topics relevant to mothers with PPD (e.g., sleep, supports, role transitions). Groups will be delivered by two trained psychologists, social workers, nurses, and/or psychiatrists. Primary objective: Determine if online group cognitive behavioural therapy (CBT) for maternal PPD added to treatment as usual (TAU) lead to greater improvements in infant ER than maternal receipt of TAU alone immediately post-treatment and 6 months later. Secondary objective: Determine the putative mechanisms through which PPD treatment leads to changes in infant ER.

Eligibility criteria: Inclusion Criteria:

* women 18 years of age or older
* understand and speak English (so that they can participate in the CBT group and complete study measures)
* live in Ontario (the primary WHCC catchment area)
* have an EPDS score of 10 or more
* meets diagnostic criteria for comorbid psychiatric conditions.
* Infants must be between 4-12 months old at enrollment.

Exclusion Criteria:

* bipolar disorder
* a current psychotic disorder
* substance or alcohol use disorder
* antisocial or borderline personality disorder.

Primary outcomes:
measure: Infant Temperament
timeFrame: 6 months
measure: Infant emotion regulation
timeFrame: 6 months
measure: Maternal Depression
timeFrame: 6 months
measure: Maternal Anxiety
timeFrame: 6 months
Secondary outcomes:
measure: Brain-to-brain Synchrony (fNIRS)
timeFrame: 6 months
measure: The Face-to-Face Stillage Paradigm (FFSP)
timeFrame: 6 months
measure: Parent-Child Early Relational Assessment (PCERA)
timeFrame: 6 months
measure: Epigenetic Analyses
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: Mcmaster
name: Ryan Van Lieshout, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: