Clinical trial NCT04928742: Online PHN CBT for PPD
Official title: Online Public Health Nurse-Delivered Group Cognitive Behavioural Therapy for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 159
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 (online PHN-delivered group CBT) or the control group (treatment as usual).
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.

Detailed description: A prospective, 1-site, parallel group, RCT (1:1 ratio) in which outcome assessors and data analysts will be blinded to maternal treatment will be used to compare online PHN-delivered group CBT for PPD to postnatal care as usual.

The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.

Women in the treatment group will participate in a 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.

Eligibility criteria: Inclusion Criteria:

* Eligible women will be \>18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between of 10 or more and meet diagnostic criteria for current major depressive disorder on the Mini International Neuropsychiatric Interview-Plus (MINI-Plus). They will also all be within 12 months of delivering an infant.

Exclusion Criteria:

* In order to increase the relevance and generalizability of our findings, women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder. These are predictors of significant difficulty participating in therapy groups and/or non-response to CBT.

Primary outcomes:
measure: Maternal Depressive Symptoms
timeFrame: 9 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: 9 weeks
measure: Mother-Infant Bonding
timeFrame: 9 weeks
measure: Social Support
timeFrame: 9 weeks
measure: Social Support
timeFrame: 6 months
measure: Relationship with Partner
timeFrame: 6 months
measure: Relationship with Partner
timeFrame: 9 weeks
measure: Infant Temperament
timeFrame: 9 weeks
measure: Infant Temperament
timeFrame: 6 months
measure: Cost Effectiveness - costs
timeFrame: 9 weeks
measure: Cost Effectiveness - QALY
timeFrame: 9 weeks
measure: Cost Effectiveness - costs
timeFrame: 6 months
measure: Cost Effectiveness - QALY
timeFrame: 6 months
measure: Maternal Major Depressive Disorder
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Mother-Infant Bonding
timeFrame: 6 months
measure: Maternal Major Depressive Disorder
timeFrame: 9 weeks
measure: Maternal Depressive Symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Ryan Van LIeshout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: