Clinical trial NCT05753176: Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression
Official title: Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Postpartum Anxiety
Keywords: cognitive behavioral therapy
CBT
postpartum depression
PPD
randomized controlled trial
RCT
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 408
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control group.
Primary purpose: PREVENTION

Brief summary: To conduct a randomized controlled trial (N=408) examining the impact of an online cognitive behavioural therapy (CBT)-based workshop on rates of postpartum depression (i.e., EPDS scores at 2-months postpartum) when added to treatment as usual (TAU) compared to TAU alone.

Detailed description: Postpartum depression affects up to 1 in 5 mothers, however just 15% receive evidence-based treatment. It is associated with negative consequences for women and their families with enormous costs to the healthcare system. Postpartum depression is an ideal candidate for prevention because it is common, the window of opportunity to intervene is clear (pregnancy), and its risk factors are well-established and easily identifiable. Furthermore, women are in frequent contact with the healthcare system during pregnancy and are more motivated to improve their health during this time than at any other time in their lives. Given the high rate of PPD and its adverse effects on mothers and their families, and the relative lack of efficient, effective psychotherapeutic interventions for preventing PPD, safe, novel, and efficient preventive interventions are needed. Since large 1-day workshops appear to successfully treat depression, given the widespread interest and investment of public health units across Canada in maternal and child health, Online 1-Day CBT-Based Workshops for Preventing PPD should be developed and tested for their ability to prevent PPD in Canadian women.

Based on longstanding clinical work with women at high risk for PPD, the development of a successful 1-Day CBT-Based Treatment Workshop for PPD and its delivery in-person and online, and an extensive review of the PPD prevention literature, the investigators developed the content for our prevention workshop as well as an accompanying script and intervention manual for participants in a previous pilot study. This pilot study also assessed feasibility by recruiting 32 women who took part in an online CBT-based workshop and provided feedback on its content, delivery and assessment procedures. The workshop, manual, and study protocol were subsequently refined and our experience recruiting participants in community settings into CBT treatment studies for PPD will be utilized in the current randomized controlled trial (N=408), which is aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk.

Objectives of the proposed randomized controlled trial are as follows:

Primary: To determine if Online 1-Day CBT-Based Workshops delivered to pregnant persons with a past history of major depressive disorder (MDD) and added to TAU reduces EPDS scores at 2-months postpartum more than TAU alone and to determine if these workshops reduce the risk of developing PPD (EPDS score ≥13 at 2 months postpartum).

Secondary: To determine if 1-Day CBT-based workshops lead to differences in the common comorbidities of PPD (maternal anxiety, problems with the mother-infant relationship, infant temperament, maternal social support, and maternal perceived stress) between the experimental and control groups.

Tertiary: To determine if 1-Day CBT-based workshops alter trajectories of PPD and its comorbidities from birth to three months postpartum and whether they are cost- effective.

Additional Analyses: A subgroup analysis will be conducted in those participants deemed as being of low socioeconomic status. The investigators will also conduct subgroup analyses to determine whether there are any differences in the magnitude of the treatment effect in participants that are single marital status, have a past history of abuse or have poor social support. Additional subgroup analyses will be conducted in those participants who are first time mothers, those who have generalized anxiety disorder, and those receiving treatment for past depression at baseline.

A prospective randomized controlled trial design will be used to address these objectives. The study will be advertised through our public health and community partners (i.e., midwifery associations) in Ontario, as well as on Facebook and Instagram. Participants will be allocated in a 1:1 ratio to experimental (1-Day CBT Workshop in addition to TAU) or control (TAU alone) groups. Both experimental and control groups will complete data collection at baseline (before completing the 1-Day CBT workshop for experimental group participants), and at 1, 2 and 3 months postpartum.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Currently residing in Ontario, Canada
* Currently in 3rd trimester of pregnancy (28-36 weeks gestation)
* EPDS score \>6
* Past history of major depressive disorder (determined using the Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

* positive score on the MINI for a current major depressive episode
* positive score on the MINI subsections of bipolar, psychotic, or borderline personality disorder

Primary outcomes:
measure: EPDS score as a continuous outcome (Total EPDS) and an EPDS score of 13 or more at 2-months postpartum (T3) will serve as co-primary outcomes.
timeFrame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Secondary outcomes:
measure: Maternal Anxiety (Generalized Anxiety Disorder 7-Item Scale (GAD-7))
timeFrame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
measure: Maternal Social Support (MSPSS)
timeFrame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
measure: Maternal Perceived Stress (Perceived Stress Scale (PSS))
timeFrame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
measure: Problems with the Mother-Infant Relationship (Postpartum Bonding Questionnaire (PBQ))
timeFrame: 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
measure: Infant Temperament (Infant Behaviour Questionnaire-Revised (IBQ-R))
timeFrame: 3-months postpartum (T4)
Other outcomes:
measure: Cost-Effectiveness - Healthcare Costs
timeFrame: Baseline (T1) (mother only) and 3-months postpartum (T4) (infant and mother)
measure: Cost Effectiveness - Quality-Adjusted Life Year
timeFrame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
measure: Client Satisfaction (Client Satisfaction Questionnaire (CSQ-8))
timeFrame: 1 week post-intervention in the experimental arm
measure: Client Satisfaction (Client Satisfaction Questionnaire (CSQ-8))
timeFrame: 3-months postpartum (T4)
measure: Cognitive Behavioural Therapy Skills Acquisition
timeFrame: 1-month postpartum (T2) and 3-months postpartum (T4)
measure: Major Life Stress in the Past 12 Months
timeFrame: Baseline (T1)
measure: Socioeconomic Disadvantage
timeFrame: Baseline (T1)
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Ryan J Van Lieshout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: