Clinical trial NCT05622305: Public Health Nurse-Delivered 1-Day CBT Workshops for PPD
Official title: Public Health Nurse-Delivered 1-Day Cognitive Behavioural Therapy-Based Workshops for Postpartum Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 451
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 groups.
Primary purpose: TREATMENT

Brief summary: Public Health Nurses (PHN) received training to deliver a day-long Cognitive Behavioural Therapy (CBT)-based workshop for treating postpartum depression (PPD). Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months later.

The study will aim to determine if online day-long CBT-based workshops delivered by public health nurses can be added to treatment as usual to improve postpartum depression more than treatment as usual alone, iif the workshops are cost-effective, and if the workshops can stably improve depression, its common comorbidities and reduce adverse effects on the family.

Hypotheses: Online 1-Day CBT-Based Workshops delivered by PHNs will be an effective (and cost-effective) way to stably improve PPD, its comorbidities, and reduce its adverse effects on the family.

Detailed description: Postpartum depression (PPD) is one of the most common complications of childbirth, affecting 1 in 5 mothers. Left untreated, it increases the risk of future depressive episodes and can have profound effects on offspring. A single case of PPD has been estimated to cost as much as $150,000 over the lifespan, or $3 billion for each annual cohort of Canadian births.

Current clinical practice guidelines recommend evidence-based psychotherapies (e.g., cognitive behavioural therapy (CBT)) as 1st-line treatments for the vast majority of mothers with PPD. The key role that psychotherapy plays in the treatment of PPD is further emphasized by the US Preventive Services Task Force which recommends universal PPD screening, but only when CBT or other evidence-based counseling is available.

While treating PPD can reduce its adverse effects, safe, timely, accessible interventions are essential to optimizing outcomes. However, only treatments that can be upscaled can have an impact on PPD at the population level.

The delivery of psychotherapy in large groups (up to 30 participants) is a relatively new phenomenon, but may be capable of addressing mothers needs, as well as treating PPD on the scale required to address its prevalence. Brief (i.e., 1-Day) interventions contain the core content of more comprehensive, evidence-based interventions, but their brevity makes them easier to disseminate beyond traditional treatment settings (e.g., in public health). 1-Day CBT-Based Workshops have been delivered by trained mental health professionals (psychologists, psychiatrists) to treat generalized anxiety disorder and depression in general population samples, and postpartum depression.

Research Questions:

Primary: Can Online 1-Day CBT-Based Workshops for PPD delivered by Public Health Nurses (PHNs) added to treatment as usual (TAU) improve PPD more than TAU alone at 12 weeks post-treatment? Secondary: Can these workshops improve PPD at 6 months post-treatment and reduce levels of anxiety, parenting stress, partner relationship discord, improve parent-infant attachment, and reduce problems with temperament and behaviour in offspring at 3 and 6 months later? Tertiary: Are the workshops cost-effective?

A parallel-group Ontario-wide randomized controlled trial (RCT) with experimental (workshop) and TAU (control) groups will address our objectives. Participants in both groups will complete all study questionnaires and be compared at baseline, and 3 and 6 months later.

The experimental group will receive the Online 1-Day workshop (delivered by 2 PHNs) in addition to TAU, and the control group will receive TAU alone.

Participants will be mothers who have an infant under 12 months, who are 18 years or older, who are experiencing elevated symptoms of postpartum depression and who are free of current bipolar, psychotic and/or substance use disorders.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* have infant \<12 months at time of recruitment
* fluent in written/spoken English

Exclusion Criteria:

* current bipolar, psychotic and/or substance use disorders

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 6 months
measure: Generalized Anxiety Disorder 7-Item Scale
timeFrame: 12 weeks and 6 months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 12 weeks and 6 months
measure: Parenting Stress Index (PSI-SF)
timeFrame: 12 weeks and 6 months
measure: Postpartum Bonding Questionnaire (PBQ
timeFrame: 12 weeks and 6 months
measure: Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
timeFrame: 12 weeks and 6 months
measure: EQ-5D-5L
timeFrame: 12 weeks and 6 months
measure: Healthcare Resource Utilization Questionnaire
timeFrame: 12 weeks and 6 months
measure: Mini International Neuropsychiatric Interview - Major Depressive Disorder Module
timeFrame: 12 weeks and 6 months
measure: Mini International Neuropsychiatric Interview - Generalized Anxiety Disorder Module
timeFrame: 12 weeks and 6 months
Other outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 1 week post intervention in experimental arm
measure: CBT Skills Questionnaire (CBTSQ)
timeFrame: 12 weeks and 6 months in experimental arm
measure: Working Alliance Inventory (WAI-SR)
timeFrame: 1 week post intervention in experimental arm
measure: Group cohesion - Therapeutic Factors Inventory - 8 item
timeFrame: 1 week post intervention in experimental arm
measure: Fidelity of Intervention Delivery
timeFrame: 12 weeks
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Ryan Vann Lieshout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: