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Public Health Nurse-Delivered 1-Day CBT Workshops for PPD

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McMaster University

Status

Completed

Conditions

Postpartum Depression

Treatments

Behavioral: 1-Day Cognitive Behavioural Therapy-Based Workshop

Study type

Interventional

Funder types

Other

Identifiers

NCT05622305
PHN1DayCBT

Details and patient eligibility

About

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.

Full 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.

Enrollment

451 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

451 participants in 2 patient groups

Online 1-Day CBT-Based Workshop
Experimental group
Description:
Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered online by two trained public health nurses in addition to receiving usual care.
Treatment:
Behavioral: 1-Day Cognitive Behavioural Therapy-Based Workshop
Treatment as Usual
No Intervention group
Description:
Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers.

Trial contacts and locations

1

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Central trial contact

Haley Layton, MPH; Ryan Van Lieshout, MD, PhD

Data sourced from clinicaltrials.gov

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