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

NCT05622305 | Completed

• 1 other identifier: PHN1DayCBT
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale (EPDS)

  The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score ≥13 is consistent with PPD and changes in scores \>4 are accepted as being indicative of clinically significant change.

  12 weeks

Secondary Outcomes (10)

• Edinburgh Postnatal Depression Scale (EPDS)

  6 months

• Generalized Anxiety Disorder 7-Item Scale

  12 weeks and 6 months

• Multidimensional Scale of Perceived Social Support (MSPSS)

  12 weeks and 6 months

• Parenting Stress Index (PSI-SF)

  12 weeks and 6 months

• Postpartum Bonding Questionnaire (PBQ

  12 weeks and 6 months

Other Outcomes (5)

• Client Satisfaction Questionnaire (CSQ-8)

  1 week post intervention in experimental arm

• CBT Skills Questionnaire (CBTSQ)

  12 weeks and 6 months in experimental arm

• Working Alliance Inventory (WAI-SR)

  1 week post intervention in experimental arm

Study Arms (2)

Online 1-Day CBT-Based Workshop

EXPERIMENTAL

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.

Behavioral: 1-Day Cognitive Behavioural Therapy-Based Workshop

Treatment as Usual

NO INTERVENTION

Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers.

Interventions

1-Day Cognitive Behavioural Therapy-Based Workshop BEHAVIORAL

The Online Workshop is a day-long intervention delivered by two trained public health nurses consisting of 6 hours of instruction delivered in 4 modules. The 1st contains information on PPD etiology with a focus on modifiable cognitive risk factors (e.g., negative thoughts, maladaptive core beliefs). The 2nd module focuses on cognitive skills including cognitive restructuring. The 3rd builds behavioural skills such as problem solving, behavioural activation, assertiveness, sleep strategies, and using supports. The final module provides an opportunity for goal setting/action planning. Teaching methods include didactic sections, group exercises, and role-plays. Regular breaks are incorporated. Each participant is given a professionally designed manual to facilitate learning. We also provide a list of region-specific PPD resources and a copy of the Canadian Practice Guidelines for the treatment of PPD.

Online 1-Day CBT-Based Workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• current bipolar, psychotic and/or substance use disorders

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ryan Vann Lieshout, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 18, 2022
• Study Start: October 11, 2022
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)