Public Health Nurse-Delivered 1-Day CBT Workshops Pilot

NCT05314361 | Completed

• 1 other identifier: PHN1DayCBTPilot
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Public Health Nurses received training to deliver a day-long Cognitive Behavioural Therapy-based workshop for treating postpartum depression. 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. The study will aim to assess the feasibility of our methods and estimate the treatment effect of the primary outcome in preparation for a larger RCT. Objectives include:

• Recruit and randomize 96 participants within 5 months
• Questionnaire completion - 75% of participants complete all three questionnaires and structured interviews
• Retention - 75% of participants remain in study until completion
• 75% of participants in treatment group complete the intervention
• Estimate treatment effect and variance

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (4)

• Number of participants recruited in recruitment period

  Recruit and randomize 96 participants within 5 months (48 treatment into four 1-day workshops (12 per workshop) and 48 control)

  5 months

• Number of participants who complete all data collection procedures

  75% of participants complete all data collection procedures at all time points

  6 months

• Number of participants who complete study (retention)

  75% of participants remain enrolled in the study until completion

  6 months

• Number of participants who complete the intervention (adherence)

  75% of participants who are enrolled in the treatment group will complete the 1-Day CBT-based workshop

  6 months

Secondary Outcomes (1)

• Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)

  3 months

Other Outcomes (23)

• GAD-7

  3 months

• GAD-7

  6 months

• Multidimensional Scale of Perceived Social Support (MSPSS)

  3 months

Study Arms (2)

Treatment - 1 Day CBT-Based Workshop

EXPERIMENTAL

Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered by two trained public health nurses in addition to receiving usual care.

Behavioral: 1-Day Cognitive Behavioural Therapy-Based Workshop

Control - usual care

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 (written by the NPA).

Treatment - 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

Related Publications (1)

• Layton H, Campbell M, Huh K, Mansoor A, Serrano-Lomelin J, Brown JSL, Bieling PJ, Van Lieshout RJ. Public Health Nurse-Delivered 1-Day Cognitive Behavioral Therapy-Based Workshops for Treating Postpartum Depression: A Pilot Randomized Controlled Trial. J Clin Psychiatry. 2025 Apr 30;86(2):24m15712. doi: 10.4088/JCP.24m15712.

  PMID: 40315102 DERIVED

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 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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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: March 21, 2022
• First Posted: April 6, 2022
• Study Start: March 18, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)