Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression

NCT05753176 | Active Not Recruiting

• 1 other identifier: RCT1-day CBT to prevent PPD
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression; Postpartum Anxiety

Keywords

cognitive behavioral therapy; CBT; postpartum depression; PPD; randomized controlled trial; RCT

Outcome Measures

Primary Outcomes (1)

• 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.

  Edinburgh Postnatal Depression Scale (EPDS): the gold standard measure of PPD symptoms in clinical practice and research. The EPDS is a self-report 10-item scale scored out of 30 points that measures the severity of depressive symptoms in the past 7 days. Scores are between 0 and 30, with higher scores indicating the presence of more depressive symptoms. Scores of 13 and above indicate depressive illness, or a high risk of developing a depressive disorder. A reduction of four points in the EPDS is recognized as a clinically significant improvement.

  Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)

Secondary Outcomes (5)

• Maternal Anxiety (Generalized Anxiety Disorder 7-Item Scale (GAD-7))

  Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)

• Maternal Social Support (MSPSS)

  Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)

• Maternal Perceived Stress (Perceived Stress Scale (PSS))

  Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)

• Problems with the Mother-Infant Relationship (Postpartum Bonding Questionnaire (PBQ))

  1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)

• Infant Temperament (Infant Behaviour Questionnaire-Revised (IBQ-R))

  3-months postpartum (T4)

Other Outcomes (7)

• Cost-Effectiveness - Healthcare Costs

  Baseline (T1) (mother only) and 3-months postpartum (T4) (infant and mother)

• Cost Effectiveness - Quality-Adjusted Life Year

  Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)

• Client Satisfaction (Client Satisfaction Questionnaire (CSQ-8))

  1 week post-intervention in the 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 facilitators in addition to receiving usual care.

Behavioral: Online 1-Day Cognitive Behavioural Therapy-Based Workshop

Treatment as Usual

NO INTERVENTION

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

Interventions

Online 1-Day Cognitive Behavioural Therapy-Based Workshop BEHAVIORAL

The Online Workshop is a day-long intervention delivered by two trained facilitators (i.e., psychotherapists, social workers, nurses, and/or a psychiatrist) 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. Participants are also given 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: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (1)

• Boland Z, Lloyd N, Drage J, Serrano-Lomelin J, Bieling P, Streiner D, Van Lieshout RJ. One-Day Online Cognitive Behavioral Therapy-Based Workshops for the Prevention of Postpartum Depression: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Apr 16;86(2):24m15674. doi: 10.4088/JCP.24m15674.

  PMID: 40257965 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 Officials

• Ryan J Van Lieshout, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and the research coordinator cannot be blinded to group condition though the research assistants sending out 1, 2, and 3 month postpartum follow questionnaires and data analysts will not be aware of group status.
• Purpose: PREVENTION
• 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 group.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 3, 2023
• Study Start: November 10, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)