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Online CBT Workshop for Postpartum Depression

N/A
Recruiting
Led By Ryan J Van Lieshout, MD, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Past history of major depressive disorder (determined using the Mini International Neuropsychiatric Interview (MINI))
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (t1), 1-month postpartum (t2), 2-months postpartum (t3), and 3-months postpartum (t4)
Awards & highlights

Study Summary

This trial will test if an online CBT-workshop helps reduce rates of PPD when added to usual treatment. (n=410)

Who is the study for?
This trial is for adults over 18 in Ontario, Canada, who are in their third trimester of pregnancy but not currently experiencing a major depressive episode. Participants should have risk factors for postpartum depression such as low income, past depression or anxiety, recent major stress, single status, history of abuse, or low social support.Check my eligibility
What is being tested?
The study tests if an online one-day CBT-based workshop can reduce the rates of postpartum depression when added to usual treatment. It's a randomized controlled trial with half the participants receiving standard care and the other half also attending the workshop.See study design
What are the potential side effects?
Since this intervention involves non-invasive therapy (CBT), side effects may be minimal compared to medical treatments. However, some individuals might experience emotional discomfort discussing sensitive topics during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depressive disorder before.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (t1), 1-month postpartum (t2), 2-months postpartum (t3), and 3-months postpartum (t4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t1), 1-month postpartum (t2), 2-months postpartum (t3), and 3-months postpartum (t4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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-.
Secondary outcome measures
Infant Temperament (Infant Behaviour Questionnaire-Revised (IBQ-R))
Maternal Anxiety (Generalized Anxiety Disorder 7-Item Scale (GAD-7))
Maternal Perceived Stress (Perceived Stress Scale (PSS))
+2 more
Other outcome measures
Client Satisfaction (Client Satisfaction Questionnaire (CSQ-8))
Cognitive Behavioural Therapy Skills Acquisition
Cost Effectiveness - Quality-Adjusted Life Year
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Online 1-Day CBT-Based WorkshopExperimental Treatment1 Intervention
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.
Group II: Treatment as UsualActive Control1 Intervention
Participants assigned to the control arm will continue to receive standard prenatal care from their healthcare providers.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
879 Previous Clinical Trials
2,596,568 Total Patients Enrolled
12 Trials studying Postpartum Depression
2,751 Patients Enrolled for Postpartum Depression
Ryan J Van Lieshout, MD, PhDPrincipal InvestigatorMcMaster University
1 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Online 1-Day CBT-Based Workshop Clinical Trial Eligibility Overview. Trial Name: NCT05753176 — N/A
Postpartum Depression Research Study Groups: Online 1-Day CBT-Based Workshop, Treatment as Usual
Postpartum Depression Clinical Trial 2023: Online 1-Day CBT-Based Workshop Highlights & Side Effects. Trial Name: NCT05753176 — N/A
Online 1-Day CBT-Based Workshop 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753176 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this medical experiment?

"The clinical trial is actively recruiting subjects, as stated on the official website. This study was first announced on November 10th 2022 and has been modified most recently February 22nd 2023."

Answered by AI

What is the sample size for this research project?

"Yes, the information hosted by clinicaltrials.gov affirms that this experiment is open to recruitment. After initially being posted on November 10th 2022 and subsequently edited in February 22nd 2023, 410 individuals are sought from a single site for participation."

Answered by AI

What are the desired outcomes of this research endeavor?

"The primary aim of this clinical trial, which will be assessed over a 1, 2, and 3 month period after delivery is determining the presence or absence of major depressive episodes according to Edinburgh Postnatal Depression Scale (EPDS). Secondary objectives include evaluating Quality-Adjusted Life Year (QALY) with EQ-5D-5L's Canadian scoring algorithm for health utility at baseline and one, two and three months postpartum; Generalized Anxiety Disorder diagnosis using MINI International Neuropsychiatric Interview (MINI)'s module; as well as measuring severity through Generalized Anxiety Disorder 7 Item Scale (GAD–7), using"

Answered by AI
~160 spots leftby Mar 2025