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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

Be older than 18 years old

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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (t1), 1-month postpartum (t2), 2-months postpartum (t3), and 3-months postpartum (t4)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Cognitive Behavioural Therapy Skills Acquisition

Cost Effectiveness - Quality-Adjusted Life Year

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out