Online 1-Day CBT-Based Workshops for PPD

NCT04485000 | Completed DMC

• 1 other identifier: ONLINE1DAYCBT
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum depression (PPD) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. The purpose of this study is to a assess if self-referred, online adaptation of a 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop for PPD delivered up to 30 women at a time can lead to reductions in PPD, if the workshops are cost-effective, and to assess workshop impact on common complications of PPD (anxiety, partner relationship discord, problems with mother-infant attachment). 388 women will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control). Study measures will be collected at baseline (immediately before treatment workshop) and 12 weeks later (immediately before wait list control workshop).

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale (EPDS)

  The gold standard measure of PPD in clinical practice/research. Produces a score of 0-30, with higher scores indicating more severe depressive symptoms. A change of 4 points is recognized as a clinically meaningful/significant improvement.

  Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.

Secondary Outcomes (2)

• Cost-effectiveness: Costs of service

  Resources consumed over the 12-week trial period from the perspective of public healthcare payer will be measured.

• Cost-effectiveness: Quality-Adjusted Life Year (QALY)

  QALYs will be measured over the 12-week trial period.

Other Outcomes (5)

• Generalized Anxiety Disorder-7 (GAD-7)

  12 weeks

• Postpartum Bonding Questionnaire

  12 weeks

• Social Provisions Scale

  12 weeks

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

The experimental (immediate workshop) group will receive the online workshop at baseline (T1) in addition to receiving standard postnatal care.

Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop

Waitlist Cpntrol

OTHER

The waitlist control group will receive standard postnatal care for 12 weeks and will participate in the online 1-day CBT-based workshop at T2 (12 weeks post baseline).

Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop

Interventions

Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop BEHAVIORAL

The workshop is a day-long intervention delivered in 4 modules based on Cognitive Behavioural Therapy (CBT). The workshop covers PPD etiology, modifiable cognitive risk factors, cognitive skills, behavioural skills, problem solving, goal setting and action planning. Each participant is given a professionally designed manual to facilitate learning. Weekly reminder emails are sent for 6 weeks after the workshop completion to encourage practice. A list of PPD resources and a copy of the Canadian Treatment Guidelines for Postpartum Depression are provided.

Immediate Treatment; Waitlist Cpntrol

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
• infant under 12 months old
• EPDS score 10 or more
• Fluent in written/spoken English

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (2)

• Van Lieshout RJ, Layton H, Savoy CD, Brown JSL, Ferro MA, Streiner DL, Bieling PJ, Feller A, Hanna S. Effect of Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone for Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Nov 1;78(11):1200-1207. doi: 10.1001/jamapsychiatry.2021.2488.

  PMID: 34495285 DERIVED

• Layton H, Owais S, Savoy CD, Van Lieshout RJ. Depression, Anxiety, and Mother-Infant Bonding in Women Seeking Treatment for Postpartum Depression Before and During the COVID-19 Pandemic. J Clin Psychiatry. 2021 Jul 6;82(4):21m13874. doi: 10.4088/JCP.21m13874.

  PMID: 34232578 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ryan Van Lieshout, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and the research coordinator cannot be blinded to group condition, but staff making reminders and data analysts will not be aware of group status. Therapists delivering groups will be randomly assigned to workshops and not notified of group status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: April 20, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)