NCT03654261

Brief Summary

Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

2.6 years

First QC Date

August 29, 2018

Last Update Submit

May 18, 2022

Conditions

Postpartum Depression

Keywords

Cognitive TherapyWorkshopPostpartum Depression

Outcome Measures

Primary Outcomes (2)

  • Edinburgh Postnatal Depression Scale (EPDS)

    EPDS is the 10-item gold standard measure of PPD. A score \>10 is consistent with PPD and changes in scores \>4 are accepted as being indicative of clinically significant change

    3 months

  • Beck Depression Inventory-II

    The Beck Depression Inventory is a 21-item scale that assesses the emotional and cognitive symptoms of depression as the EPDS does, but additionally captures the somatic symptoms of depression. Higher scores on the BDI-II indicate more sever depression. The minimum score is 0 and maximum score is 63. Items are summed to generate a total score. 0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression.

    3 months

Secondary Outcomes (8)

  • Generalized Anxiety Disorder-7 (GAD-7)

    3 months

  • Postpartum Bonding Questionnaire

    3 months

  • Client Satisfaction Questionnaire

    Immediately after workshop

  • Healthcare Utilization

    3 months

  • Infant Behaviour Questionnaire-Revised (Very short form)

    3 months

  • +3 more secondary outcomes

Study Arms (2)

1-Day CBT Workshop - Immediate

EXPERIMENTAL

Women assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart).

Behavioral: Cognitive Behavioural Therapy

1-Day CBT Workshop - Waitlist

EXPERIMENTAL

Women assigned to the waitlist will participate in the second of two workshops (12 weeks apart).

Behavioral: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural TherapyBEHAVIORAL

The intervention is a 1-day Cognitive Behavioural Therapy based workshop.

1-Day CBT Workshop - Immediate1-Day CBT Workshop - Waitlist

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • infant \<12 months
  • years or older
  • EPDS score \>10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (1)

  • 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: 34232578DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral 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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Psychiatry and Behavioural Neurosciences

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

January 1, 2018

Primary Completion

August 17, 2020

Study Completion

October 1, 2020

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)