NCT06597448

Brief Summary

The purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating PPD when delivered in addition to treatment as usual (TAU) compared to TAU alone. The study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of PPD and whether it is cost-effective.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress50%
Sep 2024Jan 2028

First Submitted

Initial submission to the registry

September 11, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

September 11, 2024

Last Update Submit

December 2, 2025

Conditions

Postpartum Depression

Keywords

Postpartum depression, PPDCognitive Behavioural TherapyPublic Health NursePeer

Outcome Measures

Primary Outcomes (4)

  • Postpartum Depression

    PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms at 9 weeks (i.e., immediately post-treatment). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement.

    9 weeks (post treatment/intervention)

  • Major Depressive Disorder

    We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation.

    9 weeks (post treatment/intervention)

  • Major Depressive Disorder

    We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation.

    6 months (durability of intervention effects)

  • Postpartum Depression

    PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms 6 months later (i.e., to assess durability of intervention effects). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement.

    6 months (durability of intervention effects)

Secondary Outcomes (18)

  • Parenting Stress

    9 weeks (post treatment/intervention)

  • Parenting Stress

    6 months (durability of intervention effects)

  • Healthcare Resource Utilization Questionnaire

    9 weeks (post treatment/intervention)

  • Healthcare Resource Utilization Questionnaire

    6 months (durability of intervention effects)

  • Other Psychiatric Disorders

    9 weeks (post treatment/intervention)

  • +13 more secondary outcomes

Other Outcomes (6)

  • Fidelity of Intervention Delivery

    Weekly during the 9-week intervention

  • Assess Participant Satisfaction

    9-week (post treatment/intervention)

  • Psychotherapy Experience

    9 weeks (post treatment/intervention)

  • +3 more other outcomes

Study Arms (2)

Online CBT Group

EXPERIMENTAL

Participants randomized to the Intervention group will attend a 9-week online CBT group co-led by a Public Health Nurse and a Peer (individual who has recovered from PPD and received training to deliver the intervention) in addition to receiving usual care.

Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD)

Treatment as Usual

NO INTERVENTION

Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed.

Interventions

Cognitive Behavioral Therapy for Postpartum Depression (PPD)BEHAVIORAL

Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The intervention consists of 9- 2hr sessions, the first half involves teaching and practice of CBT skills (cognitive restructuring, thinking errors, problem solving etc) followed by one hour of unstructured discussion around topics relevant to participants with Postpartum Depression (PPD) (sleep, supports, transitions, etc). Each group will be delivered by one randomly selected PHN and one randomly selected peer using our intervention manual.

Online CBT Group

Eligibility Criteria

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

You may qualify if:

  • Mothers or birthing parents, 18 years old, have an infant under 12 months of age at recruitment, fluent in written/spoken English, have a Edinburgh Postnatal Depression Scale (EPDS) score ≥10 and live in Ontario, Canada.

You may not qualify if:

  • Bipolar, psychotic, or current substance use disorders and borderline personality disorder as assessed during screening when study coordinator administers the Mini International Neuropsychiatric Interview (MINI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

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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 J Van Lieshout, MD, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Data analysts will be blinded. Data is deidentified and a study ID number is assigned. Research assistants following up with T2 and T3 questionnaires and phone interviews will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants who have met the eligibility requirements and signed the consent form are randomized and allocated in a 1:1 ratio to one of two groups: Intervention (those who participate in the 9-week CBT group along with treatment as usual) and Control (continue with treatment as usual alone). Control group participants receive a list of mental health resources. Both groups complete online questionnaires at 3 timepoints: enrollment (T1), 9 weeks later (T2-post intervention for those in the intervention group) and 6 months later (T3).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

September 16, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

No individual participant data will be available to other researchers

Locations

CA(1)