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Depression, PostpartumNCT03039530

Group CBT for PPD in the Public Health Setting

A study testing Group Cognitive Behavioral Therapy and Postnatal Care As Usual in people with Depression, Postpartum, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have profound effects on mothers, their children, and their families. The cost of one case of PPD exceeds $150,000, a significant proportion of which is related to its impact on offspring. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Depression, Postpartum
What is being tested?
Group Cognitive Behavioral Therapy and Postnatal Care As Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
1 siteCanada
Study dates
1 Apr 2017to 1 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible women will be >18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between 10 and 23. They will also all be within 12 months of delivering an infant

Who cannot join

  • Women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Niagara Region Public Health

    Thorold, Ontario, L2V 4Y6

Other trials in Canada

About this study

Official title: Impact of Public Health Nurse Delivered Group CBT for Postpartum Depression on Women and Their Children: A Randomized Controlled Trial

Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have profound effects on mothers, their children, and their families. The cost of one case of PPD exceeds $150,000, a significant proportion of which is related to its impact on offspring. However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer than 15% of women receiving care. While Public Health Units have played an important role in PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group format is effective for treating depression in the perinatal period, and as PHNs are often the first point of contact for women experiencing PPD, with specialized training it is likely that they can deliver high-quality CBT.

The primary objective of this study is to determine if PHNs can be trained to deliver group Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence, improve mother-infant attachment and parenting and optimize infant emotional functioning.

Read the detailed description

In addition to its effects on maternal health, PPD can adversely affect mother-infant attachment, parenting, and the development and health of her children. The negative effects of PPD on offspring can include an increased risk of insecure attachment, poorer cognitive, language, and behavioral development, as well as an increased risk of emotion regulatory problems. To determine if PHNs can effectively deliver group CBT for PPD that is superior to postnatal care as usual, the investigators will proceed with a randomized controlled trial (RCT). Women in the treatment group will attend a 9-week group CBT intervention delivered by trained PHNs. Those in the control group will receive standard postnatal care.

This RCT will compare the effects of group CBT to postnatal care as usual on maternal depression, anxiety, mother-infant attachment, parenting, healthcare utilization and social support, as well as infant development, emotion regulation, and healthcare utilization

Being tested
Group Cognitive Behavioral Therapy, Postnatal Care As Usual
Keywords
Postpartum Depression, Cognitive Behavioral Therapy, Public Health, Mother, Infant, Emotion
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Cognitive Behavioral TherapyBehavioural

    9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.

  • Postnatal Care As UsualBehavioural

    Postnatal care as usual will involve treatment from their family physician and midwife or obstetrician, and voluntary participation in programs offered by Niagara Region Public Health and in the community.

Study groups in NCT03039530
Study groupRoleWhat they receive
Treatment GroupExperimentalGroup CBT for PPD. Women in the treatment group will attend a 9-week group CBT intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.
Receives: Behavioral: Group Cognitive Behavioral Therapy
Control GroupActive comparatorStandard Care. The usual care group will receive standard care from their family physician and midwife or obstetrician. They will also be made aware of the perinatal programming available to them through Niagara Region Public Health. Women and family physicians will also receive a copy of the Canadian Practice Guidelines for the Treatment of Perinatal Depression.
Receives: Behavioral: Postnatal Care As Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Edinburgh Postnatal Depression Scale (EPDS)

    The EPDS will be used to assess maternal depression. A score of >12 is consistent with PPD and changes in scores >4 are indicative of clinically significant improvement.

    Measured: 6 months

  2. Mini International Neuropsychiatric Interview - Current Major Depressive Disorder

    Used to assess maternal depression.

    Measured: 6 months

Secondary outcomes (11)

  1. Penn State Worry Questionnaire (PSWQ)

    Maternal Anxiety will be assessed using the Penn State Worry Questionnaire.

    Measured: 6 months

  2. Postpartum Bonding Questionnaire

    Used to detect disorders of the mother-infant relationship.

    Measured: 6 months

  3. Parent-Child Early Relational Assessment

    Used to measure the quality of affect and behavior in parent-child interactions.

    Measured: 6 months

  4. Social Provisions Scale

    Used to measure the degree to which mothers' social relationships provide support

    Measured: 6 months

  5. Ages and Stages Questionnaires - Third Edition

    Assesses infant communication, motor and socioemotional development using age-specific scales.

    Measured: 6 months

  6. Maternal & Infant Healthcare Utilization

    Adopted form the Canadian Community Health Survey to track use of healthcare services.

    Measured: 6 months

  7. Infant Behaviour Questionnaire-Revised

    This scale assesses infant temperament

    Measured: 6 months

  8. Face-to-Face Still Face Paradigm

    Experimental task used to assess emotion regulation in infants

    Measured: 6 months

  9. Parasympathetic Nervous System Functioning: Heart Rate Variability

    Used to asses the flexibility of the central and peripheral nervous system to handle stress.

    Measured: 6 months

  10. Salivary Cortisol

    Used to assess stress reactivity and emotion regulation. Three samples will be taken during each assessment: 10-15 minutes after the beginning of the assessment, 15-20 minutes after the face-to-face still face task and at the end of the visit.

    Measured: 6 months

  11. Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)

    Corticolimbic brain activity at the scalp will be assessed using electroencephalography (EEG). Greater left frontal asymmetry (greater activity in the left frontal hemisphere) is thought to reflect positive emotionality and indicate a greater tendency to engage in more adaptive emotion regulation strategies. However greater right activity reflects a tendency to engage in withdrawn behaviours and negative emotionality.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2017 (estimated)
  2. Study start1 Apr 2017
  3. Primary completion1 Jan 2021
  4. Study completion1 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03039530
Sponsor's protocol ID
PH CBT
Status last verified
Apr 2021
First submitted
19 Jan 2017
Last updated
19 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • George KV, Savoy CD, Layton H, Bieling PJ, Van Lieshout RJ. Prevalence of Comorbid Postpartum Depression and Anxiety in Birthing Parents Seeking Treatment for Postpartum Depression: Prevalence de la presence comorbide de la depression et de l'anxiete post-partum chez les parents ayant accouche qui ont consulte en raison de la depression post-partum. Can J Psychiatry. 2026 Jul 1:7067437261462698. doi: 10.1177/07067437261462698. Online ahead of print.

    PubMed 42383885

  • Van Lieshout RJ, Layton H, Savoy CD, Haber E, Feller A, Biscaro A, Bieling PJ, Ferro MA. Public Health Nurse-delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial. Can J Psychiatry. 2022 Jun;67(6):432-440. doi: 10.1177/07067437221074426. Epub 2022 Jan 21.

    PubMed 35060398

Questions about this trial

What is this clinical trial studying?

A study testing Group Cognitive Behavioral Therapy and Postnatal Care As Usual in people with Depression, Postpartum, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Edinburgh Postnatal Depression Scale (EPDS) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03039530, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.

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