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Postpartum DepressionPL-OCBTNCT04913584

Peer Administered Online CBT for PPD

A study testing Cognitive Behavioural Therapy in people with Postpartum Depression, 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 up to one in five of women and has profound effects on mothers and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based care. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Depression
What is being tested?
Cognitive Behavioural Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
1 siteCanada
Study dates
25 Aug 2020to 22 Feb 2022
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • >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 >10
  • Be within 12 months of delivering an infant
  • Live within a 2-hour radius of the Brant Region.

Who cannot join

  • Bipolar disorder
  • Current psychotic disorder
  • Substance use disorder
  • Alcohol use disorder
  • Antisocial or borderline personality disorder

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Kids Can Fly

    Brantford, Ontario, N3L 3E1

Other trials in Canada

About this study

Official title: Online Peer-Delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial

Postpartum depression (PPD) affects up to one in five of women and has profound effects on mothers and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based care. This is at least partly due to significant difficulties faced by women in accessing psychotherapies, their preferred treatment for PPD. Around the world, there is a significant lack of healthcare professionals trained to deliver CBT. This study will utilize a randomized controlled trial design (with wait-list controls) and recruit 174 participants to determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver effective group CBT online to women currently struggling with PPD. If peers can be trained to provide effective CBT, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced.

Read the detailed description

Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers and their infants. Indeed, the cost of one case of PPD is estimated to exceed $150,000. Unfortunately, fewer than 15% of women with PPD receive evidence-based care and this is at least partly due to difficulties accessing treatment, particularly those that are most preferred (e.g., psychotherapy).

Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment and that screening only occur in settings where CBT is readily available. In order to increase access to treatment, screening efforts have been undertaken by public health units across Canada. This is despite recommendations that this only be conducted in the setting of timely access to evidence-based psychotherapies (e.g., CBT). The purpose of this study is to apply task shifting to the treatment of PPD by determining if women with a past history of PPD (i.e., lay peers) living in the community can be trained to deliver effective group CBT to women with current PPD.

A group CBT intervention for PPD has been developed and validated as well as a training program that pilot data suggests is capable of successfully training public health nurses with little background psychiatric training. This intervention is brief, effective, and generalizable to women with PPD in the community. Peer administered interventions (PAIs), those delivered by recovered former patients are increasingly recognized as potentially effective alternatives to traditional mental health care services. In addition, psychotherapy delivered online has been recognized as a delivery method that results in successful expression and interpretation of emotions, decreased inhibition and reluctance to disclose personal information and a strong therapeutic alliance between patients and providers. Online psychotherapy also has satisfaction ratings that are comparable to traditional in-person psychotherapy.

Eight lay peers will be trained to deliver our 9-week group CBT treatment. 174 women will be recruited and using a randomized controlled trial design (with wait-list controls), it will be determined if lay peers can deliver effective group CBT for PPD.

If peers can be trained to provide effective CBT online, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.

Being tested
Cognitive Behavioural Therapy
Keywords
Postpartum depression, CBT, Lay Peer, Online therapy
Medical subject headings
Depression, Postpartum

What participants receive

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

  • Cognitive Behavioural TherapyBehavioural

    Cognitive Behavioral Therapy 9 weekly 2-hour online group CBT sessions delivered by trained lay peers.

Study groups in NCT04913584
Study groupRoleWhat they receive
Immediate InterventionExperimentalOnline Group CBT for PPD. Women in the treatment group will attend an online 9-week group Cognitive Behavioural Therapy intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton and 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. The CBT intervention will be delivered by eight lay-peers.
Receives: Behavioral: Cognitive Behavioural Therapy
Wait-List ControlsExperimentalOnline Group CBT for PPD 9 weeks after enrollment. The women in this arm of the study will receive the same Cognitive Behavioural Therapy intervention as in the immediate intervention arm, however, they will begin the CBT group 9 weeks after enrolling in the study.
Receives: Behavioral: Cognitive Behavioural Therapy

What is being measured

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

  1. Edinburgh Postnatal Depression Scale

    The EPDS will be used to assess maternal depression. A score of >10 is consistent with probable PPD and changes in scores >4 are indicative of clinically significant improvement.

    Measured: 6 months

Secondary outcomes (10)

  1. Postpartum Bonding Questionnaire

    Used to detect disorders of the mother-infant relationship. Higher scores indicate more impaired bonding.

    Measured: 6 months

  2. Social Provisions Scale

    Used to measure the degree to which mothers' social relationships provide support. Higher scores indicate higher levels of social support.

    Measured: 6 months

  3. Canadian Community Health Survey Maternal Healthcare Utilization

    Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.

    Measured: 6 months

  4. Adult Adolescent Parenting Inventory

    Used to assess the parenting and child rearing attitudes of parents. Higher scores indicate lower risk parenting.

    Measured: 6 months

  5. EuroQol-5D

    Used to measure health-related quality of life. Higher scores indicate more severe or frequent problems.

    Measured: 6 months

  6. Generalized Anxiety Disorder-7

    Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression. Higher scores indicate more severe generalized anxiety disorder symptoms.

    Measured: 6 months

  7. Mini International Neuropsychiatric Interview - Current Major Depressive Disorder

    Used to assess maternal depression.

    Measured: 6 months

  8. Parenting Stress Index (Short-Form)

    Used to measure stress in parent-child relationships. Higher scores indicate higher levels of stress.

    Measured: 6 months

  9. Infant Behavior Questionnaire-Revised

    Used to measure infant temperament. Higher scores indicate greater levels of the specific temperament dimension.

    Measured: 6 months

  10. Ages and Stages Questionnaire

    Used to measure communication and motor development in children. Higher scores indicate more positive outcomes.

    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 posted4 Jun 2021
  2. Study start25 Aug 2020
  3. Primary completion22 Feb 2022
  4. Study completion22 Feb 2022

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
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913584
Sponsor's protocol ID
PL OCBT
Acronym
PL-OCBT
Status last verified
Apr 2022
First submitted
29 May 2021
Last updated
19 Apr 2022
Results posted
No
Data monitoring committee
Yes
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

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioural Therapy in people with Postpartum Depression, 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 5 inclusion and 5 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 2022. 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 (time frame: 6 months). 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 NCT04913584, which also lists 1 linked publication.

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 2022.

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