Cognitive Behavioral Therapy for Postpartum Depression

Overseen By Ryan J Van Lieshout, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Bipolar, Psychotic, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 9 weeks

170 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. It seems to allow treatment as usual, so you might be able to continue your current medications.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Postpartum Depression?

Research shows that Cognitive Behavioral Therapy (CBT) can effectively reduce symptoms of postpartum depression and anxiety, improve social support, and enhance the mother-infant relationship. Studies have demonstrated that both in-person and online group CBT sessions, as well as brief and one-day workshops, can be beneficial for mothers experiencing postpartum depression. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for postpartum depression?

Cognitive Behavioral Therapy (CBT) is generally considered safe for treating postpartum depression, as it is a non-invasive, talk-based therapy that does not involve medication. ^{1 3 4 5 6}

How does cognitive behavioral therapy differ from other treatments for postpartum depression?

Cognitive Behavioral Therapy (CBT) for postpartum depression is unique because it can be delivered in various flexible formats, such as group sessions led by public health nurses, one-day workshops, or online peer-led groups, making it accessible to more people. Unlike medication, CBT focuses on changing negative thought patterns and behaviors, which can be particularly beneficial for new mothers who may prefer non-drug interventions. ^{1 3 4 5 6}

Research Team

Ryan Van Lieshout, MD, PhD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for individuals experiencing postpartum depression. Participants should be new mothers who can access online therapy sessions and are currently receiving standard treatment for PPD. The study excludes those with severe psychiatric conditions or other factors that would interfere with group therapy.

Inclusion Criteria

Fluent in written/spoken English

Edinburgh Postnatal Depression Scale (EPDS) score ≥10

Living in Ontario, Canada

Exclusion Criteria

Assessment during screening using the Mini International Neuropsychiatric Interview (MINI)

History of bipolar disorder, psychotic disorder, current substance use disorders, or borderline personality disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 9-week online group Cognitive Behavioral Therapy (CBT) intervention co-led by public health nurses and peers, in addition to treatment as usual

9 weeks

Weekly online sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 9 weeks and 6 months post-intervention

6 months

Assessments at 9 weeks and 6 months

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Postpartum Depression (PPD)

Trial Overview The trial tests a 9-week online Cognitive Behavioral Therapy program co-led by public health nurses and peers recovered from PPD, alongside usual care. It aims to see if this improves outcomes over standard care alone, considering anxiety, parenting stress, social support, and infant temperament.

Participant Groups

Group I: Online CBT Group Experimental Treatment 1 Intervention

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.

Group II: Treatment as Usual Active Control 1 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.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Niagara Region Public Health

Collaborator

Trials

4

Recruited

770+

Findings from Research

A study evaluating preventive cognitive behavioral therapy (CBT) for postpartum depression (PPD) found that while the prevalence of PPD was higher in the risk group (5.5%) compared to the control group (2.2%), the difference was not statistically significant, indicating that CBT may not drastically reduce PPD rates in this population.

The therapy showed gradual improvement in mental health scores (OQ-45) during sessions, suggesting that brief CBT can be effective in reducing symptoms and preventing PPD, especially among women with higher education levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief cognitive behavioral therapy in pregnant women at risk of postpartum depression: Pre-post therapy study in a city in southern Brazil. Pinheiro, RT., Trettim, JP., de Matos, MB., et al.[2021]

A 9-week group cognitive-behavioral therapy (CBT) intervention delivered by peers significantly reduced symptoms of postpartum depression (PPD) and anxiety in 73 mothers, with improvements remaining stable at a 6-month follow-up.

The intervention also enhanced mother-infant bonding and reduced feelings of rejection and anger, suggesting it not only addresses mental health symptoms but also improves the overall mother-infant relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial. Amani, B., Merza, D., Savoy, C., et al.[2022]

A randomized controlled trial with 183 participants showed that a 9-week online group cognitive-behavioral therapy (CBT) led by peers significantly reduced postpartum depression (PPD) and anxiety symptoms, with improvements lasting for at least 3 months after the intervention.

The study also found enhancements in maternal social support and reductions in infant-focused anxiety and negative emotionality, suggesting that this peer-delivered approach could effectively increase access to treatment for PPD and benefit families overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial. Merza, D., Amani, B., Savoy, C., et al.[2023]

A one-day cognitive behavioral therapy (CBT) workshop significantly reduced postpartum depression (PPD) scores in 461 mothers and birthing parents, with participants showing three times higher odds of clinically significant improvement compared to those receiving treatment as usual.

The workshop also led to decreased anxiety and improved mother-infant relationships, while being cost-effective, suggesting it could be a valuable addition to perinatal care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-person 1-day cognitive behavioral therapy-based workshops for postpartum depression: a randomized controlled trial. Van Lieshout, RJ., Layton, H., Savoy, CD., et al.[2023]

A pilot study involving seven women showed that group Cognitive Behavioural Therapy (CBT) delivered by public health nurses is feasible and acceptable for treating postpartum depression (PPD).

Participants experienced significant reductions in depression and worry, improved mother-infant relations, and decreased health care visits, indicating that this intervention could effectively alleviate the burden of PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public health nurse delivered group cognitive behavioral therapy (CBT) for postpartum depression: A pilot study. Van Lieshout, RJ., Layton, H., Feller, A., et al.[2021]

Early identification of mothers at risk for postpartum depression (PPD) using the Edinburgh Postnatal Depression Scale (EPDS) is crucial for effective prevention, as demonstrated in a study involving mothers recruited just two days after childbirth.

Cognitive Behavioral Therapy (CBT) significantly improved EPDS scores in high-risk mothers, while those identified as low-risk without CBT showed higher EPDS scores at 12 months, indicating that early intervention can effectively prevent PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does early cognitive behavioural therapy reduce postpartum depression? Carta, G., D'Alfonso, A., Parisse, V., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Brief cognitive behavioral therapy in pregnant women at risk of postpartum depression: Pre-post therapy study in a city in southern Brazil. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

In-person 1-day cognitive behavioral therapy-based workshops for postpartum depression: a randomized controlled trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Public health nurse delivered group cognitive behavioral therapy (CBT) for postpartum depression: A pilot study. [2021]

6. Singapore pubmed.ncbi.nlm.nih.gov

How does early cognitive behavioural therapy reduce postpartum depression? [2020]