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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 9-week online group therapy called Cognitive Behavioral Therapy (CBT) can more effectively treat postpartum depression (PPD) when added to regular care. It also examines how CBT might improve related issues such as anxiety, parenting stress, and the mother-infant relationship. The trial targets mothers or birthing parents with postpartum depression who have infants under 12 months old and reside in Ontario, Canada. Participants will either join an online CBT group led by a nurse and a PPD survivor or continue with their usual care. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance postpartum care for many.

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 prior data suggests that this therapy is safe for postpartum depression?

Research has shown that Cognitive Behavioral Therapy (CBT), even when conducted online, is generally safe for those dealing with postpartum depression (PPD). Studies have found that CBT is well-tolerated and can effectively reduce symptoms of PPD, with most participants not experiencing serious side effects.

Several research studies have examined online CBT. For instance, one study found that online CBT for postpartum depression can be as effective as in-person sessions. The safety of online CBT is high, with very few reports of negative reactions, making it a low-risk option for many new mothers facing postpartum challenges.

In summary, CBT for postpartum depression, particularly online, has proven to be a safe and helpful approach for many individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for Postpartum Depression (PPD) because it's delivered online, making it more accessible for new mothers who might struggle to attend in-person sessions. Unlike traditional treatments that often rely solely on medication or face-to-face therapy, this approach includes support from a peer who has recovered from PPD, providing a relatable and empathetic perspective. This combination of professional guidance and peer support aims to create a supportive community, reducing feelings of isolation and potentially improving outcomes for mothers experiencing PPD.

What evidence suggests that Cognitive Behavioral Therapy might be an effective treatment for postpartum depression?

Research has shown that Cognitive Behavioral Therapy (CBT) effectively treats postpartum depression (PPD). Studies have found that CBT reduces depression and anxiety in new mothers. In this trial, participants in the "Online CBT Group" arm will attend a 9-week online CBT group co-led by a Public Health Nurse and a Peer. One study with 403 mothers demonstrated that online CBT workshops significantly improved PPD symptoms. Another study found that group CBT sessions led by public health nurses effectively treat PPD. This suggests that CBT, especially in a supportive group setting, can greatly benefit those dealing with PPD. ^{3 6 7 8 9}

Who Is on the Research Team?

Ryan Van Lieshout, MD, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Niagara Region Public Health

Collaborator

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

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Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

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Effectiveness of cognitive behavioural therapy-based ... Although existing evidence suggests cognitive behavioral therapy (CBT) based interventions are effective for perinatal depression, less is known ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735822000149

Effectiveness of cognitive behavioral therapy for perinatal ... Overall, CBT is effective for perinatal maternal depression, anxiety and stress. · CBT-only is effective for perinatal depression in low-income women. · Partner- ...

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Public Health Nurse-delivered Group Cognitive ... To examine the effectiveness of group cognitive behavioural therapy (CBT) for postpartum depression (PPD) delivered by public health nurses with little to ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2784108

Effect of Online 1-Day Cognitive Behavioral Therapy ... In this randomized clinical trial of 403 mothers, online 1-day CBT-based workshops led to clinically and statistically significant improvements in PPD and ...

6. formative.jmir.org formative.jmir.org/2022/9/e37216

Transdiagnostic Internet-Delivered Cognitive Behavioral ... Background: Postpartum depression (PPD) and postpartum anxiety (PPA) are often comorbid and are associated with significant personal and ...

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A Blended Cognitive–Behavioral Intervention for the ... The present article describes the application of Be a Mom Coping with Depression, a blended CBT treatment for postpartum depression, for a 31-year-old ...

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The Effects of Online Cognitive Behavioral Therapy on ... Background/Objectives: Postpartum depression seriously affects the safety and health of mothers and children. Online cognitive behavioral therapy is ...

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Effectiveness of cognitive behavioural therapy-based ... Although existing evidence suggests cognitive behavioral therapy (CBT) based interventions are effective for perinatal depression, less is known ...