Cognitive Behavioural Therapy for Postpartum Depression

Overseen By Ryan 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)

Compensation: Varies

Number of Visits: 9

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether online group cognitive behavioral therapy (CBT) can improve how babies manage their emotions when their mothers have postpartum depression (PPD). The study compares mothers receiving CBT alongside their usual care to those continuing only with their usual postnatal care. It is open to women in Ontario with symptoms of postpartum depression and an infant aged 4-12 months. Participants will join a 9-week online CBT group while continuing any existing healthcare.

As an unphased trial, this study offers mothers a unique opportunity to access innovative support that could enhance emotional well-being for both themselves and their babies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems like you can continue your usual treatment while participating in the study.

What prior data suggests that group cognitive behavioral therapy (CBT) is safe for postpartum depression?

Research has shown that group cognitive behavioral therapy (CBT) is generally safe for treating postpartum depression (PPD). Participants usually handle CBT well, according to studies. One study noted that even online CBT effectively helps mothers with PPD without causing major side effects. Another study recommended CBT as a first choice for many women with PPD, highlighting its safety and effectiveness. Most participants reported positive experiences and improvements in their mental health, with very few negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using group Cognitive Behavioural Therapy (CBT) for postpartum depression because it offers a unique approach compared to typical treatments like medication or individual therapy. This treatment is delivered online over nine weeks, making it more accessible to new mothers who might find it difficult to attend in-person sessions. Additionally, the group setting provides peer support, which can enhance the therapeutic experience by allowing participants to share experiences and strategies in a collaborative environment. This method aims to provide effective relief for postpartum depression while being convenient and supportive.

What evidence suggests that group CBT is effective for postpartum depression?

Research has shown that Cognitive Behavioral Therapy (CBT) effectively treats postpartum depression (PPD). Studies have found that CBT reduces depression in new mothers. In this trial, participants in the treatment arm will undergo a 9-week online group CBT intervention, which is convenient and fits into busy schedules. One study found that group CBT for PPD improves mood and overall well-being. This therapy works by changing negative thoughts and behaviors, leading to better mental health. Overall, evidence supports CBT as a powerful tool for managing PPD. ^{1 2 4 6 7}

Who Is on the Research Team?

Ryan Van Lieshout, MD, PhD

Principal Investigator

Mcmaster

Are You a Good Fit for This Trial?

This trial is for English-speaking women over 18 living in Ontario with postpartum depression, as indicated by an EPDS score of at least 10. Their infants should be aged between 4-8 months. Women with bipolar disorder, current psychotic disorders, substance abuse issues, or certain personality disorders cannot participate.

Inclusion Criteria

Have an EPDS score of 10 or more

Live in Ontario (the primary WHCC catchment area)

I am a woman aged 18 or older.

Exclusion Criteria

Current psychotic disorder

History of antisocial or borderline personality disorder.

History of substance or alcohol use 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 for Postpartum Depression (PPD) delivered via Zoom

9 weeks

9 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of maternal anxiety, infant temperament, and emotion regulation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Group Cognitive Behavioural Therapy (CBT)

Trial Overview The study tests if adding online group cognitive behavioral therapy (CBT) to the usual treatment helps improve how babies manage their emotions better than just the usual treatment alone. The effects will be checked right after and six months post-treatment.

How Is the Trial Designed?

Group I: Treatment (9-week online CBT group) Experimental Treatment 1 Intervention

Participants assigned to the treatment group will continue to receive any healthcare they might already be receiving (e.g. family doctor, midwife, Obstetrician/Gynecologist, etc.) and participate in a 9-week group Cognitive Behavioral Therapy (CBT) intervention for Postpartum Depression (PPD) delivered via Zoom by two trained psychologists, social workers, nurses, and/or psychiatrists.

Group II: Control (treatment as usual) Active Control 1 Intervention

The control group will receive standard postnatal care from their obstetrician, midwife, and/or family physician

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) is effective in reducing perinatal maternal depression, anxiety, and stress, with significant improvements observed both immediately after treatment and in the long term, based on a meta-analysis of 79 studies.

CBT alone showed strong short-term effects for perinatal anxiety and stress, and long-term benefits for depression and anxiety, indicating its versatility and effectiveness across different treatment modalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavioral therapy for perinatal maternal depression, anxiety and stress: A systematic review and meta-analysis of randomized controlled trials. Li, X., Laplante, DP., Paquin, V., et al.[2022]

In a study of 34 women with perinatal depression, 80% experienced significant improvement in their depressive symptoms after participating in a 9-week group cognitive behavioral therapy (CBT) program.

The group CBT also led to meaningful improvements in social support, mother-infant bonding, and partner relationship quality, suggesting it is an effective and resource-efficient treatment option for women with perinatal depression and psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of a brief group cognitive behavioural therapy intervention for perinatal depression. Van Lieshout, RJ., Yang, L., Haber, E., et al.[2019]

Group support based on cognitive behavioral therapy (CBT) for postnatally depressed mothers significantly improved their self-esteem and self-worth.

This approach addresses barriers to treatment, potentially reducing high dropout rates seen in traditional group or clinic-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovation:CBT-based support groups for postnatal depression. Alexander, P.[2018]

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 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]

Citations

1. samhsa.gov samhsa.gov/

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9152236/

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 ...

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- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11989130/

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 ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-04547-9

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

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666915321001219

Group cognitive-behavioural therapy for perinatal anxiety ... Background: Anxiety disorders are common during the perinatal period (pregnancy and up to 12 months postpartum) and may have a negative impact on maternal, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03285139

NCT03285139 | Peer Administered CBT for PPD Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line ...