Perinatal Dialectical Behavioural Therapy for Complex Pregnancies

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Minors, Psychologically unstable, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to adapt Dialectical Behavior Therapy (DBT) with Indigenous Knowledge to better support individuals with complex pregnancies. The goal is to enhance the therapy's meaning and accessibility, particularly for marginalized groups, through storytelling and cultural validation. Participants should be pregnant or up to 12 weeks postpartum and have control over their healthcare decisions. The trial seeks to include BIPOC individuals to ensure a culturally safe and anti-oppressive care environment. As an unphased study, this trial provides a unique opportunity to contribute to culturally inclusive mental health care.

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's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this therapy is safe for complex pregnancies?

Previous studies have shown that Dialectical Behavioural Therapy (DBT) helps improve mental health for pregnant women. Research indicates that DBT can reduce suicidal thoughts and other serious issues. It is often used for individuals with complex mental health needs.

Most people find DBT manageable, with few reports of harmful side effects, making it a safe option for those facing mental health challenges during pregnancy. However, results can vary, so discussing its suitability with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Modified Dialectical Behavioural Therapy (DBT) for complex pregnancies because it offers a tailored approach to managing the unique emotional and mental health challenges during this period. Unlike standard therapies that may not address the specific stressors and emotional fluctuations of pregnancy, this modified DBT incorporates strategies that focus on mindfulness, emotional regulation, and interpersonal effectiveness, all crucial for expecting mothers. This personalized approach aims to better support mental health and improve outcomes for both the mother and the baby, potentially reducing stress-related complications that can arise during complex pregnancies.

What evidence suggests that this modified Dialectical Behavioural Therapy is effective for complex pregnancies?

Research has shown that Dialectical Behavioural Therapy (DBT) can improve mental health during pregnancy and after childbirth. One study found that DBT skills groups significantly reduced stress and improved emotional management. Another review noted that DBT-based treatments appear promising for mental health issues during this period, though additional research would strengthen the evidence. While combining Indigenous Knowledge with DBT remains underexplored, focusing on individual needs and cultural sensitivity could enhance its effectiveness for marginalized groups. Overall, DBT has produced positive results in similar situations, suggesting potential benefits for those with complicated pregnancies. Participants in this trial will receive Modified Dialectical Behavioural Therapy to assess its effectiveness in complex pregnancies. ^{1 2 3 6 7}

Who Is on the Research Team?

Kellie Thiessen

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for marginalized individuals with complex psychosocial issues during pregnancy. It aims to provide culturally safe and anti-oppressive care, integrating Indigenous knowledge into therapy. Participants must be open to incorporating traditional beliefs into their treatment.

Inclusion Criteria

I make my own health care decisions.

I am currently pregnant or have given birth within the last 12 weeks.

We will prioritize a representative group of patients that include Black, Indigenous, People of Color (BIPOC) and represent the IPPC clinic population

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Modified Dialectical Behavioural Therapy co-delivered by an Indigenous Elder, a perinatal psychiatrist, and a social worker, integrating traditional practices and teachings.

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment through patient interviews and thematic analysis.

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Modified Dialectical Behavioural Therapy

Trial Overview The study tests a modified version of Dialectical Behaviour Therapy (DBT) co-led by an Indigenous Elder. The goal is to enrich the standard therapy with Indigenous storytelling and validation, tailored individually to enhance well-being in pregnancy.

How Is the Trial Designed?

Group I: Modified Dialectical Behavioural Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/cpp.2937

Applications of dialectical behavioural therapy in the ... This review highlights that few studies have shown DBT-informed interventions to be effective in improving a range of perinatal mental health ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7491613/

Perinatal mental health: a review of progress and challenges In this paper, we summarize and critically examine the epidemiology and impact of perinatal mental disorders, including emerging evidence of an increase of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11733485/

Perinatal emotional skills groups for women and birthing ... Perinatal ESGs may represent an effective intervention for perinatal women and birthing people with BPD. Their efficacy should be tested in a fully powered RCT.

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

Effectiveness of cognitive behavioural therapy-based ... CBT-based interventions for depression during the perinatal period appear effective, however results should be interpreted with caution.

5. cambridge.org cambridge.org/core/journals/behavioural-and-cognitive-psychotherapy/article/impact-of-including-babies-on-the-effectiveness-of-dialectical-behaviour-therapy-skills-groups-in-a-community-perinatal-service/4BF483EE1939B56D06CAFAF025577EF5

The impact of including babies on the effectiveness ... Results indicated that DBT skills groups significantly improved levels of psychological distress and emotional regulation. Conclusions:.

6. policycentermmh.org policycentermmh.org/maternal-suicide-issue-brief-2025/

Maternal Suicide in the U.S. - The Latest Data And ... Numerous research studies, including several randomized control trials, have shown DBT to be effective in reducing suicidal behavior and other ...

7. link.springer.com link.springer.com/article/10.1007/s00737-023-01313-4

Interventions for perinatal borderline personality disorder ... Results suggest an association between Dialectical Behavioural Therapy (DBT) group skills training, a multimodal therapeutic approach at a ...