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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

To integrate traditional Indigenous Knowledge with gold-standard therapy to enrich the patient experience from an anti-oppressive, culturally safe perspective for marginalized individuals with psychosocially complex pregnancies. The Knowledge Carrier does not have a prescribed way of integrating Indigenous knowledge but will respond to each patient on an individual basis depending on the needs in the current session, supporting the patients with story-telling and validation of Indigenous beliefs regarding well-being in pregnancy. Specific Aim 1: To evaluate through a patient lens content of the Dialectical Behavior Therapy (DBT) through the lens of an Indigenous Knowledge Carrier (Elder) to make content more rich and accessible to marginalized persons. Specific Aim 2: To provide a culturally safe space and anti-oppressive care environment for both Indigenous and non-Indigenous patients in keeping with the Truth and Reconciliation Call to Action #22

Research Team

Kellie Thiessen

Principal Investigator

University of Manitoba

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+