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Clinical Trials/NCT06466694
NCT06466694Active, not recruitingNot Applicable

Pathways to Care-Understanding the Impact of an Indigenous Elder Co-lead in Perinatal Dialectical Behaviour Therapy (DBT) Skills Sessions in Pregnant Persons With Complex Care Needs.

University of Manitoba2 sites in 1 country48 target enrollmentStarted: February 20, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
48
Locations
2
Primary Endpoint
Outcomes of Modified Dialectical Therapy on marginalized pregnant patients.

Study Overview

Brief Summary

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

Detailed Description

Dialectical Behavior Therapy (DBT) is considered gold-standard therapy for individuals with borderline personality, and increasingly first line for addictions, coping deficits, and social instability. Participants will be asked to evaluate the integration of an Indigenous Knowledge Carrier (Elder) into a DBT program at an inner-city prenatal clinic. Patients will be pregnant or newly postpartum and qualify for DBT for routine mental health or substance associated indications. Therapy offerings will be customized to include traditional practices (ie: smudging, meditation) and teachings (ie: medicine wheel, 7 Sacred Teachings) along with standard, evidence-based content. The therapy will be co-delivered by the Elder, a perinatal psychiatrist and social worker trained in DBT. Evaluation of this modified program will be voluntary. The pre-interview guide is guided by an Appreciative Inquiry lens. The post-interview guide will be developed after analysis of the content from the pre-interview guide. Appreciative Inquiry is a qualitative research method which focuses on a strengths-based approach. The investigators will thematically analyze the data from the pre/post interviews into the predefined five stages of Appreciative Inquiry.

The investigators will utilize the Methods for Patient and Public Engagement Guide to map our research stage, level, and method of engagement. These stages include preparing for execution, data collection, data analysis, dissemination, implementation, and evaluation. Within each of these stages there are various engagement levels (consult, collaborate and partner representative) and then various methods of engagement (appreciative inquiry, discussion groups, consultations etc.) With this stepwise approach, the investigators will identify outcomes-measures that are meaningful to the population served via patient feedback.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients who have their own agency and decision-making power over their health care.
  • Patients may be antepartum or up to 12 weeks postpartum at the time of patient invitation.
  • We will not engage minors.
  • We will not engage a patient who is psychologically or physically unstable.
  • We will prioritize a representative group of patients that include Black, Indigenous, People of Color (BIPOC) and represent the IPPC clinic population.
  • Exclusion criteria:
  • Patients who are minors or who are psychologically or physically unstable.
  • Our team of clinicians will screen patients prior to any initiation of engagement with these inclusion criteria as our guide, and a Pledge of Confidentiality will be obtained.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Outcomes of Modified Dialectical Therapy on marginalized pregnant patients.

Time Frame: 1 year

Outcomes of Modified Dialectical Therapy with patient interviews pre and post therapy using thematic analysis.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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