Dialectical Behaviour TherapyNCT06466694
Pathways to Care-Understanding the Impact of an Indigenous Elder Co-lead in Perinatal Dialectical Behaviour Therapy
A study testing Modified Dialectical Behavioural Therapy in people with Dialectical Behaviour Therapy, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dialectical Behaviour Therapy
- What is being tested?
- Modified Dialectical Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Nursing, University of Manitoba
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: 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.
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
Read the 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.
- Conditions
- Dialectical Behaviour Therapy
- Being tested
- Modified Dialectical Behavioural Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Dialectical Behavioural TherapyBehavioural
The therapy will be co-delivered by the Elder, a perinatal psychiatrist and social worker trained in DBT. To evaluate through a patient lens content of the Dialectical Behavior Therapy (DBT) through the lens of an Indigenous Knowledge Carrier (Elder)
| Study group | Role | What they receive |
|---|---|---|
| Modified Dialectical Behavioural Therapy | Other | Not described Receives: Behavioral: Modified Dialectical Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes of Modified Dialectical Therapy on marginalized pregnant patients.
Outcomes of Modified Dialectical Therapy with patient interviews pre and post therapy using thematic analysis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start20 Feb 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialectical Behaviour TherapyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kellie Thiessen, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466694
- Sponsor's protocol ID
- HS26098 (H2023:234)
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06466694
- Acronym / sponsor ID
- HS26098 (H2023:234)
- Conditions
- Dialectical Behaviour Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Dialectical Behavioural Therapy | Other | Behavioral: Modified Dialectical Behavioural Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Dialectical Behavioural TherapyThe therapy will be co-delivered by the Elder, a perinatal psychiatrist and social worker trained in DBT. To evaluate through a patient lens content of the Dialectical Behavior Therapy (DBT) through the lens of an Indigenous Knowledge Carrier (Elder) | Behavioural | Modified Dialectical Behavioural Therapy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kellie Thiessen principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Dialectical Behavioural Therapy in people with Dialectical Behaviour Therapy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcomes of Modified Dialectical Therapy on marginalized pregnant patients. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.