Evaluating the Integration of Indigenous Healing With Principals of Seeking Safety for Treatment of Indigenous Patients With a History of Trauma and Active Substance Use Disorder.
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| ClinicalTrials.gov Identifier: NCT04604574 |
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Recruitment Status :
Completed
First Posted : October 27, 2020
Last Update Posted : October 27, 2020
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Background: The negative health outcomes experienced by Indigenous peoples may be understood as direct consequences of colonization. One of the key consequences of the colonial influence on Canada's Indigenous peoples has been intergenerational trauma (IGT). Indigenous communities in Canada face significant challenges with IGT, which often manifest in substance use disorders (SUD). Indigenous communities have identified SUD as one of their greatest health challenges(Maté 2009), with some Northern Ontario First Nations communities experiencing SUD rates of 70% (Calveson 2010). Most Elders, traditional healers, and Indigenous scholars agree that connecting treatment to culture, land, community, and spiritual practices is a pathway to healing trauma and SUD for Indigenous peoples. Recent work by Dr. Teresa Naseba Marsh has demonstrated that Indigenous Healing and Seeking Safety (IHSS) model for trauma therapy can be effectively combined for the treatment of Indigenous patients with a history of trauma and SUD. Seeking Safety incorporates the inclusion of the mind, body, spirit, and self-awareness during treatment, and the perspective of Seeking Safety is convergent with traditional Indigenous healing methods. Benbowopka Treatment Centre is a residential treatment site operated by Mamaweswen, located in the North Shore Tribal Council in Blind River, Ontario. Benbowopka's mandate is to provide treatment for Indigenous clients with trauma and SUD. They are also implementing a culturally sensitive program grounded in IHSS methodology for the treatment of Indigenous patients' trauma and SUD. Through our current collaboration with Benbowopka and Mamaweswen the applicants have collected baseline data from client files to establish historical outcomes going back three years. In 2016, we began the collaborative implementation of the Indigenous Healing and Seeking Safety (IHSS) model for trauma therapy for clients at Benbowopka.
Objective: The purpose of this proposal is to evaluate the effectiveness of the IHSS intervention which blends Indigenous Healing Practices and a mainstream treatment model, Seeking Safety for the treatment of Indigenous patients with a history of trauma and SUD. Methodology: In collaboration with the North Shore Tribal Council and the Benbowopka Treatment Center, we propose a prospective evaluation of IHSS treatment for Indigenous patients with a history of trauma and SUD. Benbowopka treats approximately 90 patients per year in a residential treatment program, and the program has high quality retrospective data on their programming and outcomes. We propose to benchmark anonymized historical program outcomes by evaluating program outcomes and the impact of program completion on health systems usage. Impact of treatment on health system usage will be determined by linking anonymized patient records with records at the Institute for Clinical and Evaluative Sciences (ICES). ICES linkage will provide further insight into hospitalizations, interaction with emergency, mental health, and primary care usage before and following the implementation of the IHSS intervention. We will respect the Tricouncil Policy Statement, Chapter 9, which highlights the importance of engaging with First Nations throughout all phases of the research process. In addition, we will honour Indigenous knowledge by engaging with Elders and the North Shore Tribal council. Through the data governance protocols established at ICES, we will respect the First Nations principles of ownership, control, access and possession of data (OCAP™). Dr. Jennifer Walker Canada Research Chair in Indigenous Health at the Center for Rural and Northern Health Research and ICES Scientist will oversee the process of data sharing and linking de-identified Benbowopka treatment data to anonymized health system data at ICES. Benbowopka and the North Shore Tribal council will maintain complete ownership over the study data and its subsequent dissemination. Anticipated Outcome: We expect that patients who are treated in the IHSS treatment model will have improved outcomes as compared to previous patients of Benbowopka treated under the abstinence based model of therapy. Objectives measures will include treatment completion, substance use at program completion, substance use at follow-up, ED visits, hospitalization, and death. Patient satisfaction will be tracked using surveys administered at treatment completion and is expected to improve with implementation of IHSS. Impact: We expect to demonstrate that the IHSS is a culturally sensitive and effective treatment model for Indigenous patients who are affected by trauma and substance use disorder.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Substance Use Disorders Post-Traumatic Stress Disorder Intergenerational Trauma | Other: Indigenous Healing and Seeking Safety | Not Applicable |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 550 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | We plan to conduct a pre/post intervention matched comparison group study. We will compare historical treatment outcomes for past Benbowopka patients to outcomes following IHSS treatment for Indigenous patients with a history of trauma and SUD. All patient data will be anonymized at the time of data entry. Propensity matching will be undertaken for patient characteristics, including sex/gender, age, and substance use type. The National Native Alcohol and Drug Abuse Program (NNADAP) tool will be used to analyze the program objective; that is, whether completion rates improve following the implementation of the IHSS intervention. Additionally, a Client Quality Assurance Survey (attached) will be utilized to determine patient satisfaction. |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Evaluating the Integration of Indigenous Healing With Principals of Seeking Safety for Treatment of Indigenous Patients With a History of Trauma and Active Substance Use Disorder. |
| Actual Study Start Date : | January 1, 2018 |
| Actual Primary Completion Date : | March 31, 2020 |
| Actual Study Completion Date : | March 31, 2020 |
| Arm | Intervention/treatment |
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Pre/Post-Intervention
Patients who receive the novel IHSS intervention will be compared to historical controls who received the abstinence-based treatment model.
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Other: Indigenous Healing and Seeking Safety
Indigenous Healing and Seeking Safety Intervention: Initial 90-minute meetings will be conducted with the participants; during these meetings, participants will receive information about IHSS, traditional healing, sharing circles, sweat lodge ceremonies, and program details. The sharing circles will take place at Benbowopka Residential treatment Centre in Blind River, Ontario. Each of the sharing circles will be cofacilitated by two Indigenous health-care workers. These facilitators will organize and lead sharing circles daily throughout the 28-day treatment cycle. Each sharing circle will be two hours long. The Seeking Safety program consists of up to 25 treatment topics that aim to teach participants a variety of skills. The majority of topics address the cognitive, behavioral, interpersonal, and case management needs of persons with SUD and posttraumatic stress disorders (PTSD) (Najavits, 2002a). The treatment will adhere to the concept of Two-Eyed Seeing and cultural sensitivity.
Other Name: Abstinence-Based Treatment Historical Control |
- the patient perspective [ Time Frame: 28 days ]we will use Client Quality Assurance Survey tool to assess the appropriateness and satisfaction of the intervention.
- the program perspective [ Time Frame: 28 days ]we will use the structured assessments at admission to characterize changes in the patient population and the program completion rate as primary outcome to assess the effectiveness of the IHSS intervention
- the community perspective [ Time Frame: One Year ]Change in substance use related health system usage (number of Emergency room presentation and number of acute care admissions for substance use related conditions) between the year prior and the year following treatment completion as an indication of the impact of the admission on health system outcomes.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Substance Use Disorder
- Intergenerational Trauma
Exclusion Criteria:
- Inability to provide informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604574
| Canada, Ontario | |
| Northern Ontario School of Medicine | |
| Sudbury, Ontario, Canada, P3E2C6 | |
| Principal Investigator: | David C Marsh, MD | Northern Ontario School of Medicine |
| Responsible Party: | Health Sciences North Research Institute |
| ClinicalTrials.gov Identifier: | NCT04604574 |
| Other Study ID Numbers: |
6010991 |
| First Posted: | October 27, 2020 Key Record Dates |
| Last Update Posted: | October 27, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Indigenous Health Seeking Safety Health Care Utilization Residential Addiction Treatment |
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Disease Substance-Related Disorders Wounds and Injuries Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Historical Trauma |
Pathologic Processes Trauma and Stressor Related Disorders Mental Disorders Chemically-Induced Disorders Psychological Trauma |

