A Community Support Network Intervention in SOAR Project Intimate Partner Violence-Related Traumatic Brain Injury
NCT ID: NCT04890925
Last Updated: 2023-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2022-05-01
2024-05-30
Brief Summary
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To improve the quality of life of women experiencing IPV-related TBI, and to prevent potential longer-term consequences, an evidence-based therapeutic treatment is an urgent need. The Supporting Survivors of Abuse and Brain Injury through Research (SOAR) Project at the University of British Columbia-Okanagan was designed to integrate TBI knowledge into community-based supports. This Michael Smith Foundation for Health Research (MSFHR) trainee application will focus on the evaluation of the effectiveness of a community support network intervention for women with IPV-related TBI. The outcomes will generate valuable evidence to inform potential new TBI-informed policies regarding community-based and health care supports for survivors of IPV.
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Detailed Description
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The very few studies conducted in this population have reported the prevalence of IPV-related TBI, characteristic signs and symptoms, prevalence and primary sequelae of non-fatal strangulation, and brain network organization associated with TBI and its cognitive effects. A recent randomized trial on prevention of IPV and relationship problems focused on the parents of newborns demonstrated that prevention interventions for at-risk couples were not effective and rather showed iatrogenic effects for some couples. Therefore, therapeutic treatment for IPV-related TBI survivors is crucial, and any physical or cognitive impairment in these survivors require therapeutic interventions similar to non-partner related TBIs.
Effective therapeutic interventions would not only improve IPV-related TBI survivors' quality of life but also has the potential to prevent longer-term neurodegeneration if early detection is possible and timely treatment is provided. However, women rarely receive any therapeutic assessment or interventions after sustaining IPV-related TBI due to the lack of awareness regarding early detection and need of therapeutic interventions. On the other hand, evidence-based therapeutic interventions to improve the quality of life of survivors of IPV-related TBI are still lacking.
The Supporting Survivors of Abuse and Brain Injury through Research (SOAR) Project at UBC-Okanagan is a multidisciplinary, community-based partnership designed to i) investigate the incidence and characteristics of IPV-related TBI; ii) use integrated knowledge translation to co-create and disseminate knowledge products designed to increase knowledge and awareness of TBI in those who provide support for IPV survivors; and iii) evaluate the effectiveness of a community support network intervention for women with IPV-related TBI. This MSFHR trainee application will focus on this last aim.
This project will characterize quality of life, resilience, and neurocognitive and sensorimotor function prior to, immediately after, and 6 months after a 6-month community-based intervention incorporating executive function, physical activity, mindfulness/meditation, and health counseling components by comparing with a group receiving usual care and control participants. In addition, exploratory analyses will demonstrate the response to the intervention depending upon the severity of the IPV-related TBI, whether strangulation was part of the experience or not, and the extent of psychopathological comorbidities (e.g., post traumatic stress disorders, anxiety, depression, adverse childhood experiences, etc.).
This study aims to disseminate the findings not only through conference presentations and peer-reviewed journal publications but also through ongoing engagement with our local, regional, and national community partner organizations. We have already co-developed and implemented a knowledge product - the Women's Support Workers module of the Concussion Awareness Training Tool (CATT) to help raise knowledge and awareness of brain injury in those who provide support to survivors of IPV. We would envision incorporating some of the key takeaway findings from the SOAR project into an updated version of the CATT module.
The expected outcomes of this study will add strong evidence to the effectiveness of therapeutic interventions for, and strengthen our understanding of, this understudied experience. More broadly, this study will (i) enhance professional knowledge and research skills in understanding this underserved population, (ii) build up research knowledge on this topic, and (iii) increase knowledge on the efficacy of a novel intervention. Thus, clearly and objectively characterizing the potential for a community support network to improve resiliency, quality of life, and neurocognition will have far-reaching implications for social support policy and funding for this population and their caregivers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
Women who have experienced intimate partner violence but no sustained brain injury (Brain Injury Severity Assessment; BISA = 0)
No interventions assigned to this group
Community Support Network (CSN) intervention group
The SOAR Community Support Network (CSN) intervention includes cognitive training, aerobic exercise, mindfulness meditation, counselling, quality of life tracking.
Community Support Network (CSN) intervention
The SOAR Community Support Network (CSN) intervention is a multi-pillar, interdisciplinary system platform focused on improving higher order cognitive functions through aerobic exercise, mindfulness meditation, counselling, quality of life tracking, and cognitive exercises. The goal is to improve cognitive functions such as executive function, reasoning, and memory among those experiencing the effects of brain injury. Individually tailored protocol is administered to each participant. Goals are set daily, weekly, and monthly, and accomplishments tracked in a database. The CSN seeks to test and evaluate the success of the program when applied, and tailored, to survivors of brain injury in intimate partner violence.
Usual care
Participants in this group will receive dose-equivalent usual care
Usual care
Participants in this group will receive dose-equivalent usual care based on the findings of a recent survey of the Canadian Rehabilitation Clinicians for concussion management, scoping review and clinical studies. Based on the evidence, usual care in this study will consist of education and aerobic exercises. Education includes information about the injury, recovery, management, nutrition, hydration, sleep, reassurance and goal setting that will be adapted to make appropriate to the population of this study. Aerobics include stationary cycling and treadmill exercises.
Interventions
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Community Support Network (CSN) intervention
The SOAR Community Support Network (CSN) intervention is a multi-pillar, interdisciplinary system platform focused on improving higher order cognitive functions through aerobic exercise, mindfulness meditation, counselling, quality of life tracking, and cognitive exercises. The goal is to improve cognitive functions such as executive function, reasoning, and memory among those experiencing the effects of brain injury. Individually tailored protocol is administered to each participant. Goals are set daily, weekly, and monthly, and accomplishments tracked in a database. The CSN seeks to test and evaluate the success of the program when applied, and tailored, to survivors of brain injury in intimate partner violence.
Usual care
Participants in this group will receive dose-equivalent usual care based on the findings of a recent survey of the Canadian Rehabilitation Clinicians for concussion management, scoping review and clinical studies. Based on the evidence, usual care in this study will consist of education and aerobic exercises. Education includes information about the injury, recovery, management, nutrition, hydration, sleep, reassurance and goal setting that will be adapted to make appropriate to the population of this study. Aerobics include stationary cycling and treadmill exercises.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
FEMALE
Yes
Sponsors
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BrainTrust Canada
UNKNOWN
The Kelowna Women's Shelter
UNKNOWN
ABI Wellness
UNKNOWN
Nanaimo Brain Injury Society
UNKNOWN
University of British Columbia
OTHER
Responsible Party
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Paul van Donkelaar
Professor
Principal Investigators
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Kelsey Helm
Role: STUDY_DIRECTOR
SOAR project at UBC
Locations
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Nanaimo Brain Injury Society
Nanaimo, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Buttell F, Ferreira RJ. The hidden disaster of COVID-19: Intimate partner violence. Psychol Trauma. 2020 Aug;12(S1):S197-S198. doi: 10.1037/tra0000646. Epub 2020 Jun 22.
Colantonio A. Beyond Football: Intimate Partner Violence and Concussion/Brain Injury. Canadian Psychology. 2020.
Valera EM, Berenbaum H. Brain injury in battered women. J Consult Clin Psychol. 2003 Aug;71(4):797-804. doi: 10.1037/0022-006x.71.4.797.
Valera EM, Cao A, Pasternak O, Shenton ME, Kubicki M, Makris N, Adra N. White Matter Correlates of Mild Traumatic Brain Injuries in Women Subjected to Intimate-Partner Violence: A Preliminary Study. J Neurotrauma. 2019 Mar 1;36(5):661-668. doi: 10.1089/neu.2018.5734. Epub 2018 Oct 4.
Patch M, Anderson JC, Campbell JC. Injuries of Women Surviving Intimate Partner Strangulation and Subsequent Emergency Health Care Seeking: An Integrative Evidence Review. J Emerg Nurs. 2018 Jul;44(4):384-393. doi: 10.1016/j.jen.2017.12.001. Epub 2017 Dec 30.
Valera E, Kucyi A. Brain injury in women experiencing intimate partner-violence: neural mechanistic evidence of an "invisible" trauma. Brain Imaging Behav. 2017 Dec;11(6):1664-1677. doi: 10.1007/s11682-016-9643-1.
Smirl JD, Jones KE, Copeland P, Khatra O, Taylor EH, Van Donkelaar P. Characterizing symptoms of traumatic brain injury in survivors of intimate partner violence. Brain Inj. 2019;33(12):1529-1538. doi: 10.1080/02699052.2019.1658129. Epub 2019 Aug 23.
Heyman RE, Slep AMS, Lorber MF, Mitnick DM, Xu S, Baucom KJW, Halford WK, Niolon PH. A Randomized, Controlled Trial of the Impact of the Couple CARE for Parents of Newborns Program on the Prevention of Intimate Partner Violence and Relationship Problems. Prev Sci. 2019 Jul;20(5):620-631. doi: 10.1007/s11121-018-0961-y.
Kondo A, Shahpasand K, Mannix R, Qiu J, Moncaster J, Chen CH, Yao Y, Lin YM, Driver JA, Sun Y, Wei S, Luo ML, Albayram O, Huang P, Rotenberg A, Ryo A, Goldstein LE, Pascual-Leone A, McKee AC, Meehan W, Zhou XZ, Lu KP. Antibody against early driver of neurodegeneration cis P-tau blocks brain injury and tauopathy. Nature. 2015 Jul 23;523(7561):431-436. doi: 10.1038/nature14658. Epub 2015 Jul 15.
Iverson KM, Sayer NA, Meterko M, Stolzmann K, Suri P, Gormley K, Nealon Seibert M, Yan K, Pogoda TK. Intimate Partner Violence Among Female OEF/OIF/OND Veterans Who Were Evaluated for Traumatic Brain Injury in the Veterans Health Administration: A Preliminary Investigation. J Interpers Violence. 2020 Jul;35(13-14):2422-2445. doi: 10.1177/0886260517702491. Epub 2017 Apr 18.
Dobney DM, Miller MB, Tufts E. Non-pharmacological rehabilitation interventions for concussion in children: a scoping review. Disabil Rehabil. 2019 Mar;41(6):727-739. doi: 10.1080/09638288.2017.1400595. Epub 2017 Nov 20.
Varner CE. Specialized concussion clinic referrals are not intended for all acute concussion patients in the emergency department. CJEM. 2019 Nov;21(6):694-697. doi: 10.1017/cem.2019.430. No abstract available.
Varner CE, McLeod S, Nahiddi N, Lougheed RE, Dear TE, Borgundvaag B. Cognitive Rest and Graduated Return to Usual Activities Versus Usual Care for Mild Traumatic Brain Injury: A Randomized Controlled Trial of Emergency Department Discharge Instructions. Acad Emerg Med. 2017 Jan;24(1):75-82. doi: 10.1111/acem.13073.
Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
Teel E, Brossard-Racine M, Corbin-Berrigan LA, Gagnon I. Perceptual Cognitive Training Does Not Improve Clinical Outcomes at 4 and 12 Weeks Following Concussion in Children and Adolescents: A Randomized Controlled Trial. J Head Trauma Rehabil. 2021 Mar-Apr 01;36(2):E97-E107. doi: 10.1097/HTR.0000000000000633.
Other Identifiers
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H20-02412
Identifier Type: -
Identifier Source: org_study_id
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