A Community Support Network Intervention in SOAR Project Intimate Partner Violence-Related Traumatic Brain Injury

NCT04890925 | Unknown

• 1 other identifier: H20-02412
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Intimate Partner Violence (IPV) comprises physical, sexual and emotional abuse and controlling behaviors imposed by an intimate partner. It is estimated that up to 92% of women who survive IPV may have suffered one or more traumatic brain injuries (TBI) from blows to the head, face, and neck, and/or anoxia or hypoxia due to strangulation. Even mild TBI may manifest as alternations in consciousness, black out, dizziness, disorientation, anxiety, depression, post-traumatic stress disorder, muscles weakness or paralysis and deficits in memory, attention, planning as well as executive functions. These signs and symptoms of TBI and their consequences impact the quality of life of women surviving IPV. Furthermore, survivors experiencing multiple IPV may acquire larger extent of the injury. Though this is recognized as an urgent and serious issue worldwide, it has been remarkably understudied. 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.

Conditions

Mild Traumatic Brain Injury

Keywords

Brain injury; Cognitive functions; Domestic violence; Intimate partner violence; Quality of life; Strangulation; Women

Outcome Measures

Primary Outcomes (2)

• Cambridge Brain Science tasks (Now called Creyos) for assessing change in neuroconginitve functions and Task Switching Task for assessing executive functions

  Two purposes. 1. To measure "change" from baseline at one month. 2. To measure intervention-induced change, immediately after intervention and at 6 months post intervention Assessments include 12 different tasks to measure short-term memory, response inhibition, attention, verbal reasoning, visuospatial working memory, deductive reasoning, episodic memory, visuospatial processing, mental rotation, planning, spatial short-term memory, and working memory. The detail on CBS tests are available online at https://cambridgebrainsciences.com. Some of the tasks have to be solved as quickly and accurately as possible, whereas others have to be solved only as accurately as possible. Neurocognitive functions are assessed in terms of accuracy (number of correct judgments) and efficiency (ratio between total judgments and correct judgments) and/or speed (number of judgments at all) for each subtest. Higher scores indicate higher performance in each task.

  The 1st and 2nd sessions (one month apart) will occur prior to the enrollment to the intervention, the 3rd within 3 days of completing the intervention, and the 4th, 6 months after completing the intervention.

• Connor-Davidson Resiliency Scale to measure change in resilience

  Two purposes. 1. To measure "change" from baseline at one month. 2. To measure intervention-induced change, immediately after intervention and at 6 months post intervention Resiliency will be characterized using the Connor-Davidson Resilience Scale. This 25-item self-rated questionnaire measures responses to five factors associated with resilience on a 5-point Likert scale as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The scale is rated based on how the participant has felt over the past month. The total score ranges from 0-100, with higher scores reflecting greater resilience. It has sound psychometric properties.

  The 1st and 2nd sessions (one month apart) will occur prior to the enrollment to the intervention, the 3rd within 3 days of completing the intervention, and the 4th, 6 months after completing the intervention.

Secondary Outcomes (1)

• Medical Outcomes study Questionnaire Short Form 36 (SF-36) to measure change in overall health status.

  The 1st and 2nd sessions (one month apart) will occur prior to the enrollment to the intervention, the 3rd within 3 days of completing the intervention, and the 4th, 6 months after completing the intervention.

Study Arms (3)

Control group

NO INTERVENTION

Women who have experienced intimate partner violence but no sustained brain injury (Brain Injury Severity Assessment; BISA = 0)

Community Support Network (CSN) intervention group

EXPERIMENTAL

The SOAR Community Support Network (CSN) intervention includes cognitive training, aerobic exercise, mindfulness meditation, counselling, quality of life tracking.

Behavioral: Community Support Network (CSN) intervention

Usual care

ACTIVE COMPARATOR

Participants in this group will receive dose-equivalent usual care

Behavioral: Usual care

Interventions

Community Support Network (CSN) intervention BEHAVIORAL

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.

Also known as: Behavioral training, Cognitive and physical training

Community Support Network (CSN) intervention group

Usual care BEHAVIORAL

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.

Usual care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who identify as women and are survivors of IPV-related TBI

You may not qualify if:

• Pregnancy; any diagnosed neurological disorder other than brain injury known to affect cerebrovascular, neurocognitive, and/or sensorimotor function (e.g., stroke, Parkinson's, Alzheimer's, cerebral palsy, multiple sclerosis, migraine, seizures, etc.); taking any medication that might alter your blood pressure; have an injury or illness which affects your joints like arthritis. Participants will be tested in the early follicular phase or, if on combined hormonal contraception, at the end of the week that is off this contraception.

Sponsors & Collaborators

• University of British Columbia: lead
• BrainTrust Canada: collaborator
• The Kelowna Women's Shelter: collaborator
• ABI Wellness: collaborator
• Nanaimo Brain Injury Society: collaborator

Study Sites (1)

Nanaimo Brain Injury Society

Nanaimo, British Columbia, V9R 3A3, Canada

RECRUITING

Related Publications (15)

• 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.

  PMID: 32567875 RESULT

• Colantonio A. Beyond Football: Intimate Partner Violence and Concussion/Brain Injury. Canadian Psychology. 2020.

  RESULT

• 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.

  PMID: 12924684 RESULT

• 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.

  PMID: 29873292 RESULT

• 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.

  PMID: 29292069 RESULT

• 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.

  PMID: 27766587 RESULT

• 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.

  PMID: 31442093 RESULT

• 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.

  PMID: 30535623 RESULT

• 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.

  PMID: 26176913 RESULT

• 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.

  PMID: 29294714 RESULT

• 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.

  PMID: 29157025 RESULT

• 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.

  PMID: 31771689 RESULT

• 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.

  PMID: 27792852 RESULT

• 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.

  PMID: 12964174 RESULT

• 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.

  PMID: 33201041 RESULT

MeSH Terms

Conditions

Brain Concussion; Brain Injuries

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kelsey Helm

  SOAR project at UBC

  STUDY DIRECTOR

Central Study Contacts

Shambhu P Adhikari, PhD

CONTACT

7785942164; shambhu.adhikri@ubc.ca

Paul van Donkelaar, PhD

CONTACT

2508633230; paul.vandonkelaar@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is an experimental design. A comparison with control group is made to evaluate time related changes. The intervention (Community Support Network) group will be compared with a group receiving usual care to investigate 6 months intervention-induced effect.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 18, 2021
• Study Start: May 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: May 30, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

CA (1)