Recruiting

Community Support Network

Sponsor:

University of British Columbia

Code:

NCT04890925

Conditions

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Community Support Network (CSN) intervention

Usual care

Study Details

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

Study ID

NCT04890925

Start date

May 1, 2022

Status verified date

May, 2023

Completion date

May 30, 2024

Anticipated

Primary completion date

Dec 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control group

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

experimental: 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.

active comparator: Usual care

Participants in this group will receive dose-equivalent usual care

Interventions

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.

Primary outcome measure

  • Cambridge Brain Science tasks (Now called Creyos) for assessing change in neuroconginitve functions and Task Switching Task for assessing executive functions [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Shambhu P Adhikari, PhD

7785942164shambhu.adhikri@ubc.ca

Locations

Nanaimo Brain Injury Society

Recruiting

Nanaimo, British Columbia, Canada, V9R 3A3

Contacts

Kix Citton

ed@nbis.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 23, 2023

Last verified

May, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-05-23.