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

May 19, 2023 updated by: Paul van Donkelaar, University of British Columbia

Evaluating The Effectiveness Of A Community Support Network Intervention For

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Globally, about 35% of women experience intimate partner violence (IPV) over the course of their lives. The COVID-19 pandemic has resulted in a rapid increase of the incidence of IPV as vulnerable women are more likely to be trapped at home with their abusers. In Canada, IPV affects one in four women over their lifetime. In a study conducted in the United States, a heterogeneous (with respect to race, age, education level and employment status) sample of 99 community and shelter women, showed that about 75% sustained at least one IPV-related traumatic brain injury (TBI) and 50% of women sustained multiple IPV-related TBIs. Similar to post-concussive signs and symptoms, women with IPV-related TBI demonstrate cognitive impairments (e.g., deficits in memory, attention, reasoning, planning and executive functioning), psychopathological problems (such as depression, anxiety, fatigue and post-traumatic stress disorders), and/or sensorimotor problems (such as paralysis or paresis of facial or extremity muscles, numbness, loss of sensation, muscle spasms, facial droop, and unilateral weakness), due to blows to the head, face, or neck and/or strangulation which ultimately impacts quality of life.

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.

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Nanaimo, British Columbia, Canada, V9R 3A3
        • Recruiting
        • Nanaimo Brain Injury Society
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Other Names:
  • Behavioral training
  • Cognitive and physical training
Active Comparator: Usual care
Participants in this group will receive dose-equivalent usual care
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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.

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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Outcomes study Questionnaire Short Form 36 (SF-36) to measure change in overall health status.
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.

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

Quality of Life will be measured using a modified version of the SF-36. This 36-item questionnaire consists of 8-scaled scores covering several aspects of quality of life and general health. The SF-36 has eight scaled (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, and Mental health) scores. The scores are weighted sums of the questions in each section. Scores range from 0 - 100; with lower scores indicating more disability and higher scores indicating less disability. The SF-36 is a reliable and well validated tool.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

BrainTrust Canada
ABI Wellness
The Kelowna Women's Shelter
Nanaimo Brain Injury Society

Investigators

  • Study Director: Kelsey Helm, SOAR project at UBC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

May 30, 2024

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H20-02412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There is a plan to make individual participant data available to other researchers. However, it has not been finalized.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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