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Community Support Network Intervention for Traumatic Brain Injury (SOAR-CSNI Trial)
N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
SOAR-CSNI Trial Summary
This trial aims to improve the quality of life for women experiencing IPV-related TBI by creating evidence-based treatments and informing new policies to help survivors.
Who is the study for?
This trial is for women who have experienced traumatic brain injuries (TBI) due to intimate partner violence (IPV). They should not be pregnant, have other neurological disorders like stroke or Alzheimer's, take medication affecting blood pressure, or have joint-affecting conditions like arthritis.Check my eligibility
What is being tested?
The study tests a Community Support Network (CSN) intervention against usual care for women with IPV-related TBI. It aims to integrate TBI knowledge into community support and improve survivors' quality of life.See study design
What are the potential side effects?
Since the interventions involve non-medical community support and standard care practices, there are no direct medical side effects associated with this trial.
SOAR-CSNI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cambridge Brain Science tasks (Now called Creyos) for assessing change in neuroconginitve functions and Task Switching Task for assessing executive functions
Connor-Davidson Resiliency Scale to measure change in resilience
Secondary outcome measures
Medical Outcomes study Questionnaire Short Form 36 (SF-36) to measure change in overall health status.
SOAR-CSNI Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Community Support Network (CSN) intervention groupExperimental Treatment1 Intervention
The SOAR Community Support Network (CSN) intervention includes cognitive training, aerobic exercise, mindfulness meditation, counselling, quality of life tracking.
Group II: Control groupActive Control1 Intervention
Women who have experienced intimate partner violence but no sustained brain injury (Brain Injury Severity Assessment; BISA = 0)
Group III: Usual careActive Control1 Intervention
Participants in this group will receive dose-equivalent usual care
Find a Location
Who is running the clinical trial?
Kelowna Women's ShelterUNKNOWN
Nanaimo Brain Injury SocietyUNKNOWN
The Kelowna Women's ShelterUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication that could affect my blood pressure.I have a condition like arthritis affecting my joints.I have a neurological condition affecting my brain function, other than brain injury.I am a woman who has survived brain injury due to intimate partner violence.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Community Support Network (CSN) intervention group
- Group 3: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this medical experiment limited to those under the age of 55?
"As outlined in the inclusion criteria, only those aged 18 to 50 years old are eligible for this clinical trial."
Answered by AI
What criteria must an individual satisfy to qualify for participation in this investigation?
"This clinical trial is accepting applications from individuals aged 18 to 50 with a concussion. At this time, 78 patients are estimated to enroll in the study."
Answered by AI
Are participants being enrolled for this research endeavor at present?
"Clinicaltrials.gov indicates that this investigation is actively seeking participants, having been listed since May 1st 2022 and last revised on May 19th 2023."
Answered by AI
How many volunteers are taking part in this medical experiment?
"Affirmative, the information on clinicaltrials.gov affirms that this medical examination is actively accepting patients. It was initially posted on May 1st 2022 and most recently updated on May 19th 2023 to seek 78 participants from one location."
Answered by AI
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