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ICARE Treatment for Traumatic Brain Injury (ICARE Trial)
N/A
Recruiting
Led By Dawn Neumann, Ph.D.
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-test 1), week 7, week 14, week 26, week 38
Awards & highlights
ICARE Trial Summary
This trial tests an online program to help people with TBI recognize & respond to emotions with their care partner for improved outcomes.
Who is the study for?
This trial is for U.S. residents over 18 years old who are at least one year post-traumatic brain injury (TBI) and have difficulties with emotion recognition or empathy that they believe started after TBI. Participants must speak English, be able to follow directions, and have a care partner willing to join the study. They need internet access for video calls but can't be from California or have other neurological conditions affecting emotions.Check my eligibility
What is being tested?
The ICARE Treatment program is being tested in this trial. It's a TeleRehab intervention designed to help people with TBI improve their ability to recognize and respond to others' emotions using video conferencing technology alongside their care partners.See study design
What are the potential side effects?
Since ICARE Treatment involves therapy sessions rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort or fatigue during the exercises aimed at improving affect recognition and empathy.
ICARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-test 1), week 7, week 14, week 26, week 38
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-test 1), week 7, week 14, week 26, week 38
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in St. Andrew's Swansea Neurobehavioral Outcome Scale-Interpersonal Behavior (SASNOS-IB)
Secondary outcome measures
Change in Advanced Clinical Solutions- Social Perception- Facial Affect Naming subscale (ACS-SP-FAN)
Change in Brock Adaptive Functioning Questionnaire, empathy subscale (BAFQ-E)
Change in Daily Empathic Behavior Survey (DEBS)
+10 moreICARE Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ICARE)Experimental Treatment1 Intervention
ICARE treatment consisting of 12 sessions that train affect recognition and empathic behaviors.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,196 Total Patients Enrolled
Dawn Neumann, Ph.D.Principal InvestigatorIndiana University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medications affecting mood will remain stable during the study.I haven't started any new psychotherapy or family/couples therapy in the last 3 months.I have TBI and no other neurological conditions affecting my emotions.My caregiver is someone close who sees me about 3 times a week and can judge my social behaviors.Neither I nor my care partner have issues with sight, hearing, or speaking that would stop us from participating.Neither I nor my care partner have developmental, neurodegenerative, or major psychiatric disorders.I am 18 years old or older.It has been over a year since my traumatic brain injury.My partner and I are not considering separation or divorce.I have had a traumatic brain injury, ranging from mild to severe.I had a TBI at least a year ago, have issues recognizing emotions, and have a care-partner.I and my care partner speak English, can follow directions, and have a computer or tablet with internet for video calls.I am over 18, live in the U.S. but not in California, speak English well, and have a computer or tablet with internet for video calls.I am close to someone with TBI and interact with them often enough to notice changes in their behavior.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ICARE)
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.
Are there still opportunities to become involved in this research?
"This clinical trial is presently searching for suitable participants, as indicated on the directory hosted by clinicaltrials.gov. The medical study was initially posted on March 15th 2023 with a most recent update taking place April 25th of the same year."
Answered by AI
What is the target enrollment of participants for this research?
"Indeed, the details found on clinicaltrials.gov demonstrate that this research project is presently in a state of recruitment. It was initially posted on March 15th 2023 and subsequently updated to its current version April 25th 2023. 80 volunteers are needed from 1 medical facility for completion of the trial."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
Raven Hill
What portion of applicants met pre-screening criteria?
Did not meet criteria
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