Volunteers and Their Care Partners Needed for Traumatic Brain Injury (TBI) Study (ICARE)
Flora Hammond, MD
Primary Investigator
Brief description of study
Have you or someone you know experienced a traumatic brain injury and are struggling to recognize and respond to how others feel?
Join our ICARE study!
Indiana University School of Medicine is conducting a study to find out if a new teletherapy program can help individuals with traumatic brain injury (TBI) better recognize and respond to others' feelings, and improve their relationships.
We are inviting volunteers who are ages 18 and older, who have experienced a traumatic brain injury (TBI) at least 12 months ago, and who also have a friend or family member who can participate in the study along with them.
All study activities can be completed online/virtually - NO IN-PERSON VISITS ARE REQUIRED.
Why Participate in ICARE?
- Better recognize and respond to others’ emotions
- May help you to be more emotionally connected with others and supportive of loved ones
- Potential to improve relationships with others
- You will help contribute to knowledge needed to achieve better social outcomes and relationship quality for people with a brain injury
- You will be compensated for your time
Detailed description of study
What the study involves:
Phone screening: We will collect demographic data, information about your brain injury, relevant medical history, and social behaviors to help us determine if you meet the criteria to participate in the study. Your ICARE partner (i.e., a family member, friend, or partner you identify to participate) will do a separate but similar screening to this.
Assessment Visits 1 and 2: You will be interviewed via secure videoconference about demographics and injury-related information. We will complete assessments and questionnaires about your emotion recognition, empathy, social behaviors, and relationships. Your ICARE partner will not be present with you during these sessions.
Intervention: You will undergo virtual treatment via secure videoconference with a trained clinician. This will include twelve treatment sessions lasting approximately 60-90 minutes. Sessions include lessons and exercises that focus on recognizing facial expressions, imitating emotions, processing emotional responses to events in your life, and empathy. During the sessions, you will be expected to discuss your own personal emotional experiences and those of your ICARE partner. Your ICARE partner will be asked to join some of the sessions.
Assessment Visits 3, 4, and 5: You will complete three, virtual one-hour visits that involve the same type of assessments as Assessment 2. Also, questions will be asked about changes you have experienced in your emotional functioning and relationship quality while participating in the study. At Assessment 3 only, you will also be asked questions about your satisfaction with the treatment.
The duration of your participation in the study will last approximately 9 months.
Additional Information
Study title: Intervention To Change Affect Recognition and Empathy (ICARE)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Traumatic Brain Injury, TBI
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria:
- Had a traumatic brain injury (TBI) at least 12 months ago
- Are 18 years of age or older
- Have access to a computer or tablet capable of video conference
- Have a relative, partner, or close friend with whom you interact with often who is willing to participate in the study
Find a site
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What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
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