Intervention to Change Affect Recognition and Empathy
Launched by INDIANA UNIVERSITY · Dec 1, 2022
Trial Information
Current as of February 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called "Intervention to Change Affect Recognition and Empathy," aims to explore a new online rehabilitation program (called ICARE) designed to help individuals with traumatic brain injury (TBI) improve their ability to recognize and respond to other people's emotions. The trial is looking for participants who are at least one year post-injury and have a care partner, such as a family member or friend, who can join them in the study. Eligible participants must have mild to severe TBI and experience difficulties in understanding emotions, which have worsened since their injury.
Participants in the trial can expect to take part in assessments and empathy sessions conducted online. Both the individual with TBI and their care partner must be at least 18 years old, fluent in English, and have access to a computer or tablet with a reliable internet connection for video meetings. It's important to note that individuals with certain other neurological conditions or psychiatric disorders, as well as those who are at risk for suicide, cannot participate. This study is currently recruiting participants, and it aims to find out if this program can effectively help improve emotional understanding and interpersonal relationships for those affected by TBI.
Gender
ALL
Eligibility criteria
- Inclusion Criteria for TBI participant:
- • Mild, moderate, or severe TBI determined by The Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) during Time 1; if mild, must have been at least dazed and confused. Must be ≥ 1-year post-TBI (unlikely spontaneous recovery). Must have a care-partner (CP) willing to participate. Must either have a ≤ 45 T score on any one of the SASNOS Interpersonal Behavior subscales or Total Interpersonal behavior score, OR select never, rarely, or occasionally to #2, #6, #7, and/ or #12 (obtained during screening process). Also, either: A) Must be believed by person with TBI OR B) Person with TBI has been told by others OR CP, that their problems with recognizing and/ or empathizing with others' emotions (self or CP rated) are believed to be new or worse since TBI and impacting their interpersonal behaviors or relationships.
- Inclusion Criteria for CP:
- • Must be a relative, spouse, or friend who believes the have sufficient interactions (\~3 times/ week) with the participant with TBI to judge their empathic, interpersonal, and other behaviors. Must be willing to participate in assessments and empathy sessions.
- Inclusion Criteria for both TBI and CP:
- • Must be ≥18 years old. Must be a U.S. resident (exclusion for California residents). Must be proficient in English; have basic comprehension \& ability to follow directions (determined via interaction at screening); have access to a computer or tablet with reliable internet (capacity for video conferencing) with video-conferencing capability.
- Exclusion Criteria for TBI participant:
- • Any other formal neurological disorder or condition that impacts emotional functioning other than TBI (e.g., stroke); suicide risk determined to be \>low risk based on PI discretion and/or results of suicide protocol (if triggered); unstable or anticipated medication changes that will influence mood/ affect during study participation; and individuals who recently started psychotherapy (e.g., \< 3 months ago) and/or active treatment in family or couples therapy.
- Exclusion Criteria for CP:
- • Moderate to severe TBI determined by the "OSU TBI-ID + ABI" (i.e., scoring a 4 or 5 on Worst Injury Scale); If the person indicates a mild TBI (OSU score of 2 or 3) or any other neurological impairment on the OSU (e.g. a stroke), then the person will be asked follow-up questions to determine if there were any persistent changes in thinking, memory, mood, social functioning that they believe was a result of the injury. PI and/ or Co-PI discretion will be used to evaluate the answer and determine inclusion or exclusion.
- Exclusion Criteria for both TBI and CP:
- • Developmental; neurodegenerative; major psychiatric disorder (e.g., schizophrenia, personality disorder); visual, hearing, or communication deficits that would impede participation; participation in IRB#12561; contemplating separation or divorce with the dyad partner
Trial Officials
Flora Hammond, MD
Principal Investigator
Indiana University
About Indiana University
Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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