Intervention to Change Affect Recognition and Empathy

Launched by INDIANA UNIVERSITY · Dec 1, 2022

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