Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT05636020
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05636020
Study Brief:
Protocol Section:
NCT05636020