TeleRehab program to improve emotion recognition and empathy in brain injury patients

Intervention to Change Affect Recognition and Empathy (ICARE)

This study is testing a TeleRehab program to see if it can help people with brain injuries and their caregivers better understand emotions and improve their relationships.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT05636020 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the feasibility and early efficacy of the ICARE TeleRehab program aimed at enhancing affect recognition and empathy in individuals with traumatic brain injury (TBI) alongside their care partners. The study employs a non-randomized, one-group pre/posttest design with assessments conducted before and after the intervention, as well as follow-ups at 3 and 6 months. The primary goals are to improve interpersonal behaviors and relationship quality for both TBI participants and their care partners, while also addressing emotional support and anxiety levels for the caregivers. A total of 40 participants will be involved in this initial phase of the study.

Who should consider this trial

Good fit: Ideal candidates include individuals with mild to severe TBI who are at least one year post-injury and have a care partner willing to participate.

Not a fit: Patients who are not experiencing difficulties with emotion recognition or empathy, or who are not at least one year post-TBI, may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly enhance emotional recognition and interpersonal relationships for patients with TBI and their caregivers.

How similar studies have performed: While similar approaches have been explored, this specific TeleRehab intervention is novel and has not been extensively tested in this context.

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

Where this trial is running

Indianapolis, Indiana

• Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: Flora Hammond, MD — Indiana University
• Study coordinator: Amanda Melton

Conditions Traumatic Brain Injury; Concussion, Intermediate; Concussion, Severe; Concussion With LOC 31 to 59 Minutes; Concussion With Brief Loss of Consciousness; Traumatic Brain Injury With Brief Loss of Consciousness; Traumatic Brain Injury With Loss of Consciousness; Traumatic Brain Injury With Prolonged Loss of Consciousness