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Intervention to Change Affect Recognition and Empathy — ICARE  

Traumatic Brain Injury Clinical Trial

Official title:
Intervention to Change Affect Recognition and Empathy (ICARE)

Clinical Trial Summary

Determine the feasibility, practicality, and early efficacy of a TeleRehab program (ICARE) to improve outcomes for persons with traumatic brain injury (TBI) in recognizing and responding to others' emotions alongside their care partner (CP).

Clinical Trial Description

This phase I proof of principle pilot study of ICARE will be a non-randomized, one-group pre/posttest design with a double pretest, and an immediate posttest, with 3 and 6-month follow-ups in 40 participants with TBI and their CP. The study objectives are to explore the feasibility, practicality and early efficacy of ICARE to improve affect recognition (AR), empathy, interpersonal behaviors, and participation for persons with TBI. For CPs, goals are for them to feel more emotionally supported by the person with TBI; feel more in control of their own emotions, and have less CP anxiety. An additional objective for both participants with TBI and the CP is to enhance the quality and closeness of their relationship. For both TBI and CP participants, we anticipate ICARE will have good feasibility and acceptability, and post-treatment assessments will show significant improvements in perceived relationship closeness and relationship quality. For the TBI participants, we anticipate the post-treatment assessments will show significant improvements in affect recognition, empathy, interpersonal behavior, participation, and global impression of change. For the CPs, we anticipate the post-treatment assessments will show significant improvements in perceived emotional support (received from participant with TBI); suppression of self-emotions; and self-rated anxiety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05636020
Study type Interventional
Source Indiana University
Contact Amanda Melton
Phone 317-329-2380
Email amamelto@iu.edu
Status Recruiting
Phase N/A
Start date March 15, 2023
Completion date August 2027
View Details
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