NCT05636020

Intervention to Change Affect Recognition and Empathy

Intervention to Change Affect Recognition and Empathy (ICARE)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

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
• Traumatic Brain Injury (TBI); Concussion, Initial Encounter
• Traumatic Brain Injury (TBI); Concussion, Subsequent Encounter
• Traumatic Brain Injury With No Loss of Consciousness
• Traumatic Brain Injury With Open Intracranial Wound
• Traumatic Brain Injury With Moderate Loss of Consciousness

Interventions

Type	Name	Description
BEHAVIORAL	ICARE Treatment	The treatment is 12 teletherapy sessions lasting approximately 60-90 minutes. Of the 12 treatment sessions, 7 of them will focus on training skills to help the participant with TBI better recognize emotions from facial expressions. The remaining 5 sessions will teach skills important for empathizing with others' thoughts and feelings, and how to be emotionally supportive. Role-playing will be a big part of these last 5 sessions. The care-partner will be expected to attend as many of these 5 empathy sessions with the participant with TBI as possible.

Timeline

• Start date: 2023-03-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-12-05
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States