Intervention to Change Affect Recognition & Empathy

Status Recruiting

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

Brain Concussion
Brain Injuries
Brain Injuries, Traumatic
Concussion, Intermediate
Concussion, Severe
Traumatic Brain Injury
Traumatic Brain Injury With Brief Loss of Consciousness
Traumatic Brain Injury With Loss of Consciousness
Traumatic Brain Injury With No Loss of Consciousness
Traumatic Brain Injury With Prolonged Loss of Consciousness
Unconsciousness
Wounds and Injuries

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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intervention to Change Affect Recognition and Empathy — ICARE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms