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Intervention to Change Affect Recognition and Empathy

NCT05636020 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-11-03

No results posted yet for this study

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).

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

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.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Flora Hammond, MD · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636020 on ClinicalTrials.gov