RECRUITING

Intervention to Change Affect Recognition and Empathy

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Conditions

Traumatic Brain InjuryConcussion, IntermediateConcussion, SevereConcussion With LOC 31 to 59 MinutesConcussion With Brief Loss of ConsciousnessTraumatic Brain Injury With Brief Loss of ConsciousnessTraumatic Brain Injury With Loss of ConsciousnessTraumatic Brain Injury With Prolonged Loss of ConsciousnessTraumatic Brain Injury (TBI); Concussion, Initial EncounterTraumatic Brain Injury (TBI); Concussion, Subsequent EncounterTraumatic Brain Injury With No Loss of ConsciousnessTraumatic Brain Injury With Open Intracranial WoundTraumatic Brain Injury With Moderate Loss of Consciousnessbrain injuryaffect recognitionempathycaregiverinterpersonal behaviorsrelationship closenessmoodteletherapysocial cognitiontheory of mindperspective taking

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Intervention to Change Affect Recognition and Empathy (ICARE)

Quick Facts

Study Start:2023-03-15
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05636020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Amanda Melton
CONTACT
317-329-2380
amamelto@iu.edu
Becky Runkel, M.H.A.
CONTACT
317-329-2217
rrunkel@iu.edu

Principal Investigator

Flora Hammond, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University School of Medicine
Indianapolis, Indiana, 46254
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Flora Hammond, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15
Study Completion Date2027-08

Study Record Updates

Study Start Date2023-03-15
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • brain injury
  • affect recognition
  • empathy
  • caregiver
  • interpersonal behaviors
  • relationship closeness
  • mood
  • teletherapy
  • social cognition
  • theory of mind
  • perspective taking

Additional Relevant MeSH Terms

  • 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