Intervention to Change Affect Recognition and Empathy

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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).

Study Overview

Start Date
March 15, 2023
Completion Date
August 1, 2027
Enrollment
80
Date Posted
December 5, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Raven Hill
Indianapolis, Indiana 46254, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria for TBI participant:

Mild, moderate, or severe TBI determined by The Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) during Time 1; if mild, must have been at least dazed and confused. Must be ≥ 1-year post-TBI (unlikely spontaneous recovery). Must have a care-partner (CP) willing to participate. Must either have a ≤ 45 T score on any one of the SASNOS Interpersonal Behavior subscales or Total Interpersonal behavior score, OR select never, rarely, or occasionally to #2, #6, #7, and/ or #12 (obtained during screening process). Also, either: A) Must be believed by person with TBI OR B) Person with TBI has been told by others OR CP, that their problems with recognizing and/ or empathizing with others' emotions (self or CP rated) are believed to be new or worse since TBI and impacting their interpersonal behaviors or relationships.

Inclusion Criteria for CP:

Must be a relative, spouse, or friend who believes the have sufficient interactions (~3 times/ week) with the participant with TBI to judge their empathic, interpersonal, and other behaviors. Must be willing to participate in assessments and empathy sessions.

Inclusion Criteria for both TBI and CP:

Must be ≥18 years old. Must be a U.S. resident (exclusion for California residents). Must be proficient in English; have basic comprehension & ability to follow directions (determined via interaction at screening); have access to a computer or tablet with reliable internet (capacity for video conferencing) with video-conferencing capability.

Exclusion Criteria for TBI participant:

Any other formal neurological disorder or condition that impacts emotional functioning other than TBI (e.g., stroke); suicide risk determined to be >low risk based on PI discretion and/or results of suicide protocol (if triggered); unstable or anticipated medication changes that will influence mood/ affect during study participation; and individuals who recently started psychotherapy (e.g., < 3 months ago) and/or active treatment in family or couples therapy.

Exclusion Criteria for CP:

Moderate to severe TBI determined by the "OSU TBI-ID + ABI" (i.e., scoring a 4 or 5 on Worst Injury Scale); If the person indicates a mild TBI (OSU score of 2 or 3) or any other neurological impairment on the OSU (e.g. a stroke), then the person will be asked follow-up questions to determine if there were any persis-tent changes in thinking, memory, mood, social functioning that they believe was a result of the injury. PI and/ or Co-PI discretion will be used to evaluate the answer and determine inclusion or exclusion.

Exclusion Criteria for both TBI and CP:

Developmental; neurodegenerative; major psychiatric disorder (e.g., schizophrenia, personality disorder); visual, hearing, or communication deficits that would impede participation; participation in IRB#12561; contemplating separation or divorce with the dyad partner

Study Contact Info

Study Contact Name
Raven Hill, M.A.; Becky Runkel, M.H.A.
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT05636020