Intervention to Change Affect Recognition and Empathy

NCT05636020 | Active Not Recruiting DMC

• 1 other identifier: 16937
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in St. Andrew's Swansea Neurobehavioral Outcome Scale-Interpersonal Behavior (SASNOS-IB)

  Behaviors and symptoms of neurobehavioral dysfunction are rated on items covering 5 major domains, one of which is interpersonal behavior, which has 3 subdomains (social interactions, relationships, engagement). Prevalence of behaviors are rated using a 7-point scale ('never' to 'always'). Participants with TBI and CP will only complete the Interpersonal Behavior (IB) domain about the person with TBI. Psychometric property testing indicated excellent discriminant validity and good test-retest reliability.

  Baseline (pre-test 1), week 7, week 14, week 26, week 38

Secondary Outcomes (13)

• Change in The Diagnostic Assessment of Nonverbal Accuracy-2, Adult Faces (DANVA2-AF)

  Baseline (pre-test 1), week 7, week 14, week 26, week 38

• Change in Advanced Clinical Solutions- Social Perception- Facial Affect Naming subscale (ACS-SP-FAN)

  Baseline (pre-test 1), week 7, week 14, week 26, week 38

• Change in Brock Adaptive Functioning Questionnaire, empathy subscale (BAFQ-E)

  Baseline (pre-test 1), week 7, week 14, week 26, week 38

• Change in Daily Empathic Behavior Survey (DEBS)

  Baseline (pre-test 1), week 7, week 14, week 26, week 38

• Change in Participation Assessment with Combined Tools-Objective (PART-O)

  Baseline (pre-test 1), week 7, week 14, week 26, week 38

Study Arms (1)

Treatment (ICARE)

EXPERIMENTAL

ICARE treatment consisting of 12 sessions that train affect recognition and empathic behaviors.

Behavioral: ICARE Treatment

Interventions

ICARE Treatment BEHAVIORAL

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.

Treatment (ICARE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46254, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Flora Hammond, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 5, 2022
• Study Start: March 15, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (1)