Clinical trial NCT05636020: Intervention to Change Affect Recognition and Empathy
Official title: Intervention to Change Affect Recognition and Empathy (ICARE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

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 persistent 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

Primary outcomes:
measure: Change in St. Andrew's Swansea Neurobehavioral Outcome Scale-Interpersonal Behavior (SASNOS-IB)
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Secondary outcomes:
measure: Change in The Diagnostic Assessment of Nonverbal Accuracy-2, Adult Faces (DANVA2-AF)
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in Advanced Clinical Solutions- Social Perception- Facial Affect Naming subscale (ACS-SP-FAN)
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in Brock Adaptive Functioning Questionnaire, empathy subscale (BAFQ-E)
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in Daily Empathic Behavior Survey (DEBS)
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in Participation Assessment with Combined Tools-Objective (PART-O)
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in Global Impression of Change
timeFrame: Week 14, week 26, week 38
measure: Change in Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Scale- modified
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in TBI CareQol Emotional Suppression- Short Form
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in TBI CareQol Caregiver specific Anxiety
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in Unidimensional Relationship Closeness Scale
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Change in Relationship Quality Survey
timeFrame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
measure: Treatment Satisfaction
timeFrame: Week 14
measure: Perth Empathy Scale (PES)
timeFrame: Week 7, week 14, week 26, week 38
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University
name: Flora Hammond, MD
role: PRINCIPAL_INVESTIGATOR
References: