Intervention to Change Affect Recognition and Empathy (ICARE)

August 4, 2026 updated by: Flora Hammond, Indiana University

Intervention to Change Affect Recognition and Empathy (ICARE)

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Becky Runkel, M.H.A.
  • Phone Number: 317-329-2217
  • Email: rrunkel@iu.edu

Study Contact Backup

Study Locations

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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment (ICARE)
ICARE treatment consisting of 12 sessions that train affect recognition and empathic behaviors.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in St. Andrew's Swansea Neurobehavioral Outcome Scale-Interpersonal Behavior (SASNOS-IB)
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in The Diagnostic Assessment of Nonverbal Accuracy-2, Adult Faces (DANVA2-AF)
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
(TBI participant only) The DANVA2-AF is a standardized performance-based measure of facial affect recognition. Participants will be shown 24 photographs of 4 facial expressions (different faces from ICARE training) and required to select a response option from a list of choices. Scores range from 0-24. The DANVA2-AF has high internal consistency, test-retest reliability, and good convergent validity.
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)
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
(TBI participant only) In this affect recognition test, participants are shown 24 faces (different from ICARE training) that express happy, sad, angry, fearful, disgust, surprise or neutral emotions and must choose from a list of response options. The ACS-SP-FAN has good discriminant validity, high internal consistency, and high test-retest reliability.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Brock Adaptive Functioning Questionnaire, empathy subscale (BAFQ-E)
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
This subjective measure, which has been designed for self and proxy ratings, includes several subscales (including empathy) to evaluate neurobehavioral functioning. Only the empathy subscale will be completed. Both the participant with TBI (self-rated) and their CP (about person with TBI). They will rate the frequency of occurrence of empathic behaviors on a 5-point scale. The BAFQ has high internal consistency, good concurrent validity with executive functioning measures, and correlates highly with caregiver stress and satisfaction, and return to work.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Daily Empathic Behavior Survey (DEBS)
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
(CP participant only) The DEBS was created for this study. For 1-week (7 days) intervals following each time frame point, CPs will be sent an electronic prompt to their cell phones at the end of the day and asked to rate the following statements on a scale from 1 (not at all) to 5 (extremely): Today, he/she 1) tried to understand others' thoughts, feelings, or problems; 2) considered others' perspectives and situations; 3) shared in others' feelings (e.g., felt sad with someone sad; felt happy with someone happy); 4) showed care and concern for others (e.g., asked, listened, comforted, consoled); 5) listened when others needed to talk; and 6) showed appreciation to others. If the CP did not interact with the participant that day, they will reply "no interaction" to that daily survey. While administered 7 times per time frame point/assessment period, the goal is a minimum of 3 completed surveys that period.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Participation Assessment with Combined Tools-Objective (PART-O)
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
(TBI participant only) PART-O is a standardized 17-item measure developed by the TBIMS to evaluate participation in the community with respect to three domains: Productivity, Social Relations, and Out and About. Items are scored on a 0 to 5 scale. Total PART-O scores will be used for our analyses.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Global Impression of Change
Time Frame: Week 14, week 26, week 38
Using a 7-point Likert scale, participants with TBI and CP will be asked to rate the degree of change (1=no change; 7=a great deal better) in a) overall functioning, b) empathy, and c) social behaviors of the person with TBI, as believed to be related to ICARE.
Week 14, week 26, week 38
Change in Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Scale- modified
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
(CP participant only) This 8-item subjective measure requires participants to rate the degree of emotional support they receive using a 5-point Likert scale. It will be completed by CP and modified to specifically inquire about the emotional support they receive from the participant with TBI (as opposed to support from anyone). PROMIS item banks and their short forms have been found to be reliable and precise measures that are comparable to legacy instruments.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in TBI CareQol Emotional Suppression- Short Form
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
(CP participant only) Six items assess CP attempts to hide or suppress negative feelings in their caregiver role. Psychometric properties are strong.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in TBI CareQol Caregiver specific Anxiety
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
(CP participant only) This scale examines caregiver concerns about the person they care for with regard to behavior in public, mental health, mood, and fear for the future on a 5-point Likert-type scale ranging from 1 (Never) to 5 (Always). Scores are converted to a T-scale with a mean of 50 (SD=10). Higher scores indicate more anxiety. With rigorous development standards, it has been found to have strong psychometric properties.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Unidimensional Relationship Closeness Scale
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
To be completed by participants with TBI and their CP, this 12-item self-report scale measures the closeness of social and personal relationships using a 7-point Likert scale from Strongly Disagree to Strongly Agree. Has good psychometric qualities.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Relationship Quality Survey
Time Frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
This brief survey uses a 10-point scale to rate the quality of their relationship (from very poor to outstanding). It will be completed both by the participant with the TBI and their CP.
Baseline (pre-test 1), week 7, week 14, week 26, week 38
Treatment Satisfaction
Time Frame: Week 14
Participants with TBI and CP will complete a post-treatment survey regarding their satisfaction with content and with remote delivery of the therapy program, using a 9-point scale. For example, participants will be asked questions, such as: "Overall, how satisfied were you with ICARE therapy?" (Content satisfaction); and "How satisfied were you with receiving this type of treatment remotely/ via teletherapy?" (Teletherapy satisfaction). To guide future iterations, participants will be asked to describe 2-3 three things they liked, disliked and would change; and seek feedback on how the program could be improved.
Week 14
Perth Empathy Scale (PES)
Time Frame: Week 7, week 14, week 26, week 38
The Perth Empathy Scale (PES) is a subjective measure that evaluates general empathy ability that can be separated into cognitive and affective (negative and positive) empathy domains on a 5-point scale (1=Almost never; 5=Almost always). This subjective measure has also been designed to capture informant ratings, thus, both the participant with TBI (self-rated) and their CP (about person with TBI) will be assessed. Higher scores represent better empathic ability. Total scores range from 20-100; subscale scores range from 10-50 each. Participants will rate the frequency of occurrence in each behavior or experience. The PES has high convergent validity, discriminant validity in comparison to constructs like alexithymia, and criterion validity in assessing empathy in both positive and negative emotions.
Week 7, week 14, week 26, week 38

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Flora Hammond, MD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16937

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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