ICARE Treatment for Traumatic Brain Injury

(ICARE Trial)

Recruiting at 1 trial location

Overseen By Amanda Melton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Neurological disorder, Suicide risk, Major psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 14 weeks

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a TeleRehab program called ICARE, designed to help people with traumatic brain injury (TBI) and their care partners improve their ability to recognize and respond to emotions. The program includes 12 sessions focused on developing affect recognition and empathic behaviors. It suits individuals who experienced a TBI at least a year ago and have noticed new or worsening issues with understanding or empathizing with others' emotions. Participants should also have a care partner willing to join the sessions and meet specific criteria regarding interpersonal interactions. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods for enhancing emotional understanding and empathy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes participants with unstable or anticipated medication changes that could affect mood during the study.

What prior data suggests that the ICARE Treatment is safe for individuals with traumatic brain injury?

Research has shown that the ICARE treatment helps people with traumatic brain injury (TBI) and their caregivers better understand emotions. Studies have not reported any negative side effects from the ICARE treatment, suggesting it is likely well-tolerated.

The trial is marked as "Not Applicable" in terms of phase, indicating it is probably in the early stages. Early trials usually focus on safety, so any major safety issues would likely have been identified by now. Additionally, the treatment is a TeleRehab program, which is generally low-risk because it is conducted remotely and is non-invasive.

Overall, no specific evidence of safety problems with the ICARE treatment has been found, indicating it is generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for traumatic brain injury, which often focus on physical rehabilitation or medication to manage symptoms, the ICARE treatment is unique because it specifically targets affect recognition and empathic behaviors. This approach is innovative because it addresses the social and emotional challenges faced by patients, which are often overlooked by traditional therapies. Researchers are excited because ICARE has the potential to improve interpersonal skills and emotional well-being through a structured program of 12 sessions, offering a new dimension of recovery for those with traumatic brain injury.

What evidence suggests that the ICARE Treatment is effective for traumatic brain injury?

Research has shown that the ICARE treatment, which participants in this trial will receive, helps people with traumatic brain injury (TBI) and their caregivers better understand and empathize with emotions. Early results suggest it improves the ability to recognize others' feelings. The program includes 12 online sessions focused on developing these skills. While initial evidence is promising, further studies are underway to confirm its effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Flora Hammond, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for U.S. residents over 18 years old who are at least one year post-traumatic brain injury (TBI) and have difficulties with emotion recognition or empathy that they believe started after TBI. Participants must speak English, be able to follow directions, and have a care partner willing to join the study. They need internet access for video calls but can't be from California or have other neurological conditions affecting emotions.

Inclusion Criteria

TBI participant must have a care-partner (CP) willing to participate

My caregiver is someone close who sees me about 3 times a week and can judge my social behaviors.

It has been over a year since my traumatic brain injury.

Exclusion Criteria

TBI participant must not have a suicide risk determined to be >low risk based on PI discretion and/or results of suicide protocol (if triggered)

My medications affecting mood will remain stable during the study.

I haven't started any new psychotherapy or family/couples therapy in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

14 weeks

12 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Assessments at week 14, week 26, and week 38

What Are the Treatments Tested in This Trial?

Interventions

• ICARE Treatment

Trial Overview The ICARE Treatment program is being tested in this trial. It's a TeleRehab intervention designed to help people with TBI improve their ability to recognize and respond to others' emotions using video conferencing technology alongside their care partners.

How Is the Trial Designed?

Group I: Treatment (ICARE) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

The modified Facial Affect Recognition (FAR) training delivered via telepractice effectively improved the ability of two adults with chronic traumatic brain injury (TBI) to identify emotions from static facial expressions.

Both participants demonstrated measurable gains in recognizing facial emotions after therapy, indicating that targeted social communication skills training can be beneficial for individuals with moderate to severe TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial Affect Recognition Training Through Telepractice: Two Case Studies of Individuals with Chronic Traumatic Brain Injury. Williamson, J., Isaki, E.[2020]

The I-InTERACT telehealth intervention aims to enhance positive parenting skills for parents of children aged 3-9 who have experienced a traumatic brain injury, with a focus on live skills practice and coaching.

This study represents a significant effort as one of the first large multi-site randomized controlled trials to evaluate the effectiveness of a parenting intervention in this context, with expectations of improved parenting behaviors and reduced child behavior problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT): Protocol for a multi-site randomized controlled trial of an internet-based parenting intervention. Narad, ME., Taylor, HG., Yeates, KO., et al.[2022]

The study found that a brief compassion focused imagery (CFI) intervention did not lead to significant changes in self-reported compassion or heart rate variability in participants with severe head injury, compared to a relaxation imagery (RI) intervention.

However, both groups showed improvements in relaxation and reduced state anxiety, suggesting that while CFI may not be effective in this context, the preparatory video increased motivation for therapy, highlighting the importance of understanding therapeutic mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief compassion focused imagery for treatment of severe head injury. Campbell, IN., Gallagher, M., McLeod, HJ., et al.[2019]

The Faces Intervention significantly improved facial affect recognition in individuals with moderate to severe traumatic brain injury, with effects lasting for 6 months after treatment.

No significant improvements were found with the Stories Intervention compared to the Control, indicating that the Faces Intervention may be more effective for enhancing specific emotional recognition skills in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of emotion recognition training after traumatic brain injury. Neumann, D., Babbage, DR., Zupan, B., et al.[2022]

Participants were able to safely and effectively engage in compassionate imagery tasks online without clinician support, showing significant improvements in their self-reported questionnaire scores.

These improvements were largely maintained over a 6-month follow-up period, suggesting that compassionate imagery can be a beneficial adjunct to traditional psychotherapy, even for those with higher levels of self-criticism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot feasibility study exploring the practising of compassionate imagery exercises in a nonclinical population. McEwan, K., Gilbert, P.[2022]

Adults with moderate-to-severe traumatic brain injury (TBI) showed significantly higher levels of alexithymia, which is the difficulty in identifying and describing feelings, along with poorer abilities in recognizing facial and vocal emotions and lower empathy scores compared to controls.

Alexithymia, particularly the aspect of externally-oriented thinking, explained a notable portion of the difficulties in affect recognition and cognitive empathy in TBI participants, indicating that addressing these emotional processing issues could be important in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between alexithymia, affect recognition, and empathy after traumatic brain injury. Neumann, D., Zupan, B., Malec, JF., et al.[2022]

A study involving 60 children with neurological disorders showed that a combined multitouch-multiuser tabletop and virtual reality (PowerVR) intervention significantly improved social communication skills, particularly in areas like conflict resolution and empathy.

After the intervention, children demonstrated enhanced theory of mind abilities and better verbal communication, leading to reduced bullying experiences, indicating the efficacy of technology-based neurorehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Power of combined modern technology: Multitouch-multiuser tabletops and virtual reality platforms (PowerVR) in social communication skills training for children with neurological disorders: A pilot study. Kolk, A., Saard, M., Roštšinskaja, A., et al.[2023]

Adults with moderate to severe traumatic brain injury (TBI) showed significantly lower emotion recognition and empathic responses compared to controls, with only 65% of TBI participants accurately identifying emotions and responding empathically, compared to 78% in controls.

The study found that when TBI participants correctly recognized emotions, they had a 71% chance of responding empathically, highlighting the importance of affect recognition in fostering empathy, which can impact their interpersonal relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empathic Responses to Affective Film Clips Following Brain Injury and the Association With Emotion Recognition Accuracy. Neumann, D., Zupan, B.[2019]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05636020/intervention-to-change-affect-recognition-and-empathy

Intervention to Change Affect Recognition and Empathy The study objectives are to explore the feasibility, practicality and early efficacy of ICARE to improve affect recognition (AR), empathy, ...

2. peearz.com peearz.com/trialsindex?nctid=NCT05636020

Intervention to Change Affect Recognition and Empathy Determine the feasibility, practicality, and early efficacy of a TeleRehab program (ICARE) to improve outcomes for persons with traumatic brain injury (TBI) ...

3. withpower.com withpower.com/trial/phase-concussion-with-brief-loss-of-consciousness-2023-bcf43

ICARE Treatment for Traumatic Brain Injury (ICARE Trial) This trial tests a remote rehab program called ICARE to help people with brain injuries and their caregivers improve emotional understanding and ...

4. msktc.org msktc.org/tbi/projects/intervention-change-affect-recognition-and-empathy-icare

Intervention To Change Affect Recognition and Empathy ... The aim of the ICARE study is to evaluate feasibility and early efficacy of a remotely-delivered intervention for affect recognition (AR) and empathy for ...

5. tbindsc.org tbindsc.org/StaticFiles/Documents/2023%20TBIMS%20Slide%20Presentation.pdf

The Traumatic Brain Injury Model Systems • Intervention to Change Affect Recognition and Empathy (ICARE). • Improving ... Traumatic Brain Injury: Incidence and. Impact on Outcome. • Moderate to ...