ICARE Treatment for Traumatic Brain Injury

(ICARE Trial)

Recruiting at 1 trial location

Overseen by Flora Hammond, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a remote rehab program called ICARE to help people with brain injuries and their caregivers improve emotional understanding and relationships. It aims to teach them how to better recognize and respond to emotions, enhancing their relationship quality and emotional well-being.

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 data supports the effectiveness of the ICARE Treatment for Traumatic Brain Injury?

Research shows that training to recognize facial emotions, which is part of the ICARE Treatment, can improve social communication skills in people with chronic traumatic brain injury. Additionally, emotion recognition training has been found effective in helping people with traumatic brain injury. ^{1 2 3 4 5}

Is the ICARE Treatment generally safe for humans?

The available research suggests that participants engaged safely with compassionate imagery exercises, which are part of the ICARE Treatment, and no safety concerns were reported in the studies reviewed. ^{2 3 4 6 7}

What makes the ICARE Treatment unique for traumatic brain injury?

The ICARE Treatment is unique because it focuses on improving emotion recognition and empathy through a tele-rehabilitation program, which is different from traditional therapies that may not specifically target these social communication skills. This approach uses technology to deliver therapy remotely, making it accessible and convenient for patients. ^{2 3 4 5 8}

Research Team

Flora Hammond, MD

Principal Investigator

Indiana University

Eligibility Criteria

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.

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• ICARE Treatment (Behavioral Intervention)

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.

Participant Groups

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+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Relationships between alexithymia, affect recognition, and empathy after traumatic brain injury. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Brief compassion focused imagery for treatment of severe head injury. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of emotion recognition training after traumatic brain injury. [2022]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A pilot feasibility study exploring the practising of compassionate imagery exercises in a nonclinical population. [2022]

8. United States 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. [2022]