ICARE Treatment for Traumatic Brain Injury (ICARE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByFlora Hammond, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
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.
12345Is 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.
23467What 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.
23458Eligibility 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.Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Treatment (ICARE)Experimental Treatment1 Intervention
ICARE treatment consisting of 12 sessions that train affect recognition and empathic behaviors.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Indiana University School of MedicineIndianapolis, IN
Raven HillIndianapolis, IN
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
References
Relationships between alexithymia, affect recognition, and empathy after traumatic brain injury. [2022]To determine (1) alexithymia, affect recognition, and empathy differences in participants with and without traumatic brain injury (TBI); (2) the amount of affect recognition variance explained by alexithymia; and (3) the amount of empathy variance explained by alexithymia and affect recognition.
Empathic Responses to Affective Film Clips Following Brain Injury and the Association With Emotion Recognition Accuracy. [2019]To compare empathic responses to affective film clips in participants with traumatic brain injury (TBI) and controls, and examine associations with affect recognition.
Brief compassion focused imagery for treatment of severe head injury. [2019]To determine whether participants with severe head injury (SHI) allocated to a brief compassion focused imagery (CFI) intervention show greater change in compassion than those exposed to relaxation imagery (RI).
Facial Affect Recognition Training Through Telepractice: Two Case Studies of Individuals with Chronic Traumatic Brain Injury. [2020]The use of a modified Facial Affect Recognition (FAR) training to identify emotions was investigated with two case studies of adults with moderate to severe chronic (> five years) traumatic brain injury (TBI). The modified FAR training was administered via telepractice to target social communication skills. Therapy consisted of identifying emotions through static facial expressions, personally reflecting on those emotions, and identifying sarcasm and emotions within social stories and role-play. Pre- and post-therapy measures included static facial photos to identify emotion and the Prutting and Kirchner Pragmatic Protocol for social communication. Both participants with chronic TBI showed gains on identifying facial emotions on the static photos.
A randomized controlled trial of emotion recognition training after traumatic brain injury. [2022]To examine the effectiveness of 2 affect recognition interventions (Faces and Stories) in people with a traumatic brain injury.
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]New technologies such as multitouch-multiuser tabletops (MMT) and virtual reality (VR) provide modern neurorehabilitation options. The aim was to describe the structure of acquired social communication deficits in children with neurological disorders (ND) and implement a new PowerVR method- combined MMT/VR interfaces, into social neurorehabilitation. The study was designed based on the Structured Social Rehabilitation Model. Sixty children with ND aged 8-13 years participated: 28 with epilepsy, 10 with traumatic brain injury (TBI), 3 with tic disorders, 3 with stroke, 16 with other ND. A total of 16 patients (M = 10.5 years, SD = 1.8) completed trainings with pre- and post-intervention assessments. Forty-four patients participated in base-level assessment (M = 10.2 years, SD = 1.6). Two age-matched patients practiced in pairs on MMT and individually in VR. The most impaired components in patients were theory of mind (ToM) skills. A total of 64% of children presented behavioral problems related to executive dysfunctions. Patients lacked conflict resolution (median 38% out of 100%) and empathy skills (25%). After trainings, communication and cooperation, pragmatics, social attention, conflict resolution, and empathy skills improved. Patients' general verbal ToM and understanding false beliefs (p < .005) increased. Children's ability to start conversations improved; they experienced less bullying. Findings suggest that the combined technology-based intervention PowerVR offers increased power for multicomponent training of socio-emotional skills.
A pilot feasibility study exploring the practising of compassionate imagery exercises in a nonclinical population. [2022]This study assessed the acceptability of practising compassionate imagery as an online task without clinician support. Participants completed questionnaires at baseline, after, and 6 months of follow-up. Participants engaged safely and successfully with the tasks. There were significant improvements in questionnaire scores which were largely maintained over 6 months.
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]We discuss the rationale and description of the Internet-Based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT), a telehealth intervention designed to promote positive parenting skills through live in-session skills practice and coaching. A second objective is to describe the protocol of a three-armed (Internet Resource Comparison, I-InTERACT, and I-InTERACT Express) multi-site randomized controlled trial (RCT) designed to examine intervention effectiveness.