Emotional Awareness Therapy for Traumatic Brain Injury
(TREAT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two different training programs, TREAT-A and TREAT-B, can improve emotional health in individuals who have experienced a traumatic brain injury (TBI). TREAT-A focuses on recognizing and labeling emotions, while TREAT-B teaches healthy living habits. Individuals with a moderate or severe TBI for at least six months who struggle to identify their emotions (a condition called alexithymia) may qualify to participate. Participants will attend eight one-on-one sessions over a month and complete several assessments to track progress. The study aims to enhance emotional well-being for those with TBI. As an unphased trial, it offers a unique opportunity to contribute to understanding new ways to improve emotional health after TBI.
Do I have to stop taking my current medications for the trial?
The trial requires that any medications affecting mood should be stable for at least 6 weeks before participating. If your medications have been stable for this period, you likely won't need to stop taking them.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that treatments designed to boost emotional awareness and well-being after a traumatic brain injury (TBI) are generally safe. For TREAT-A, studies found that participants often experience significant improvements in understanding their emotions, with no major safety issues. Specifically, 46% of participants noticed a positive change in their emotional awareness immediately after the treatment, and 62% reported better control over their emotions, indicating that the treatment is well-tolerated.
TREAT-B focuses on educating people about TBI and overall brain health. Similar educational programs have proven safe and are widely used without causing serious side effects. Participants in these programs usually report feeling better overall.
In summary, both training programs appear safe and may help improve emotional health for those with TBI.12345Why are researchers excited about this trial?
Unlike traditional treatments for traumatic brain injury that often focus on physical rehabilitation or medication management, Emotional Awareness Therapy (TREAT-A) targets emotional processing difficulties, specifically alexithymia. This therapy is unique because it involves psycho-educational lessons and skill-building exercises that help participants recognize and differentiate their emotions, which is a new approach for managing the emotional challenges associated with traumatic brain injury. Researchers are excited about this treatment because it aims to enhance emotional awareness, potentially leading to improved emotional health and overall well-being for individuals affected by traumatic brain injuries.
What evidence suggests that this trial's treatments could be effective for improving emotional health in people with traumatic brain injury?
Research has shown that TREAT-A, a type of Emotional Awareness Therapy, benefits people with traumatic brain injury (TBI). Studies indicate it reduces difficulties in identifying and expressing emotions and helps manage emotional challenges in those with long-term TBI. In one study, 46% of participants showed improved emotional awareness immediately after the treatment, and 62% experienced benefits later on. This therapy teaches individuals to recognize and name their emotions, enhancing emotional well-being. In this trial, participants may receive either TREAT-A or TREAT-B. TREAT-B provides education about TBI and promotes healthy living, which also supports overall well-being and emotional health.12356
Who Is on the Research Team?
Dawn Neumann, PhD, FACRM
Principal Investigator
Hackensack Meridian Health
Are You a Good Fit for This Trial?
This study is for people who have experienced a traumatic brain injury. There are no detailed inclusion or exclusion criteria listed, so anyone with a history of such an injury may be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Assessment
Participants undergo 4 assessments to gather baseline data on demographics, brain injury, and emotional health
Treatment
Participants receive 8 one-on-one training sessions over 4 weeks focusing on emotional awareness or healthy living
Follow-up
Participants complete follow-up surveys at three time points to assess emotional health and well-being
What Are the Treatments Tested in This Trial?
Interventions
- TREAT-A
- TREAT-B
Trial Overview
The trial compares two training programs: one teaches recognizing and labeling emotions (TREAT-A), the other focuses on healthy living skills (TREAT-B). Participants get assigned based on time since their injury and complete eight one-on-one sessions over about a month.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Eight lessons delivered by a trained team member (interventionist) to the participant over \~4 weeks. It involves psycho-educational lessons and skill-building exercises to achieve the following objectives based on the characteristics of alexithymia.: 1) learn benefits of emotional awareness; 2) improve threshold for earlier detection of emotional responses; 3) label and differentiate emotions; 4) experience range of emotions; and 5) distinguish emotions from thoughts, actions and sensations.
Provides education on TBI and overall brain health through instructional sessions, discussion, and structured tasks geared towards living healthy and improving general well-being.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hackensack Meridian Health
Lead Sponsor
Citations
Training to Reconnect With Emotional Awareness Therapy
Conclusions: Findings support the efficacy of TREAT for reducing alexithymia and emotion dysregulation in individuals with chronic TBI. Although outcomes were ...
Training to Reconnect With Emotional Awareness Therapy ...
Findings support the efficacy of TREAT for reducing alexithymia and emotion dysregulation in individuals with chronic TBI.
Emotional Awareness Therapy Study (TREAT)
The purpose of this study is to learn about the potential benefits of two different training programs in helping improve emotional health and ...
IU researchers develop new therapy to help brain injury ...
Forty-six percent of participants showed a clinical change in emotional awareness immediately after the treatment, and 62 percent of ...
Improving emotion regulation ability after brain injury
Fourteen of the sixteen studies reported statistically significant improvements in at least one emotional functioning variable. Ten studies reported medium- ...
6.
research-studies.allinforhealth.info
research-studies.allinforhealth.info/us/en/listing/1289/training-to-reconnect-with/Training to Reconnect With Emotional Awareness Therapy ...
The purpose of the study is to examine a new treatment designed to improve emotional awareness after TBI. After a traumatic brain injury (TBI), ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.