48 Participants NeededMy employer runs this trial

Emotional Awareness Therapy for Traumatic Brain Injury

(TREAT Trial)

GW
Overseen ByGrace Wells, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hackensack Meridian Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

DN

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

Speaks and understands English
Elevated alexithymia
I am 18 years old or older.
See 4 more

Exclusion Criteria

Active or uncontrolled major psychiatric disorder
Conditions posing safety concern to self or others, such as suicide risk
I have a neurological disorder that is not caused by a traumatic brain injury.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo 4 assessments to gather baseline data on demographics, brain injury, and emotional health

1-2 weeks
4 assessments (virtual)

Treatment

Participants receive 8 one-on-one training sessions over 4 weeks focusing on emotional awareness or healthy living

4 weeks
8 sessions (virtual)

Follow-up

Participants complete follow-up surveys at three time points to assess emotional health and well-being

6 months
3 follow-up assessments (virtual)

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

Group I: TREAT-AExperimental Treatment1 Intervention
Group II: TREAT-BActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials
141
Recruited
42,900+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39154927/

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