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Emotional Awareness Therapy for Traumatic Brain Injury

This study is exploring two different training programs, TREAT-A and TREAT-B, to help people who have experienced a traumatic brain injury (TBI) improve their emotional health. TREAT-A focuses on recognizing and understanding emotions, aiming to reduce feelings of confusion, numbness, anger, stress, and being overwhelmed. TREAT-B teaches strategies for overall brain health and setting personal goals to improve quality of life. You may be able to join if you are 18 or older, had a moderate or severe TBI at least six months ago, speak English, and have stable mood medications. The study aims to see if these programs can improve emotional well-being and help us learn more about better emotional health outcomes for people with TBI. The study plans to enroll 48 participants, but its current status is unclear.

Study design
This interventional study is testing two behavioral programs, TREAT-A and TREAT-B, with a planned enrollment of 48 participants.
What's involved
You would participate in one of two programs and complete four assessments, each lasting 30-60 minutes, using video calls, phone calls, or online surveys.
Compensation
Not stated in the trial record.
Follow-up
Your satisfaction will be measured immediately after treatment, and interventionist evaluations will occur during training sessions over approximately 8 months.

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NCT07624825

Emotional Awareness Therapy Study

Recruiting
NAAges 18+InterventionalTreatment
Hackensack Meridian Health
~48 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:TREAT-ATREAT-B

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ineligibility and Attrition Rates
Measured over Through study completion, an average of 8 months
+4 more outcomes measured

Conditions

Traumatic Brain Injury

Explore related trials

ConcussionTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Dawn Neumann, PhD, FACRM · PRINCIPAL_INVESTIGATOR · Hackensack Meridian Health

Who to contact

Grace Wells, BS
[email protected]
732-321-7000 · ext. 68682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Moderate or Severe TBI
≥18 years old
≥6 months post-TBI
Speaks and understands English
Medications that can influence mood should be stable (6+ weeks)
Elevated alexithymia
Demonstrate an understanding of the study and their rights (e.g. ability to answer the following questions correctly after a review of the study details during pre-screening process)

Exclusion

Premorbid neurological disorder other than TBI
Degenerative neurologic condition
Active or uncontrolled major psychiatric disorder
Conditions that pose safety concern to self or others, such as suicide risk
Visual, hearing, communication, or cognitive impairments that would impede participation
Active involvement in an intensive rehabilitation program
Individuals who recently started psychotherapy and/or mental health counseling

What this trial measures

  • Ineligibility and Attrition RatesThrough study completion, an average of 8 months

    Data will be tracked on the number of individuals who were ineligible (and reasons for ineligibility) as well as withdrawals (reasons for withdrawal) and /or number of participants who become "lost" (no longer able to contact).

  • Satisfaction Survey and Interviewimmediate post-treatment

    Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied

  • Interventionist Evaluation of Session Participationintervention training sessions 1-8 (approximately 8 months)

    Range: Min/Max = 6 to 24 Internal assessment completed by the interventionist at the end of each training session.

  • Patient Global Impression of Change (PGIC) emotional functioning and quality of lifeimmediate post-treatment

    Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.

  • Care-partner Global Impression of Change (CGIC) emotional functioning and quality of lifeimmediate post-treatment

    Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.