Emotional Awareness Therapy Study (TREAT)

A Feasibility Study Exploring Emotional Health Training After Moderate to Severe Traumatic Brain Injury

The purpose of this study is to learn about the potential benefits of two different training programs in helping improve emotional health and well-being in people who have had a traumatic brain injury.

Participants will be assigned to one of two programs based on the time since their injury. One of the programs will teach participants how to recognize and label emotions; the other will teach healthy ways of living. Participants may improve their emotional well-being and contribute to the knowledge needed to achieve better emotional health outcomes for people with TBI.

For eligible participants, the study includes 4 assessments. Assessments may take 30-60 minutes and will be done using secure videoconferencing, phone calls, and/or electronic surveys. The first assessment will ask questions about demographics, the participant's brain injury, and some medical history. All assessments will include questions about emotions, emotional awareness, resilience, loneliness, and how participants manage emotions, in addition to broader wellness questions and questions about how participants interact with others.

Regardless of the program, the training includes 8 one-on-one sessions with a trained staff member over the course of about 1 month. Each session will last approximately 60-90 minutes. These sessions will start shortly after completing the first assessment. Preferably, participants will complete 1-2 training sessions a week, depending on availability and preference. These sessions will include education, discussion, and practice exercises.

After the program is finished, participants will be asked to complete the same surveys completed at baseline for three follow-up time points (immediately following the program, 3 months after the program, and 6 months after). Total participation in the study will last approximately 8 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: TREAT-A; Behavioral: TREAT-B

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grace Wells, BS; Phone Number: 68682 732-321-7000; Email: grace.wells1@hmhn.org

Study Locations

• United States
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
      • Principal Investigator: Dawn Neumann, PhD, FACRM
      • Contact: Grace Wells, BS; Phone Number: 68682 732-321-7000; Email: grace.wells1@hmhn.org
      • Contact: Sarah Enock, BS; Phone Number: 848-893-6577; Email: tbiresearchjfkjri@hmhn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TREAT-A; 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.	Behavioral: TREAT-A; The TREAT-A program will teach participants how to recognize, label, and differentiate their emotions. The program will cover ways to reduce feeling "confused" or numb, and decrease the feelings of anger, stress and being overwhelmed.
Active Comparator: TREAT-B; Provides education on TBI and overall brain health through instructional sessions, discussion, and structured tasks geared towards living healthy and improving general well-being.	Behavioral: TREAT-B; The TREAT-B program will teach participants strategies to improve their overall brain health and functioning. It will also teach participants how to develop and work towards individualized short-term and long-term goals aimed at improving their quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ineligibility and Attrition Rates	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).	Through study completion, an average of 8 months
Satisfaction Survey and Interview	Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied	immediate post-treatment
Interventionist Evaluation of Session Participation	Range: Min/Max = 6 to 24 Internal assessment completed by the interventionist at the end of each training session.	intervention training sessions 1-8 (approximately 8 months)
Patient Global Impression of Change (PGIC) emotional functioning and quality of life	Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.	immediate post-treatment
Care-partner Global Impression of Change (CGIC) emotional functioning and quality of life	Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.	immediate post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toronto Alexithymia Scale-20	Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)	1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.
Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)	Range: Min/ Max = 36 to 180 Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)	1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Brief Resilience Scale	Range: Min/ Max = 6 to 30 Lower scores indicate worse resilience; higher scores indicate better resilience	1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Investigators: Principal Investigator: Dawn Neumann, PhD, FACRM, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Severe Traumatic Brain Injury; Moderate Traumatic Brain Injury; Emotional Health Training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: Pro2026-0081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No