Recruiting

Emotional Training

Sponsor:

Hackensack Meridian Health

Code:

NCT07624825

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TREAT-A

TREAT-B

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

Study ID

NCT07624825

Start date

Jun 10, 2026

Status verified date

Jun, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Ineligibility and Attrition Rates [ Time Frame: Through study completion, an average of 8 months ]
  • Satisfaction Survey and Interview [ Time Frame: immediate post-treatment ]
  • Interventionist Evaluation of Session Participation [ Time Frame: intervention training sessions 1-8 (approximately 8 months) ]
  • Patient Global Impression of Change (PGIC) emotional functioning and quality of life [ Time Frame: immediate post-treatment ]
  • Care-partner Global Impression of Change (CGIC) emotional functioning and quality of life [ Time Frame: immediate post-treatment ]

Central Contacts and Locations

Central contacts

Grace Wells, BS

732-321-7000grace.wells1@hmhn.org

Locations

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Recruiting

Edison, New Jersey, United States, 08820

Contacts

Sarah Enock, BS

848-893-6577tbiresearchjfkjri@hmhn.org

Grace Wells, BS

732-321-7000grace.wells1@hmhn.org

Principal Investigator:

Dawn Neumann, PhD, FACRM

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Emotional Health Training
  • Severe Traumatic Brain Injury
  • Moderate Traumatic Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-06-23.