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NCT Number: NCT07624825

Emotional Awareness Therapy Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Edison, New Jersey, 08820, United States

Location status: Recruiting

Location contact

Dawn Neumann, PhD, FACRM

PRINCIPAL_INVESTIGATOR

Grace Wells, BS

CONTACT

[email protected]

732-321-7000 ext. 68682

Sarah Enock, BS

CONTACT

[email protected]

848-893-6577

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TREAT-A

Behavioral

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

Behavioral

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 outcomes

  1. Ineligibility and Attrition Rates

    Time frame: Through 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).

  2. Satisfaction Survey and Interview

    Time frame: immediate post-treatment

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

  3. Interventionist Evaluation of Session Participation

    Time frame: intervention 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.

  4. Patient Global Impression of Change (PGIC) emotional functioning and quality of life

    Time frame: immediate post-treatment

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

  5. Care-partner Global Impression of Change (CGIC) emotional functioning and quality of life

    Time frame: immediate post-treatment

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

Secondary outcomes

  1. Toronto Alexithymia Scale-20

    Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.

    Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)

  2. Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)

    Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

    Range: Min/ Max = 36 to 180 Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)

  3. Brief Resilience Scale

    Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

    Range: Min/ Max = 6 to 30 Lower scores indicate worse resilience; higher scores indicate better resilience

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Wells, BS

CONTACT

[email protected]

732-321-7000 ext. 68682

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Official study title

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

Acronym: TREAT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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