Emotional Awareness Therapy Study

NCT07624825 | Not Yet Recruiting

• 1 other identifier: Pro2026-0081
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Toronto Alexithymia Scale-20

  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)

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

• Brief Resilience Scale

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

Study Arms (2)

TREAT-A

EXPERIMENTAL

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

TREAT-B

ACTIVE COMPARATOR

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

Interventions

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-A

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.

TREAT-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Edison, New Jersey, 08820, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Dawn Neumann, PhD, FACRM

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Wells, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized design, participants who \<12 months post TBI will be sequentially and alternatively assigned to either TREAT-A or TREAT-B programs; participants 12+ months post TBI will also be sequentially and alternatively assigned to either TREAT-A or TREAT-B programs.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

US (1)