Traumatic Brain InjuryTREATNCT07624825
Emotional Awareness Therapy Study
A study testing TREAT-A and TREAT-B in people with Traumatic Brain Injury, run by Hackensack Meridian Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- TREAT-A and TREAT-B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
Edison, New Jersey, 08820
Sarah Enock, BS, 848-893-6577, tbiresearchjfkjri@hmhn.org
Grace Wells, BS, 732-321-7000 ext. 68682, grace.wells1@hmhn.org
About this study
Official title: 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.
Read more
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
- Being tested
- TREAT-A, TREAT-B
- Keywords
- Emotional Health Training, Severe Traumatic Brain Injury, Moderate Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREAT-ABehavioural
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-BBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TREAT-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediate post-treatment
Secondary outcomes (3)
Toronto Alexithymia Scale-20
Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)
Measured: 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)
Measured: 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
Measured: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start10 Jun 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn Neumann, PhD, FACRM, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624825
- Sponsor's protocol ID
- Pro2026-0081
- Acronym
- TREAT
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Exploring Emotional Health Training After Moderate to Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07624825
- Acronym / sponsor ID
- TREAT / Pro2026-0081
- Conditions
- Traumatic Brain Injury
- Keywords
- Emotional Health Training, Severe Traumatic Brain Injury, Moderate Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TREAT-A | Experimental | Behavioral: TREAT-AEight 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. |
| TREAT-B | Active comparator | Behavioral: TREAT-BProvides education on TBI and overall brain health through instructional sessions, discussion, and structured tasks geared towards living healthy and improving general well-being. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREAT-AThe 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. | Behavioural | TREAT-A |
| TREAT-BThe 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. | Behavioural | TREAT-B |
Primary outcome
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).
Satisfaction Survey and Interview
Time frame: immediate post-treatment
Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied
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.
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.
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.
3 secondary outcomes
Toronto Alexithymia Scale-20
Time frame: 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)
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Brief Resilience Scale
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dawn Neumann, PhD, FACRM principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TREAT-A and TREAT-B in people with Traumatic Brain Injury, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace Wells, BS (732-321-7000 ext. 68682, grace.wells1@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ineligibility and Attrition Rates (time frame: Through study completion, an average of 8 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.