Mild Traumatic Brain InjuryNCT07436754
Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury
A study testing Program 1 and Program 2 in people with Mild Traumatic Brain Injury and Alexithymia, run by Hackensack Meridian Health at 3 sites in United States.
Trial summary
The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury, Alexithymia
- What is being tested?
- Program 1 and Program 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2026to Mar 2031
- 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
- Mild TBI
- ≥18 years old
- ≥6 months post-TBI
- Elevated alexithymia and emotion dysregulation
- Capacity to consent
- Speaks and understands English
- Personal device capable of video conferencing and internet
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
- Previous psychiatric hospitalization
- Visual, hearing, communication, or cognitive impairments that would impede participation
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- Unstable medications (e.g., started < 6 weeks prior to enrollment) or anticipated medication changes that will influence mood/ affect during study participation
- Active involvement in an intensive rehabilitation program
- Individuals who recently started psychotherapy and/or mental health counseling (e.g., <3 months prior)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
National Intrepid Center Of Excellence
Bethesda, Maryland, 20889
Treven Pickett, PsyD, 301-319-3670, treven.c.pickett.civ@health.mil
Treven Pickett, PsyD
- Recruiting
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
Edison, New Jersey, 08820
Sarah Enock, 732-606-5034, sarah.enock@hmhn.org
Dawn Neumann, PhD, FACRM
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Amanda Melton, 317-408-5589, amamelto@iu.edu
Devan Parrott, PhD
About this study
Official title: Clinical Trial to Evaluate the Efficacy of Building Emotional Self-awareness Teletherapy (BEST) at Improving Psychological Health in Service Members With Brain Injury
The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.
- Conditions
- Mild Traumatic Brain Injury, Alexithymia
- Being tested
- Program 1, Program 2
- Keywords
- Emotional dysregulation, Brain training, Concussion, Veterans, Military service members
- Medical subject headings
- Brain Concussion, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program 1Behavioural
Program 1 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.
Program 2Behavioural
Program 2 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 |
|---|---|---|
| Program 1 | Experimental | Enhance emotional awareness and ability to name, describe and express emotions with greater clarity, granularity and accuracy. Goals include enhancing participants' ability to: recognize and embrace the benefits of emotional awareness; detect onset of emotional responses early before escalation; accurately label and differentiate emotions; discern emotions from non-emotions; recognize and experience a larger breadth of emotions, including pleasant emotions. Receives: Behavioral: Program 1 |
| Program 2 | Active comparator | To promote general wellbeing and quality of life. Grounded in Health Belief Model emphasizing self-management and self-efficacy. Content includes topics relevant to living health with a TBI Contents were derived from the Traumatic Brain Injury Model Systems Knowledge Translation Center factsheets and topics recommended by the Consumer advisory panel. Receives: Behavioral: Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Alexithymia Scale-20
his widely used alexithymia assessment (including the TBI population), is comprised of 3 factors: 1) ability to identify emotions); 2) ability to describe emotions; and 3) externally-oriented thinking. In addition to being a co-primary outcome measure, the TAS-20 scores will be used to determine eligibility (>.5 SD above published means). It is a CDE and a PhenX toolkit measure has good psychometric properties, including good test-retest reliability. 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)
This commonly used measure of emotion dysregulation, uses a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, test-retest reliability, and good construct validity.56 Will be used to evaluate emotion dysregulation and to determine eligibility (>.5 SD above published means). 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
Secondary outcomes (6)
Brief Resilience Scale (BRS)
Self-administered questionnaire with 6 items using a 5-point Likert-style scale to assess the ability to bounce back or recover from stress. Scores range from 6-30. The BRS is a recommended CDE in the PhenXToolkit and has been found to have good reliability and validity. 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
Patient Health Questionnaire-9 (PHQ-9; depression)
This 9 item self-report depression assessment uses a 3-point Likert scale with established validity and reliability, including in the TBI population.64,65 Participants rate the frequency of specified problems during the past 2 weeks. Range: Min/ Max = 0 to 27 Lower scores indicate less depression; higher scores indicate higher depression
Measured: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
PROMIS item banks for Anxiety
The PROMIS item bank (8a) for anxiety is 8 items and the Anger item bank (5a) includes 5 items. The Anxiety instrument measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). All use a 5-point Likert scale, ranging from never to always. These are Common Data Elements (CDE) measures and have good psychometric properties. Range: Min/ Max = 8 to 40 Lower scores indicate less anxiety; higher scores indicate higher anxiety
Measured: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
PROMIS item banks Anger
The PROMIS Anger instrument assesses self-reported angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. All use a 5-point Likert scale, ranging from never to always. These are Common Data Elements (CDE) measures and have good psychometric properties. Range: Min/ Max = 5 to 25 Lower scores indicate less anger; high scores indicate more anger
Measured: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Post-traumatic Stress Checklist- 5 (PCL-5)
PCL-5 is used to measure PTSD symptomatology. The PCL-5 is a 20-item, self-rating scale that provides a quick and accurate measure of PTSD symptoms. Each item corresponds to current diagnostic criteria of PTSD, and each symptom is rated in terms of frequency and severity. The PCL-5 is applied generally to any traumatic event and therefore would capture any military-specific trauma. Psychometric properties indicate the PCL to be a valid instrument of PTSD symptoms. Range: Min/ Max = 0 to 80. Lower scores indicate less posttraumatic stress; high scores indicates greater post-traumatic stress
Measured: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Patient Global Impression of Change (PGIC) emotional functioning and quality of life
The PGIC captures the patient perspective regarding the achievement of clinically important change with a single item asking perception of change across a rating scale ranging from 1 (no change) to 7 (a great deal better and a considerable improvement). Two separate PGIC assessments will be administered to participants immediately (within a week)- one to evaluate perceived change in global emotional functioning/ PH (PGIC-Emotion) and the other to evaluate perceived global changes in quality of life (PGIC-QoL). In addition to the traditional 7-point rating scale, participants will also be asked to provide a list of changes (if any) in their emotional functioning and psychological health for the PGIC-emotion, and to list any changes in their life quality for the PGIC-QoL. This "Free listing" will have participants list all the items, concepts, or ideas that come to mind regarding their global changes.
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 posted27 Feb 2026
- Study start20 May 2026
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Dawn Neumann, PhD, FACRM, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436754
- Sponsor's protocol ID
- Pro2025-0403
- Other IDs
- HT94252510889
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2026
- Last updated
- 12 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy of Building Emotional Self-awareness Teletherapy (BEST) at Improving Psychological Health in Service Members With Brain Injury
- ClinicalTrials.gov ID
- NCT07436754
- Acronym / sponsor ID
- Pro2025-0403
- Conditions
- Mild Traumatic Brain Injury, Alexithymia
- Keywords
- Emotional dysregulation, Brain training, Concussion, Veterans, Military service members
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 20 May 2026 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 27 Feb 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 the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program 1 | Experimental | Behavioral: Program 1Enhance emotional awareness and ability to name, describe and express emotions with greater clarity, granularity and accuracy. Goals include enhancing participants' ability to: recognize and embrace the benefits of emotional awareness; detect onset of emotional responses early before escalation; accurately label and differentiate emotions; discern emotions from non-emotions; recognize and experience a larger breadth of emotions, including pleasant emotions. |
| Program 2 | Active comparator | Behavioral: Program 2To promote general wellbeing and quality of life. Grounded in Health Belief Model emphasizing self-management and self-efficacy. Content includes topics relevant to living health with a TBI Contents were derived from the Traumatic Brain Injury Model Systems Knowledge Translation Center factsheets and topics recommended by the Consumer advisory panel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Mild TBI
- ≥18 years old
- ≥6 months post-TBI
- Elevated alexithymia and emotion dysregulation
- Capacity to consent
Key exclusion criteria (9 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
- Previous psychiatric hospitalization
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 |
|---|---|---|
| Program 1Program 1 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 | Program 1 |
| Program 2Program 2 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 | Program 2 |
Primary outcome
Toronto Alexithymia Scale-20
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.
his widely used alexithymia assessment (including the TBI population), is comprised of 3 factors: 1) ability to identify emotions); 2) ability to describe emotions; and 3) externally-oriented thinking. In addition to being a co-primary outcome measure, the TAS-20 scores will be used to determine eligibility (>.5 SD above published means). It is a CDE and a PhenX toolkit measure has good psychometric properties, including good test-retest reliability. Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)
Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
This commonly used measure of emotion dysregulation, uses a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, test-retest reliability, and good construct validity.56 Will be used to evaluate emotion dysregulation and to determine eligibility (>.5 SD above published means). Range: Min/ Max = 36 to 180. Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)
6 secondary outcomes
Brief Resilience Scale (BRS)
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Patient Health Questionnaire-9 (PHQ-9; depression)
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
PROMIS item banks for Anxiety
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
PROMIS item banks Anger
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Post-traumatic Stress Checklist- 5 (PCL-5)
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Patient Global Impression of Change (PGIC) emotional functioning and quality of life
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 12 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program 1 and Program 2 in people with Mild Traumatic Brain Injury and Alexithymia, run by Hackensack Meridian Health at 3 sites 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 9 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 12 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 3 sites 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 (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?
Toronto Alexithymia Scale-20 (time frame: 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.). The study lists 2 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 12 Jun 2026.