An interventional study of Program 1 and Program 2 in Mild Traumatic Brain Injury and Alexithymia, sponsored by Hackensack Meridian Health. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Hackensack Meridian Health · Not applicable, Interventional, and Treatment
Among 418 studies in Brain Concussion with a site in United States — 100 open to participants now, 121 under way, 5 of them phase 3. Brain Concussion · United States.
Among the 418 studies in Brain Concussion with a site in United States, this one is the 36th largest by planned enrollment of the 321 interventional ones, is one of 23 that started in 2026, is one of 264 with no phase, reaches primary completion later than 119 of the 120 other live ones, and was the 399th registered.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 300 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →100 of the 418 studies in Brain Concussion with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 112 Brain Concussion studies recruiting now, 33 (29%) set no upper age limit and 72 (64%) stop at 75 or younger; 24 take children under 18; 38 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →418 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 23 started in 2026.
Median enrollment 60 across the 321 interventional studies, 147 across the 96 observational. Of the 259 that completed or were terminated, 68 (26%) have results posted.
59 of 418 have an industry lead sponsor. The 10 most frequent:
Hackensack Meridian Health is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Hackensack Meridian Health has 1 study filed under Brain Concussion — fewer than ten, so there is no comparison to draw.
49 of the studies in Brain Concussion with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04867317Phase 3VA Office of Research and DevelopmentGrowth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) | 2027-02-28 |
| NCT05320822University of North Carolina, Chapel HillA Pragmatic Rehabilitation Intervention: The Active Rehab Study | 2026-11-28 |
| NCT06109909VA Office of Research and DevelopmentPilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury | 2026-11-30 |
| NCT02670161Endeavor HealthQuality Improvement and Practice Based Research in Neurology Using the EMR | 2026-12 |
| NCT04708613David Okonkwo, MD, PhDUniversity of Pittsburgh Brain Health Initiative | 2026-12 |
Among the 418 studies in Brain Concussion with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Program 1
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.
Behavioral: Program 2
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 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.
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)
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)
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)
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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.
Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
Started May 2026 (actual). Primary completion is estimated for Mar 2031, 58 months after the start.
Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 58 months is above that.
Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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