Recruiting

Brain Training Programs

Sponsor:

Hackensack Meridian Health

Code:

NCT07436754

Conditions

Mild Traumatic Brain Injury

Alexithymia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Program 1

Program 2

Study Details

Brief 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. 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

Study ID

NCT07436754

Start date

May 20, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2031

Anticipated

Primary completion date

Mar, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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
  • Previous psychiatric hospitalization
  • Visual, hearing, communication, or cognitive impairments that would impede participation
  • 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)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Program 1

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.

active comparator: Program 2

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.

Interventions

Program 1

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

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.

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. ]
  • Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome) [ Time Frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months ]

Central Contacts and Locations

Central contacts

Grace Wells

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

Amanda Melton

317-408-5589amamelto@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Amanda Melton

317-408-5589amamelto@iu.edu

Principal Investigator:

Devan Parrott, PhD

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Recruiting

Edison, New Jersey, United States, 08820

Contacts

Sarah Enock

732-606-5034sarah.enock@hmhn.org

Principal Investigator:

Dawn Neumann, PhD, FACRM

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Emotional dysregulation
  • Brain training
  • Concussion
  • Veterans
  • Military service members

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-06-12.