Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury; Alexithymia
• Intervention / Treatment: Behavioral: Program 1; Behavioral: Program 2

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grace Wells; Phone Number: 68682 732-321-7000; Email: grace.wells1@hmhn.org
• Study Contact Backup: Name: Amanda Melton; Phone Number: 317-408-5589; Email: amamelto@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Not yet recruiting
      • Indiana University
      • Principal Investigator: Devan Parrott, PhD
      • Contact: Amanda Melton; Phone Number: 317-408-5589; Email: amamelto@iu.edu
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Not yet recruiting
      • National Intrepid Center Of Excellence
      • Contact: Treven Pickett, PsyD; Phone Number: 301-319-3670; Email: treven.c.pickett.civ@health.mil
      • Principal Investigator: Treven Pickett, PsyD
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • Recruiting
      • Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
      • Contact: Sarah Enock; Phone Number: 732-606-5034; Email: sarah.enock@hmhn.org
      • Principal Investigator: Dawn Neumann, PhD, FACRM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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.	1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Dawn Neumann, PhD, FACRM, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Concussion; Veterans; Brain training; Emotional dysregulation; Military service members
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Behavioral Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Behavior; Brain Concussion; Affective Symptoms
• Other Study ID Numbers: Pro2025-0403; HT94252510889 (Other Grant/Funding Number: Department of Defense Office of the Congressionally Directed Medical Research Programs)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No