Menu
Recruiting NCT07436754

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

No phase Interventional Mild Traumatic Brain Injury Alexithymia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Program 1, Program 2.
Who it may be relevant to
Registry conditions: Mild Traumatic Brain Injury, Alexithymia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Indiana University — Indianapolis
  • National Intrepid Center Of Excellence — Bethesda
  • Hackensack Meridian Health - JFK Johnson Rehabilitation Institute — Edison

Identifiers

NCT: NCT07436754 · Pro2025-0403 · HT94252510889

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗