Actively Recruiting
Clinical Trial to Evaluate the Efficacy of Building Emotional Self-awareness Teletherapy (BEST) at Improving Psychological Health in Service Members With Brain Injury
Led by Hackensack Meridian Health · Updated on 2026-05-22
300
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hackensack Meridian Health
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two different teletherapy training programs aimed at improving emotional health and well-being in people who have experienced a concussion or mild traumatic brain injury (mTBI). This study focuses on how these programs may help with emotional awareness and general well-being in adults who are at least 6 months post-injury. The study is conducted remotely and is designed to last about 8 months in total. Participants will be randomly assigned to one of two programs. Program 1 focuses on helping individuals recognize, label, and describe their emotions more clearly, aiming to reduce feelings of confusion, numbness, anger, stress, and being overwhelmed. Program 2 promotes overall well-being and quality of life by teaching self-management strategies and goal setting related to living with a brain injury. Both programs involve eight one-on-one training sessions delivered over approximately one month via secure video conferencing. During the study, participants will complete four assessment visits lasting about 30 to 90 minutes each. These assessments include surveys and questionnaires about emotional health and will take place before training, immediately after training, and at 3 and 6 months post-training. Researchers will measure outcomes such as emotional awareness, emotion regulation, resilience, depression, anxiety, anger, post-traumatic stress, and overall emotional functioning and quality of life. The study includes safety monitoring and aims to understand which program better supports psychological health after mTBI.
CONDITIONS
Brief Title
Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a mild traumatic brain injury
- Are 18 years old or older
- Injury occurred at least 6 months ago
- Have elevated difficulties with emotional awareness and emotion regulation
- Are able to provide consent
- Speak and understand English
- Have access to a personal device with internet and video conferencing capability
You will not qualify if you...
- Have a neurological disorder other than traumatic brain injury
- Have a degenerative neurological condition
- Have an active or uncontrolled major psychiatric disorder
- Are at risk of suicide or pose safety concerns to self or others
- Have visual, hearing, communication, or cognitive impairments that prevent participation
- Are on unstable medications or expect medication changes affecting mood during the study
- Are actively involved in an intensive rehabilitation program
- Recently started psychotherapy or mental health counseling within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the teletherapy program (exact length not specified)
Participants receive one of two teletherapy programs aimed at improving psychological health after brain injury. Program 1 focuses on enhancing emotional awareness and expression. Program 2 promotes general wellbeing and quality of life through self-management strategies.
Multiple teletherapy sessions conducted remotely
Duration - Up to 6 months post-treatment
Participants are assessed on psychological health outcomes at multiple time points after treatment completion.
3 follow-up assessments at immediate post-treatment, 3 months, and 6 months post-treatment
Trial Site Locations
Total: 3 locations
1
Indiana University
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
2
National Intrepid Center Of Excellence
Bethesda, Maryland, United States, 20889
Not Yet Recruiting
3
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
Edison, New Jersey, United States, 08820
Actively Recruiting
Research Team
G
Grace Wells
A
Amanda Melton
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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