Clinical Trial to Compare the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People with Brain Injury

Study on Teletherapy Programs for Emotional Health in Brain Injury

D
Devan Parrott

Primary Investigator

Recruiting
18 years - 100 years
All
Phase N/A
38 participants needed
1 Location

Brief description of study

Researchers at Indiana University School of Medicine are looking for adults with concussion or mild traumatic brain injury (mTBI) to find out if a training program can help people have better emotional health and well-being.

Detailed description of study

What the study involves (all done virtually):

Assessment 1/Screening (~60-90 minutes): This visit will include questionnaires/surveys that cover the following: demographics, medical history, emotional health and overall well-being. Information will be collected via interviews and electronic surveys.

The remaining activities are only for eligible participants.

Randomization: You will be randomly assigned to one of two training programs. Randomization is a process like flipping a coin and means you will have a change of being assigned to either of the training programs. Program 1 will teach you how to recognize, label and differentiate your emotions. Program 2 will teach you strategies to improve your overall brain health and functioning.

Training: This starts approximately 1-2 weeks after Assessment 1. There will be 8 training sessions. Ideally, these sessions will occur twice a week (approximately 1 month of training). However, flexibility will be allowed to accomodate your schedule.

  • Training sessions will be delivered remotely using secure videoconferencing.
  • Training sessions will last approximately 60-90 minutes.
  • Sessions will be one-on-one with a trained staff member.
  • Sessions incorporate a variety of interactive lessons and activities that will be used as a basis for discussion. Some sessions may be audio-recorded. We will notify you before recording begins.

Assessments 2, 3, and 4 (all ~30-60 minutes) will take place approximately 1 week, 3 months, and 6 months after your last training session. Most of the surveys will be the same as Assessment 1. 

If you are eligible, your participation will last approximately 8 months.

 

Why consider participating?

  • You may improve your emotional health and well-being.
  • You will help contribute to knowledge needed to achieve better outcomes for people with a brain injury.
  • You will support the development of tools to achieve better mental health outcomes for people with a brain injury, including service members and veterans.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mild Traumatic Brain Injury, TBI
  • Age: 18 years - 100 years
  • Gender: All

You may be eligible for this study if you meet the following criteria: 
•   Are 18 years or older
•   Have had a concussion or mild traumatic brain injury (mTBI) at least 6 months ago (or longer)
•   Have access to a computer or tablet capable of videoconferencing

Online study

This study investigates teletherapy programs aimed at improving emotional health in people with mild traumatic brain injury (mTBI). mTBI is a type of brain injury that can affect emotional awareness and regulation. The study compares two teletherapy programs: Building Emotional Self-awareness Teletherapy (BEST) and Brain Health Guidance (BHG), involving about 152 participants, including veterans and civilians.

Participants will be randomly assigned to either the BEST or BHG study arm. The study will measure emotional awareness, emotion regulation, and psychological health outcomes immediately, and at three and six months after treatment. Participants will use their personal devices to access the teletherapy sessions.

  • Who can participate: Participants must be 18 years or older, have had a mild traumatic brain injury at least six months ago, and have difficulties with emotional awareness and regulation.
  • Study details: Participants will engage in teletherapy sessions using their personal devices. They will be assigned to one of two study arms: BEST or BHG, and will complete assessments on emotional and psychological health at specified intervals.
Updated on 20 May 2026. Study ID: PHMR-IIR-TIPS, 29112

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