Clinical Trial to Compare the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People with Brain Injury
Devan Parrott
Primary Investigator
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
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Age: 18 years - 100 years
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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
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