Reactions Event Appraisals and Context in TBI

F
Flora Hammond, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
50 participants needed
1 Location

Brief description of study

What is this study about?
Our primary objective is to provide new knowledge to better understand angry and aggressive reactions that persons with chronic traumatic brain injury (TBI) experience in response to events in their daily lives. This will be accomplished by examining the patterns of occurrence of angry and aggressive reactions that people with TBI have over two weeks, and associations of these reactions to contextual factors, personal characteristics, appraisals of real-life events, and emotion regulation behaviors using ecological momentary assessment (EMA). 
 
We are enrolling community-dwelling adults ≥10 months post-complicated mild to severe TBI who are participants in the Traumatic Brain Injury Model Systems (TBIMS)
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - All potential subjects for this study must be actively enrolled in their centers existing Traumatic Brain Injury Model Systems (TBIMS) study (for IU, IRB#1211010085). Participants at each center who have provided follow up data for the TBIMS National Database (NDB) may be eligible to be recruited. Recruitment and prescreening may occur in-person and/or via phone call and/or virtual visit during or after TBIMS study follow-up data collection. Respective site staff will contact potentially eligible participants about study participation.

Detailed description of study

What happens during the study?
If you agree to be in the study, you will do the following things. All study participation may be done remotely. You must have regular access to a portable device, such as a smartphone or tablet, with the ability to receive text messages and access the internet.
  • Baseline survey: You will complete a survey where you will answer questions about your emotions and mood. This will last approximately 25-30 minutes.

  • Baseline Assessment: You will read and watch different scenarios. You will be asked to interpret peoples’ emotions, thoughts, and intentions. This may be done via secure videoconference (e.g. Zoom) or in-person with a research assistant. This will last approximately 35 minutes. This may be combined with the study training.

  • Study training: We will demonstrate how you will complete daily study surveys. We will answer any questions and provide you a training guide. This may be done via secure videoconference (e.g. Zoom) or in-person with a research assistant. The training will last approximately 25 minutes. This may be combined with the baseline assessment.

  • Daily surveys: You will be prompted to complete a short survey via text 4 times daily for 14 days. These text messages will be sent to you by Twilio, a cloud based communication platform, and will include a direct link for you to complete the survey securely online on your smartphone. The survey will include questions about your recent activities, emotions, and mood. You should try to complete each survey as close to the time of receiving as possible. Each survey will remain active for one hour. You will receive a text reminder within the hour if you have not completed the survey.

    • Several days after starting the surveys and over the 14 days, study staff may contact you to check on how the surveys are going and ask if help is needed. 

  • End of Study survey: After you complete the daily surveys, you will receive a link to complete a one-time survey asking about your experience in the study. This survey will take about 10 minutes.

  • Exit interview: When your participation is complete, study staff may ask you to complete an interview to ask more about your experience responding to the daily surveys. This will take about 60 minutes. At the beginning of the interview, we will ask your permission to use automatic transcription software. This interview will not be audio or visually recorded. All identifying information would be removed from the transcript after the interview. 

  • We will use information you previously provided as a participant in the Traumatic Brain Injury Model Systems (TBIMS) study, including information about your demographics, injury, mental health, and independence completing daily activities.

  • You will be in this study for approximately one month. 

Eligibility of study

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

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

Inclusion criteria: 
  • Age >18 years at time of enrollment 
  • Community-dwelling NDB participants who have completed a TBIMS NDB follow-up assessment at any year and meet study eligibility.
  •  This study includes all TBIMS NDB participants able to engage in the study and meet eligibility criteria regardless of their current and past frustration and anger/aggression levels.
    • TBIMS NDB participation criteria are: ≥ 18 years old at injury; status post-complicated mild to severe TBI as defined by TBI with post-traumatic amnesia >24 hours, or loss of consciousness >30 minutes, Glasgow Coma Scale score in Emergency Department (ED)  
  • Willing and able to participate (have the comprehension, communication, sensorimotor function, and ability complete baseline intake survey, virtual/in-person EMA training, and EMA survey). This will be operationalized as the ability to complete TBIMS NDB data collection independently (without help from a proxy due to cognitive reasons) and self-reported ability to use a mobile phone to complete surveys. After consent, the participant’s abilities will also be confirmed via their ability to complete the baseline intake survey and their ability to per-form EMA during the research assistant (RA) EMA training session.
  • Authorization to receive text messages.
  •   English-speaking proficiency to be able to participate in assessments and EMA.
  •  Community dwelling.
  •  Has waking-hour access to and regular use of a portable device (e.g., smartphone) with cellular data service for receiving text messages via weblink.
  •   Has video webcam access to Internet connectivity or able to come in for in-person data collection and EMA training
     
Exclusion criteria:
o    Any other factor likely to interfere with safe, timely, and effective completion of the study in the judgement of the local investigator.
 

Updated on 28 Oct 2025. Study ID: PHMR-IIR-ACL-REACT, 21355
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only