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Emotional Awareness Therapy for Traumatic Brain Injury (TREAT Trial)
TREAT Trial Summary
This trial is testing whether treating alexithymia can help improve emotional self-regulation.
- Traumatic Brain Injury
- Alexithymia
TREAT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TREAT Trial Design
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Who is running the clinical trial?
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- You have a neurological condition like Alzheimer's or Parkinson's disease that could affect your mood and thinking, but not including controlled seizures.You have been diagnosed with a serious mental illness like schizophrenia or Borderline Personality Disorder.You have severe depression and may be a danger to yourself or others.You have a developmental disability like autism or developmental delay.You started seeing a therapist less than 4 weeks ago.Currently taking part in the Traumatic Brain Injury Model System (TBIMS) study related to alexithymia.You have a traumatic brain injury caused by a physical force.You have had a head injury with specific symptoms like loss of consciousness or certain findings on a head CT scan.At least 1 year has passed since the injury occurred.You have a moderate to high score on a test that measures difficulty in expressing emotions.You have had a traumatic brain injury from a physical force.You have experienced a traumatic brain injury with specific symptoms or test results.
- Group 1: Waitlist Control
- Group 2: TREAT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the intended outcomes of this investigation?
"The principal outcome to be evaluated in this clinical trial, over Baseline Week , 6, 18, and 30 is the Change in Levels of Emotional Awareness Scale (LEAS). Secondary outcomes include Positive and Negative Affect Scale (PANAS), which utilises a 20-item survey to assess one's mood on a five point scale; Caregiver Global Impression of Change (CaGIC) – an evaluation by caregivers that ranks participant progress from 1 ("very much worse") to 7 ("very much improved"); as well as Patient Global Impression of Change (PGIC), where patients rate their own improvement."
What is the population size of this investigation?
"Affirmative, the trial is still recruiting. According to clinicaltrials.gov data, this particular research study was initially posted on May 8th 2018 and has recently been updated on May 24th 2022. At present, 44 participants are required from one medical site for inclusion in this experiment."
Is recruitment still open for this research study?
"This investigation is currently recruiting participants, as reported on clinicaltrials.gov. It was first advertised in May of 2018 and the latest update was issued at the end of May 2022."
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