Status:
COMPLETED
Training to Reconnect With Emotional Awareness Therapy
Lead Sponsor:
Indiana University
Conditions:
Traumatic Brain Injury
Alexithymia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.
Detailed Description
Phase II randomized, Waitlist Control (WLC) trial with 3-month follow-up to further establish proof of concept and early efficacy of TREAT (1:1 alexithymia treatment) for post-TBI alexithymia. It is a...
Eligibility Criteria
Inclusion
- TBI (injury due to a external physical force)
- Complicated mild, moderate, or severe TBI (defined by Glasgow Coma Scale (GCS) in Emergency Department (ED) (≤12), or Post traumatic amnesia (PTA) (≥1 day),Loss of Conscientious (LOC) (≥30 minutes),or positive head CT scan consistent with TBI)
- At least 18 years or older
- ≥1 year post-injury
- Adequate vision, hearing, speech, and comprehension
- Reliable mode of transportation
- Available for treatment during regular business hours
- Have moderate to high screening alexithymia score (TAS-20 ≥52)
- If participating in active psychological treatment prior to enrollment, their participation must be ongoing for 4 or more weeks
Exclusion
- Diagnosed with pre-morbid neurological disorder that could affect mood and cognition (e.g., stroke, Alzheimer's disease, Parkinson's disease); does not include controlled seizures
- Diagnosed with major psychiatric disorder (e.g., schizophrenia, Borderline Personality Disorder)
- Severe Depression and/or perceived risk to self or others
- Developmental disability (e.g. autism, developmental delay)
- Unstable or anticipated medication changes related to mood or emotion during study participation
- Having started psychological treatment less than 4 weeks prior to enrollment
- Actively participating in the Traumatic Brain Injury Model System (TBIMS) alexithymia outcome module
Key Trial Info
Start Date :
May 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03414463
Start Date
May 8 2018
End Date
November 14 2023
Last Update
May 20 2024
Active Locations (1)
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1
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254