Training to Reconnect With Emotional Awareness Therapy



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:5/16/2018
Start Date:May 8, 2018
End Date:December 31, 2022
Contact:Ryan Mayfield, BS
Email:interfac@iu.edu
Phone:317-329-2380

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To decrease emotional self-awareness deficits and improve emotional self-regulation,
particularly anxiety, anger, depression, and positive affect, through the treatment of
alexithymia.

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 anticipated that our target sample size is 44. The purpose of this study
is to examine differences in post-treatment self-reported alexithymia and emotional
self-awareness in participants with TBI randomized to TREAT or WLC. In addition to examining
the differences in post-treatment self-reported emotion regulation (general), anxiety, anger,
depression, positive affect (PA), global emotional function and quality of life in
participants with TBI randomized to TREAT or WLC.

Inclusion Criteria:

- 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

- have moderate to high screening alexithymia score (TAS-20 ≥52).

Exclusion Criteria:

- diagnosed with pre-morbid neurological disorder (e.g., stroke, autism, developmental
delay)

- diagnosed with major psychiatric disorder (e.g., schizophrenia)

- diagnosed with a degenerative neurologic condition

- unable to follow directions; visual or hearing impairments that would impede
participation

- unable to communicate verbally

- unstable or anticipated medication changes during study participation

- active psychological treatment; or actively participating in the Traumatic Brain
Injury Model System (TBIMS) alexithymia outcome module
We found this trial at
1
site
Indianapolis, Indiana 46254
Phone: 317-329-2035
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