Training to Reconnect With Emotional Awareness Therapy (NCT03414463) | Clinical Trial Compass
CompletedNot Applicable
Training to Reconnect With Emotional Awareness Therapy
United States44 participantsStarted 2018-05-08
Plain-language summary
To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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 Criteria:
* 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
What they're measuring
1
Change in Toronto Alexithymia Scale-20 (TAS-20)
Timeframe: Baseline Week , 6, 18, 30
2
Change in Levels of Emotional Awareness Scale (LEAS)