Clinical trial NCT03414463: Training to Reconnect With Emotional Awareness Therapy
Official title: Training to Reconnect With Emotional Awareness Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Alexithymia
Keywords: Brain Injury
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Toronto Alexithymia Scale-20 (TAS-20)
timeFrame: Baseline Week , 6, 18, 30
measure: Change in Levels of Emotional Awareness Scale (LEAS)
timeFrame: Baseline Week , 6, 18, 30
Secondary outcomes:
measure: Difficulty with Emotion Regulation Scale (DERS)
timeFrame: Baseline Week , 6, 18, 30
measure: Generalized Anxiety Disorder Assessment (GAD-7):
timeFrame: Baseline Week , 6, 18, 30
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline Week , 6, 18, 30
measure: State-Trait Anger Expression Inventory (STAXI)
timeFrame: Baseline Week , 6, 18, 30
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline Week , 6, 18, 30
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 6 or 18 depending on randomization
measure: Caregiver Global Impression of Change (CaGIC)
timeFrame: Week 6, 18, 30
measure: Participant Satisfaction
timeFrame: Week 6 or 18 depending on randomization
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
affiliation: Indiana University
name: Flora Hammond, MD
role: PRINCIPAL_INVESTIGATOR
References: