Training to Reconnect With Emotional Awareness Therapy

Indiana University44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Traumatic Brain Injury Alexithymia

Interventions

TREATBEHAVIORAL

A 4-week one-to-one intervention between the clinical RA (cRA) and participant. Comprised of eight sessions, it involves psycho-educational lessons and skill-building exercises to achieve objectives based on the characteristics of alexithymia.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Change in Toronto Alexithymia Scale-20 (TAS-20)

This is a 20-item self report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher alexithymia). Subscales are summed to compute a total score. Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia.

Time frame: Baseline Week , 6, 18, 30

Change in Levels of Emotional Awareness Scale (LEAS)

objective, performance-based measure of emotional awareness and labeling. Short hypothetical scenarios are presented and participants are asked to describe how they and others would feel in the context of the scenarios. Participants' responses are scored with an electronic system, removing human bias and interpretation. The LEAS has parallel forms (A and B), which will alternate at testing sessions.

Time frame: Baseline Week , 6, 18, 30

Secondary Outcomes

Difficulty with Emotion Regulation Scale (DERS)

Using a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. There are 6 subscales: Lack of Emotional Awareness, Lack of Emotional Clarity, Difficulties Controlling Impulsive Behaviors When Distressed, Difficulties Engaging in Goal-Directed Behavior When Distressed, Non-acceptance of Negative Emotional Responses, and Limited Access to Effective Emotion Regulation Strategies. Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, test-retest reliability, and good construct validity.61 Importantly, because this measure assesses difficulties regulating all types of emotions, it captures different information than that provided by measures specific to anxiety, anger, or depression which can miss more general, yet common, self-regulation problems.

Time frame: Baseline Week , 6, 18, 30

Generalized Anxiety Disorder Assessment (GAD-7):

Data from ClinicalTrials.gov

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