Building Emotional Self-Awareness Teletherapy (BEST)

Study Overview
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Brief Summary
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To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered intervention for civilians and service members with mild traumatic brain injury (mTBI) who have difficulty recognizing and regulating their emotions. Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms.

Detailed Description
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This Phase I proof of principle pilot study of the Building Emotional Self-awareness Teletherapy (BEST) intervention will use a quasi-experimental, non-randomized, one-group pretest-posttest design with a double pretest and a 3-month follow-up in approximately 40 participants with mTBI ( 20 civilians and  20 service members). Study objectives are to explore the feasibility and early efficacy of BEST to improve psychological health outcomes in civilian and Service Member (SM) participants with mTBI who have alexithymia (poor emotional self-awareness) and emotion dysregulation. We anticipate BEST will have good feasibility and acceptability in both civilian and service member participants, and post-treatment assessments will show significant improvements in alexithymia, emotion regulation, resiliency, and affective symptoms.

Official Title
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Building Emotional Self-Awareness Teletherapy (BEST): A Tool to Optimize Psychological Health Outcomes for Persons With Traumatic Brain Injury

Conditions
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Concussion, Severe, Concussion, Mild, Concussion, Brain, Concussion, Intermediate, Concussion; Syndrome, Concussion Injury of Cerebrum, Concussion With Brief Loss of Consciousness, Alexithymia

Intervention / Treatment
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* Behavioral: Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild TBI (determined by Ohio State University TBI Identification Method) ≥18 years old U.S. resident (exclusion for California residents) ≥6 months post-TBI elevated alexithymia and emotion dysregulation (defined by >.5 standard deviation above means on the TAS-20 and DERS) capacity to consent proficient English if on medications that influence affect, must be stable for at least 6 weeks access to a device capable of video conferencing and high speed internet. Exclusion Criteria: Premorbid neurological disorder other than TBI (e.g., stroke), active or uncontrolled major psychiatric disorder and/ or disorder that would pose a safety concern (e.g., borderline personality disorder) degenerative neurologic condition visual, hearing, communication, or cognitive impairments that would impede participation unstable or anticipated medication changes that will influence mood/ affect during study participation active involvement in an intensive rehabilitation program individuals who recently started psychotherapy (e.g., < 3 months ago) concurrent participation in any other clinical trial that aims to improve mood/ behavioral functioning will be an exclusion criterion. participants will be excluded if at any point, they participated in TREAT (in-person clinical trial of BEST - NCT03414463)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes. | Behavioral: Treatment<br>* 8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (worse) alexithymia). Subscales are summed to compute a total score. | Baseline, Week 6, Week 12, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. More discrete emotions earn more points (e.g., sad scores better than bad). 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. | Baseline, Week 6, Week 12, Week 24 | 
| Change in 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. Scores range from 5 (low) to 180 (high). Higher scores are indicative of more emotion dysregulation problems. The DERS has high internal consistency, test-retest reliability, and good construct validity. | Baseline, Week 6, Week 12, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alexithymia, Brain Injury, Concussion, Emotion Dysregulation, Affect, Resilience, Military, Service Members, Mood, Teletherapy