Building Emotional Self-Awareness Teletherapy (BEST)

Indiana University

Status

Completed

Conditions

Alexithymia

Concussion, Severe

Concussion with Brief Loss of Consciousness

Concussion, Intermediate

Concussion Injury of Cerebrum

Concussion, Mild

Concussion; Syndrome

Concussion, Brain

Treatments

Behavioral: Treatment

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT05623046

W81XWH-22-2-0064 (Other Grant/Funding Number)

15355

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)
participant behaviors that cause concern for their ability to participate in accordance with the study requirements and protocol (e.g., unreliable correspondences, no-shows, no-replies to multiple contacts, habitual rescheduling, unable to complete study requirements in timely manner)
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)