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Recruiting NCT05623046

Building Emotional Self-Awareness Teletherapy (BEST)

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

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Indiana University

Location: United States

Summary

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.

Eligibility Criteria

Inclusion Criteria:Mild TBI (determined by Ohio State University TBI Identification Method)≥18 years old≥6 months post-TBIelevated alexithymia and emotion dysregulation (defined by >.5 standard deviation above means on the TAS-20 and DERS)capacity to consentproficient Englishif on medications that influence affect, must be stable for at least 6 weeksaccess 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 conditionvisual, hearing, communication, or cognitive impairments that would impede participationunstable or anticipated medication changes that will influence mood/ affect during study participationactive involvement in an intensive rehabilitation programindividuals 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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05623046). StuddyBuddy aggregates publicly available trial information.