Building Emotional Self-Awareness Teletherapy (BEST) (NCT05623046) | Clinical Trial Compass
CompletedNot Applicable
Building Emotional Self-Awareness Teletherapy (BEST)
United States40 participantsStarted 2023-02-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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)
* 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…