NCT05623046

Building Emotional Self-Awareness Teletherapy (BEST)

Building Emotional Self-Awareness Teletherapy (BEST): a Tool to Optimize Psychological Health Outcomes for Persons with Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Concussion, Mild
• Concussion, Brain
• Concussion, Severe
• Concussion, Intermediate
• Concussion; Syndrome
• Concussion Injury of Cerebrum
• Concussion with Brief Loss of Consciousness
• Alexithymia

Interventions

Type	Name	Description
BEHAVIORAL	Treatment	8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes

Timeline

• Start date: 2023-02-23
• Primary completion: 2025-03-13
• Completion: 2025-03-25
• First posted: 2022-11-21
• Last updated: 2025-04-01

Locations

1 site across 1 country: United States