Building Emotional Self-Awareness Teletherapy (BEST)

NCT ID: NCT05623046

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-23
• Study Completion Date: 2025-03-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes.

Group Type: EXPERIMENTAL

Treatment

Intervention Type: BEHAVIORAL

8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes

Interventions

Treatment

8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Intrepid Center of Excellence

FED

Sponsor Role: collaborator

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Flora Hammond

Chair of Department of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flora Hammond, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

W81XWH-22-2-0064

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15355

Identifier Type: -

Identifier Source: org_study_id