Building Emotional Self-Awareness Teletherapy (BEST)

NCT05623046 | Completed DMC

• 2 other identifiers: 15355W81XWH-22-2-0064
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Alexithymia; Brain Injury; Concussion; Emotion Dysregulation; Affect; Resilience; Military; Service Members; Mood; Teletherapy

Outcome Measures

Primary Outcomes (1)

• Change in Toronto Alexithymia Scale-20 (TAS-20)

  This is a 20-item self report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher (worse) alexithymia). Subscales are summed to compute a total score.

  Baseline, Week 6, Week 12, Week 24

Secondary Outcomes (2)

• Change in Levels of Emotional Awareness Scale (LEAS)

  Baseline, Week 6, Week 12, Week 24

• Change in Difficulty with Emotion Regulation Scale (DERS)

  Baseline, Week 6, Week 12, Week 24

Other Outcomes (22)

• Change in Brief Resilience Scale (BRS)

  Baseline, Week 6, Week 12, Week 24

• Change in Positive and Negative Affect Schedule (PANAS)

  Baseline, Week 6, Week 12, Week 24

• Change in Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Week 6, Week 12, Week 24

Study Arms (1)

Treatment

EXPERIMENTAL

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

Behavioral: Treatment

Interventions

Treatment BEHAVIORAL

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild TBI (determined by Ohio State University TBI Identification Method)
• ≥18 years old
• ≥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.

You may not qualify if:

• 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)
• participants will be excluded if at any point, they participated in TREAT (in-person clinical trial of BEST - NCT03414463)

Sponsors & Collaborators

• Indiana University: lead
• National Intrepid Center of Excellence: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Brain Concussion; Syndrome; Affective Symptoms; Brain Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Flora Hammond, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 21, 2022
• Study Start: February 23, 2023
• Primary Completion: March 13, 2025
• Study Completion: March 25, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (1)