Clinical trial NCT05623046: Building Emotional Self-Awareness Teletherapy (BEST)
Official title: Building Emotional Self-Awareness Teletherapy (BEST): a Tool to Optimize Psychological Health Outcomes for Persons with Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Intrepid Center of Excellence
name: Congressionally Directed Medical Research Programs
First posted: 2022-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Toronto Alexithymia Scale-20 (TAS-20)
timeFrame: Baseline, Week 6, Week 12, Week 24
Secondary outcomes:
measure: Change in Levels of Emotional Awareness Scale (LEAS)
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Change in Difficulty with Emotion Regulation Scale (DERS)
timeFrame: Baseline, Week 6, Week 12, Week 24
Other outcomes:
measure: Change in Brief Resilience Scale (BRS)
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Change in Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anger
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Change in Post-traumatic Stress Checklist- 5 (PCL-5)
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 12 and Week 24
measure: Post-treatment Satisfaction Survey
timeFrame: Week 12
measure: Change in Neurobehavioral Symptom Inventory (NSI)
timeFrame: Baseline, Week 12, Week 24
measure: Change in Phenotypes and exposures (PhenX) Mental Health Core Items: Alcohol Use and Substance Use
timeFrame: Baseline, Week 12, Week 24
measure: Change in Alcohol Use Disorders Identification Test (AUDIT-C)
timeFrame: Baseline, Week 12, Week 24
measure: Change in Drug Abuse Screen Test (DAST-10)
timeFrame: Baseline, Week 12, Week 24
measure: Change in Pain Catastrophizing Scale
timeFrame: Baseline, Week 12, Week 24
measure: Change in PROMIS Pain Intensity Short Form (3a)
timeFrame: Baseline, Week 12, Week 24
measure: Change in PROMIS Pain Interference (8a short form)
timeFrame: Baseline, Week 12, Week 24
measure: Change in Perth Alexithymia Questionnaire (PAQ)
timeFrame: Baseline, Week 12, Week 24
measure: Change in Ambivalence over Emotional Expressiveness Questionnaire (AEQ)
timeFrame: Baseline, Week 12, Week 24
measure: Change in Emotional Approach Coping (EAC)
timeFrame: Baseline, Week 12, Week 24
measure: Change in UPPS-P (Negative Urgency subscale only)
timeFrame: Baseline, Week 12, Week 24
measure: Change in Process Model of Emotion Regulation Questionnaire (PMERQ)
timeFrame: Baseline, Week 12, Week 24
measure: Change in Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Baseline, Week 12, Week 24
measure: Change in NIH Toolbox Loneliness
timeFrame: Baseline, Week 12, Week 24
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Flora Hammond, MD
role: PRINCIPAL_INVESTIGATOR
References: