Concussion, MildBESTNCT05623046
Building Emotional Self-Awareness Teletherapy (BEST)
A study testing Treatment in people with Concussion, Mild and Concussion, Brain, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concussion, Mild, Concussion, Brain, Concussion, Severe
- What is being tested?
- Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2023to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Emotional Self-Awareness Teletherapy (BEST): a Tool to Optimize Psychological Health Outcomes for Persons with Traumatic Brain Injury
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.
Read the 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
- Being tested
- Treatment
- Keywords
- Alexithymia, Brain Injury, Concussion, Emotion Dysregulation, Affect, Resilience, Military, Service Members, Mood, Teletherapy
- Medical subject headings
- Brain Concussion, Syndrome, Affective Symptoms, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentBehavioural
8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes. Receives: Behavioral: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6, Week 12, Week 24
Secondary outcomes (2)
Change in Levels of Emotional Awareness Scale (LEAS)
Objective, performance-based measure of emotional awareness and labeling. Short hypothetical scenarios are presented and participants are asked to describe how they and others would feel in the context of the scenarios. More discrete emotions earn more points (e.g., "sad" scores better than "bad"). Participants' responses are scored with an electronic system, removing human bias and interpretation. The LEAS has parallel forms (A and B), which will alternate at testing sessions.
Measured: Baseline, Week 6, Week 12, Week 24
Change in Difficulty with Emotion Regulation Scale (DERS)
Using a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. There are 6 subscales: Lack of Emotional Awareness; Lack of Emotional Clarity; Difficulties Controlling Impulsive Behaviors when Distressed; Difficulties Engaging in Goal-Directed Behavior when Distressed; Non-acceptance of Negative Emotional Responses; and Limited Access to Effective Emotion Regulation Strategies. Items are summed to provide a Total Emotion Dysregulation score. Scores range from 5 (low) to 180 (high). Higher scores are indicative of more emotion dysregulation problems. The DERS has high internal consistency, test-retest reliability, and good construct validity.
Measured: Baseline, Week 6, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start23 Feb 2023
- Primary completion13 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Intrepid Center of Excellence, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Flora Hammond, Indiana University
- Investigators
- Flora Hammond, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623046
- Sponsor's protocol ID
- 15355
- Other IDs
- W81XWH-22-2-0064
- Acronym
- BEST
- Status last verified
- Mar 2025
- First submitted
- 14 Nov 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Emotional Self-Awareness Teletherapy (BEST): a Tool to Optimize Psychological Health Outcomes for Persons with Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05623046
- Acronym / sponsor ID
- BEST / 15355
- Conditions
- Concussion, Mild, Concussion, Brain, Concussion, Severe, Concussion, Intermediate, Concussion; Syndrome, Concussion Injury of Cerebrum
- Keywords
- Alexithymia, Brain Injury, Concussion, Emotion Dysregulation, Affect, Resilience, Military, Service Members
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Intrepid Center of Excellence, Congressionally Directed Medical Research Programs
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Treatment8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes | Behavioural | Treatment |
Primary outcome
Change in Toronto Alexithymia Scale-20 (TAS-20)
Time frame: Baseline, Week 6, Week 12, Week 24
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.
2 secondary outcomes
Change in Levels of Emotional Awareness Scale (LEAS)
Time frame: Baseline, Week 6, Week 12, Week 24
Change in Difficulty with Emotion Regulation Scale (DERS)
Time frame: Baseline, Week 6, Week 12, Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flora Hammond, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Concussion, Mild and Concussion, Brain, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Toronto Alexithymia Scale-20 (TAS-20) (time frame: Baseline, Week 6, Week 12, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.