BEST Teletherapy for Traumatic Brain Injury

(BEST Trial)

Overseen By Rebecca Runkel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Neurological disorder, Major psychiatric, Degenerative neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new teletherapy program for individuals who have experienced a mild traumatic brain injury (mTBI) and face challenges in recognizing and managing their emotions. The treatment, Building Emotional Self-Awareness Teletherapy (BEST), consists of eight online therapy sessions designed to enhance emotional awareness and control, increase resilience, and reduce mood-related symptoms. Participants should have experienced a mild TBI at least six months prior and require support with emotion regulation. As an unphased trial, this study provides a unique opportunity to access innovative therapy and contribute to understanding its benefits for emotional regulation.

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but they must be stable for at least 6 weeks if they affect your mood or emotions. If your medications are unstable or you expect changes that could affect your mood, you may not be eligible for the trial.

What prior data suggests that this teletherapy is safe for individuals with mild traumatic brain injury?

Research shows that Building Emotional Self-Awareness Teletherapy (BEST) aims to help individuals with mild traumatic brain injury (mTBI) enhance their emotional skills. This treatment consists of eight online therapy sessions, each lasting 60 to 90 minutes, with the goal of helping participants better understand and manage their emotions.

Although specific side effects for BEST have not been identified, online therapy is generally considered safe and well-tolerated. The trial phase is labeled as "Not Applicable," indicating that safety is a primary focus. Potential risks are still under study, but online therapy typically poses minimal physical risk since it involves talking and emotional exercises, not medication.

For those considering participation, BEST offers a supportive and interactive approach to improving emotional well-being after a brain injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Building Emotional Self-Awareness Teletherapy (BEST) is unique because it delivers therapy directly to patients' homes through telehealth sessions, making it accessible and convenient. Unlike traditional in-person therapy, which can be challenging to attend for those with traumatic brain injury (TBI), this teletherapy focuses specifically on enhancing emotional skills to help manage the emotional and psychological effects of TBI. Researchers are excited about this approach because it offers a personalized and flexible way to support emotional recovery, potentially reaching a wider audience who may have difficulty accessing standard care options like in-person cognitive behavioral therapy or medication management.

What evidence suggests that this teletherapy is effective for traumatic brain injury?

Research suggests that Building Emotional Self-Awareness Teletherapy (BEST), which participants in this trial will receive, might assist individuals with mild traumatic brain injury (mTBI). After a brain injury, people often struggle with emotional awareness, which can hinder recovery. BEST aims to enhance emotional health and resilience by helping individuals understand and manage their emotions better. Although detailed human data remains limited, the concept is that improving emotional awareness can enhance recovery. Early findings indicate that this type of teletherapy might improve emotional skills, which mTBI often affects. ^{1 2 3 4 5}

Who Is on the Research Team?

Flora Hammond, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for U.S. residents over 18 who've had a mild traumatic brain injury at least 6 months ago and struggle with recognizing and regulating emotions. They must speak English, have stable medication for mood if applicable, and be able to use video conferencing tech. Californians, those in other mood-related trials or intensive rehab, with certain neurological or severe psychiatric conditions are excluded.

Inclusion Criteria

It has been over 6 months since my traumatic brain injury.

Elevated alexithymia and emotion dysregulation (defined by >.5 standard deviation above means on the TAS-20 and DERS)

U.S. resident (exclusion for California residents)

Exclusion Criteria

I do not have any impairments that would prevent me from participating.

I do not have an active major psychiatric disorder that could be a safety concern.

My medications affecting mood won't change during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 one-on-one teletherapy training sessions to enhance emotional skills, each lasting approximately 60-90 minutes

6 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Building Emotional Self-Awareness Teletherapy (BEST)

Trial Overview The BEST study tests a remote therapy program designed to help people with mild traumatic brain injuries improve their emotional self-awareness and regulation. It aims to see if the treatment is doable, acceptable to participants, and effective at enhancing resilience and reducing negative moods.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

National Intrepid Center of Excellence

Collaborator

Trials

4

Recruited

250+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05623046

Building Emotional Self-Awareness Teletherapy (BEST) Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms. Detailed Description. This Phase I ...

2. rhirehab.com rhirehab.com/research-training/research/current-studies/brain-injury/building-emotional-self-awareness-teletherapy-a-tool-to-optimize-psychological-health-outcomes-for-persons-with-traumatic-brain-injury/

Building Emotional Self-awareness Teletherapy: A Tool to ... The purpose of the study is to find out if a remotely delivered educational training program about emotions can help people have better emotional health after ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4769700/

Self-awareness and traumatic brain injury outcome - PMC Impaired self-awareness following a traumatic brain injury (TBI) can reduce the effectiveness of rehabilitation, resulting in poorer outcomes.

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05623046?keyword=%22Concussion%22

Building Emotional Self-Awareness Teletherapy (BEST) To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered intervention for civilians and service members with mild ...

5. withpower.com withpower.com/trial/phase-mild-concussion-11-2022-1b60e

BEST Teletherapy for Traumatic Brain Injury (BEST Trial) Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms. Show more. Who Is on the Research Team?