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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+