300 Participants NeededMy employer runs this trial

Teletherapy Programs for Concussion

Recruiting at 2 trial locations
GW
Overseen ByGrace Wells
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two teletherapy programs to determine which one more effectively improves emotional health for individuals with a concussion or mild traumatic brain injury (mTBI). Participants will engage in remote brain training sessions designed to enhance emotional awareness or improve overall well-being and quality of life. The study includes four assessments and eight training sessions over approximately eight months, all conducted via a secure video conferencing platform. Individuals who have had a mild TBI for at least six months and experience difficulty identifying or managing emotions might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance emotional health strategies for others in the future.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants should not have unstable medications or anticipate medication changes that affect mood during the study.

What prior data suggests that these teletherapy programs are safe for individuals with a concussion or mild TBI?

Research has shown that teletherapy programs for concussions, like those in this trial, are generally safe. Studies on similar programs have not identified any major safety concerns. For example, one study on tele-rehabilitation for mild traumatic brain injury (mTBI) found it aided recovery without causing significant side effects. Another study on telehealth programs demonstrated they could provide effective care without serious safety issues.

One study examined possible side effects in tele-rehabilitation and found that some participants experienced temporarily worsened symptoms, which improved within 24 hours. This suggests that while some side effects might occur, they usually don't last long or cause serious problems.

Overall, evidence suggests that these teletherapy programs are safe and well-tolerated by participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Teletherapy Programs for Concussion because they offer innovative approaches to managing emotional and cognitive challenges after a concussion. Unlike traditional therapies that might focus only on physical recovery, Program 1 enhances emotional awareness by helping participants recognize and accurately label their emotions, enabling better emotional regulation. Program 2 goes beyond emotional awareness by promoting overall wellbeing and quality of life through a self-management approach grounded in the Health Belief Model. These programs are distinct because they empower individuals to actively engage in their recovery and improve their emotional and cognitive health in a comprehensive manner.

What evidence suggests that this trial's programs could be effective for improving emotional health in people with a concussion or mild TBI?

Research has shown that telehealth can benefit people with concussions. Studies have found that remote therapy programs improve emotional understanding and management in individuals with mild traumatic brain injuries (mTBI). In this trial, participants will join one of two programs. Program 1 helps participants better recognize and express their emotions, aiding recovery. Program 2 aims to enhance overall well-being and quality of life by teaching self-management skills and building confidence. Telehealth has enhanced confidence and recovery in TBI survivors, making these programs promising options for those seeking remote support.12346

Who Is on the Research Team?

DN

Dawn Neumann, PhD, FACRM

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for adults (18+) who had a mild traumatic brain injury or concussion at least 6 months ago, speak English, have trouble identifying and managing emotions, can use video calls on their own device, and are able to give consent. People with unstable medications, other major neurological or psychiatric issues, recent therapy changes, or severe sensory/cognitive problems can't join.

Inclusion Criteria

Mild TBI
Speaks and understands English
Personal device capable of video conferencing and internet
See 4 more

Exclusion Criteria

I have not recently started or changed medications that affect my mood.
Premorbid neurological disorder other than TBI
Active or uncontrolled major psychiatric disorder
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 sessions of 1-on-1 brain training via a secure video-conferencing platform

1 month
8 sessions (virtual)

Assessment

Assessment visits include surveys and questionnaires about participant's emotional health

8 months
4 visits (virtual)

Follow-up

Participants are monitored for psychological health improvements at 3 and 6 months post-treatment

6 months
2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Program 1
  • Program 2

Trial Overview

The study compares two remote brain training programs delivered via secure video calls to see which better improves emotional health in people with past mild brain injuries. Participants complete assessments before and after the program as well as follow-ups up to six months later.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Program 1Experimental Treatment1 Intervention
Group II: Program 2Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials
141
Recruited
42,900+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

Challenges and effectiveness of remote neurological follow ...

This study demonstrates the potential effectiveness of telemedicine in monitoring children with concussions, especially in regions with diverse socioeconomic ...

Clinical Trial Comparing the Efficacy of Two Teletherapy ...

The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) ...

Implementation and Adoption of Tele-Rehabilitation for ... - PMC

Multimodal physical therapy for mild traumatic brain injury (mTBI) has been shown to improve recovery. Due to the COVID-19 pandemic, ...

Feasibility and preliminary efficacy of telehealth ...

Telehealth-delivered interdisciplinary concussion care may improve equity of access; however, the feasibility and efficacy of this approach are unknown.

Effectiveness of telehealth interventions among traumatic ...

The efficacy of telehealth in improving self-efficacy among TBI survivors may be due to multiple factors, such as content and evaluation of the ...

program-development-interdisciplinary-telerehabilitation- ...

The top three barriers included difficulty scheduling appointments, delays or cancellations in treatment, and lack of availability in in the Department of ...