Telehealth Rehabilitation for Traumatic Brain Injury

(GOALS TH Trial)

Overseen By Tatjana Novakovic-Agopian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Psychotropic medications

Disqualifiers: Severe memory problems, Substance abuse, others

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

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific kind of telehealth training can help veterans with past traumatic brain injuries (TBI) improve their everyday lives. The study will test a goal-oriented telehealth rehabilitation program designed to boost attention and self-regulation through activities meaningful to the participants. Veterans who experienced a mild to moderate TBI over six months ago and find cognitive issues disrupting their daily life might be a good fit. Participants will engage in group and individual telehealth sessions, along with home practice. The trial will compare this program to an educational telehealth program to evaluate which works better. As an unphased trial, this study offers veterans the opportunity to explore innovative telehealth solutions tailored to their needs.

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

The trial does not specify if you need to stop taking your current medications, but it does exclude those with active changes in psychotropic medications (drugs affecting mood, perception, or behavior). It's best to discuss your specific medications with the trial team.

What prior data suggests that this telehealth rehabilitation method is safe for Veterans with TBI?

Research has shown that telehealth rehabilitation focused on enhancing planning and decision-making skills is generally well-received by participants. Studies have found that this training can help individuals with long-term brain injuries improve their ability to set and achieve goals. No specific reports of negative effects have emerged from this treatment, suggesting it is safe. The training includes both group and individual sessions conducted online, providing convenience for participants. While researchers continue to study this treatment, previous use has demonstrated positive results without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores telehealth rehabilitation for traumatic brain injury (TBI), focusing on executive functioning. Traditional TBI treatments often rely on in-person therapy and medications. However, the Goal-Oriented Attentional Self-regulation (GOALS TH) training offers a unique approach by utilizing telehealth to deliver structured group and individual sessions, making rehabilitation more accessible and flexible. The EDU TH training serves as an active control, ensuring that the effectiveness of GOALS TH can be accurately measured. This trial could pave the way for more accessible and effective rehabilitation methods for TBI patients, especially those with limited access to in-person care.

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

This trial will compare two telehealth rehabilitation approaches for veterans with traumatic brain injury (TBI). Research has shown that focusing on specific goals can improve thinking skills in veterans with long-term TBI. Participants in this trial may receive Goal-Oriented Attentional Self-regulation (GOALS TH) training, which uses goal-focused attention techniques to enhance mental performance. Studies suggest that this method helps veterans concentrate on meaningful activities, leading to better outcomes in daily life. Alternatively, participants may receive EDU TH training, an active control matched for therapist time and homework load. Overall, these approaches hold promise for addressing thinking challenges related to TBI. ^{1 6 7 8 9}

Who Is on the Research Team?

Tatjana Novakovic-Agopian, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with a history of chronic traumatic brain injury (TBI) who are facing cognitive and emotional challenges. It aims to help them reintegrate into the community by improving their attentional control through goal-directed activities.

Inclusion Criteria

I had a mild to moderate brain injury more than 6 months ago.

Veteran

At least 12th grade education or equivalent

Exclusion Criteria

Amnesic/Severe memory problems

Active Substance Abuse/Dependence

Medical condition that may affect mental status/disrupt study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo video telehealth cognitive rehabilitation training, including group-based and individual sessions, with home practice

10 weeks

10 group sessions (telehealth), 3 individual sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Goal-oriented Telehealth Rehabilitation of Executive Functioning

Trial Overview The study tests two telehealth interventions: GOALS TH, which focuses on training attentional control via relevant activities, and EDU TH, an educational approach. The effectiveness in enhancing community integration will be compared.

How Is the Trial Designed?

Group I: GOALS TH Experimental Treatment 1 Intervention

The Goal-Oriented Attentional Self-regulation training involves ten 2-hour sessions of group-based telehealth training, three individual 1-hour telehealth training sessions, and approximately 20 hours of home practice. It is conducted in a small group format.

Group II: EDU TH Active Control 1 Intervention

The EDU TH training is an active control training matched with GOALS TH for therapist time, homework load, and participation in a group. It involves ten 2-hour telehealth sessions of group-based training, three individual 1-hour telehealth training sessions, and approximately 20 hours of home practice.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07190365

Goal-oriented Telehealth Rehabilitation of Executive ... This study aims to increase access and availability of evidence-based, in-person administered cognitive rehabilitation training for Veterans ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8104023/

Training in Goal-Oriented Attention Self-Regulation ... Training in attentional self-regulation applied to participant-defined goals may improve cognitive functioning in veterans with chronic TBI.

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04111549

GOALS Cognitive Training Delivered to Aging Veterans in ... This study will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home.

4. tandfonline.com tandfonline.com/doi/abs/10.3109/02699052.2013.766927

Telerehabilitation for addressing executive dysfunction ... Conclusions: Telerehabilitation shows promise as a way to deliver the CO-OP approach and may help promote community integration of individuals living with TBI.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1089/neu.2019.6806

Goal-Oriented Attention Self-Regulation Training Improves ... Training in attentional self-regulation applied to participant-defined goals may improve cognitive functioning in Veterans with comorbid PTSD and mTBI.

6. withpower.com withpower.com/trial/phase-mild-to-moderate-traumatic-brain-injury-2026-8359b

Telehealth Rehabilitation for Traumatic Brain Injury · Info ... It aims to help them reintegrate into the community by improving their attentional control through goal-directed activities. Inclusion Criteria.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5318616/

Long-Term Use and Perceived Benefits of Goal-Oriented ... These results provide preliminary evidence that GOALS training may help improve goal-directed functioning for individuals in the chronic phase of brain injury.

8. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-01061324&doi=10.1002/central/CN-01061324&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Goal-oriented executive function training in veterans with ... Goal-oriented executive function training in veterans with chronic TBI: short and longer term outcomes. Novakovic‐Agopian T, Abrams G, Chen A, Murphy M ...

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1608645/full

A comprehensive review of rehabilitation approaches for ... This comprehensive review critically examines key rehabilitation strategies for TBI, including neuropsychological assessments, cognitive and neuroplasticity- ...