Online intervention to improve wellbeing in traumatic brain injury patients

The Effectiveness and Underlying Mechanism of a Wellbeing Program for Traumatic Brain Injury - A Randomized Clinical Trial

This study is testing an online program that uses mindfulness techniques to help people with traumatic brain injury improve their emotional control and daily functioning.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Kessler Foundation (Academic / other)
• Locations: 1 site (East Hanover, New Jersey)
• Trial ID: NCT05115656 on ClinicalTrials.gov

What this trial studies

This project evaluates the effectiveness of an online therapeutic intervention designed for patients with traumatic brain injury (TBI) to enhance their emotional regulation and attention. The intervention utilizes modified mindfulness-based stress reduction (MBSR) techniques to address cognitive and behavioral deficits commonly experienced by TBI patients. By employing a rigorous randomized controlled trial methodology, the study aims to assess the intervention's impact on self-regulation and everyday functioning. The results will provide insights into the functional and structural neural effects of the intervention, ultimately refining therapeutic approaches for TBI patients.

Who should consider this trial

Good fit: Ideal candidates include individuals with a confirmed diagnosis of moderate to severe TBI who are at least 12 months post-injury and exhibit attention deficits.

Not a fit: Patients with mild TBI or those who do not demonstrate attention deficits may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly improve emotional regulation and daily functioning for patients with traumatic brain injury.

How similar studies have performed: Other studies have shown promise in using mindfulness-based interventions for cognitive and emotional improvements, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Confirmed diagnosis of moderate to severe TBI through medical records or interview, based on the Glasgow Coma Scale (GCS) and the definition adopted by the TBI Model Systems National Database (TBIMS NDB), where one of the following criteria must be met:

   * Post traumatic amnesia \> 24 hours
   * Trauma related intracranial neuroimaging abnormalities
   * Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication)
   * GCS in the emergency department of less than 13 (unless due to intubation, sedation, or intoxication);
2. At least 12 months post injury
3. Presence of a deficit in sustained attention as measured by the Attention-Related Cognitive Errors Scale (ARCES) \[69\] score greater than 3.5 or presence of a deficit in sustained attention as measured by the sustained attention to response task (SART) \[64\]. Impairment will be defined as having omissions or the reaction time variability scores, two measures of "inattentiveness," one standard deviation above the normative mean.
4. Willingness and ability to participate in all testing and the 10-week intervention and daily home activities/exercises.
5. Medically stable and no plan for major change in medications for at least 6 months or for the duration of the study
6. Have sufficient language functioning to participate in an intervention conducted in English
7. Average memory functioning to be able to benefit from a progression of treatment (as measured by total learning trials on the California Verbal Learning Test-II within 2 standard deviations of the mean)

General Exclusion Criteria:

1. Severe cognitive impairment as defined by a Mini-Mental State Examination score \< 18.
2. Any previous neurological injury or illness in addition to the documented TBI (e.g. epilepsy, MS).
3. Active substance abuse
4. Acquired brain injury of nontraumatic origin
5. Be enrolled or currently enrolled in another research study that is likely to affect participation in this research study
6. Significant psychiatric history (e.g. schizophrenia, bipolar disorder) due to the potential influence of such disorders on cognitive functioning (because of the prevalence of depression/anxiety in the TBI population, subjects will not be excluded based on a history of depression/anxiety; rather, these will be controlled by including measures of depression/anxiety as covariates in group-level analyses)
7. Had previously participated in regular mindfulness based activities such as meditation and yoga.

MRI-Specific Exclusion Criteria:

1. Being pregnant or planning to become pregnant
2. Have had a penetrating TBI
3. Left handed (to control for hand dominance effect on neuroimaging)
4. Focal injury if the injury necessitated neurosurgical intervention and/or caused gross derangement of neuroanatomy (Given that TBI is most often represented by mixed pathophysiology and diffuse axonal injury is nearly universal findings, focal injury will not be a systematic exclusionary criteria).
5. For all study participants, additional exclusionary criteria associated with MRI will be discussed and enforced. This includes, conditions contraindicated for MRI (implanted metallic devices-aneurysm clips, pacemakers, claustrophobia for subject safety), surgical hardware in the head or cervical spine will also be excluded due to potential for severe image artifacts. We will be using the RONIC MRI screening form for this purpose.

Where this trial is running

East Hanover, New Jersey

• Kessler Foundation — East Hanover, New Jersey, United States (Recruiting)

Study contacts

• Principal investigator: Jean Lengenfelder, Ph.D. — Kessler Foundation
• Study coordinator: Jacqueline V Leddy, B.A.

Conditions Traumatic Brain Injury; Attention Impaired; Emotional Regulation; Intervention; Psychological; Emotional; Well-being; Memory