Online Intervention for Traumatic Brain Injury Wellbeing

Status unconfirmed · Not applicable

Conditions studied: Traumatic Brain Injury, Attention Impaired, Emotional Regulation

In brief

Traumatic brain injury (TBI) patients face notable impairments which lead to reduced performance and regulation of daily and overall functioning. There are a number of interventions made to combat these qualms; however, such interventions have historically been therapeutically demanding, which limits their practical benefit. An online therapeutic intervention can provide a cost-effective approach that can be particularly well-suited to the needs and limitations of TBI. It focuses both on developing awareness and attention, which are often impaired, and are critical to improving emotional and behavioral regulation and everyday function. This project is aimed at assessing the effectiveness and underlying mechanism of modified mindfulness based stress reduction (MBSR) using a rigorous randomized controlled trial. Poised to provide a rigorous approach to efficacy development and analysis, Results of the study will provide valuable information that will ultimately support the refinement of an intervention that can have a real impact on patients' ability to resume a fully functional and satisfying life, and the design of an adequate therapeutic intervention for TBI patients.

Key facts

Study ID: NCT05115656
Run by: Kessler Foundation
People needed: 60
Starts: 2021-06-01
Expected to finish: 2023-12-01
Last updated by the study team: 2023-10-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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);
At least 12 months post injury
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.
Willingness and ability to participate in all testing and the 10-week intervention and daily home activities/exercises.
Medically stable and no plan for major change in medications for at least 6 months or for the duration of the study
Have sufficient language functioning to participate in an intervention conducted in English
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:
Severe cognitive impairment as defined by a Mini-Mental State Examination score < 18.
Any previous neurological injury or illness in addition to the documented TBI (e.g. epilepsy, MS).
Active substance abuse
Acquired brain injury of nontraumatic origin
Be enrolled or currently enrolled in another research study that is likely to affect participation in this research study
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)
Had previously participated in regular mindfulness based activities such as meditation and yoga.
MRI-Specific Exclusion Criteria:
Being pregnant or planning to become pregnant
Have had a penetrating TBI
Left handed (to control for hand dominance effect on neuroimaging)
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).
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 it is running

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

Full record on ClinicalTrials.gov

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