Clinical trial NCT05115656: Online Intervention for Traumatic Brain Injury Wellbeing
Official title: The Effectiveness and Underlying Mechanism of a Wellbeing Program for Traumatic Brain Injury - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Attention Impaired
Emotional Regulation
Keywords: Intervention
Psychological
Emotional
Well-being
Memory
Attention
Problem-Solving
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2021-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants (Moderate to Severe TBI patients) will be randomized into one of 2 online group interventions.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: TBI patients suffer from a host of cognitive and behavioral deficits that requires a comprehensive therapeutic approach to be effective at improving self-regulation and everyday function. These deficits can affect a number of critical aspects of individual performance such as awareness, emotional regulation, and self-efficacy. As an alchemy, these serve to be instrumental to TBI patients' emotional regulation capability, and serve as complements to overall satisfactory executive functioning. Efforts have been made in therapeutics to supersede barriers to improving these factors in the form of interventions. Those observed in history had required considerable resources, evident in the apparent high cognitive load and by limits to their effective implementation, wide dissemination and, ultimately, their potential benefit to TBI patients. At present, it is fundamental to explore the benefits of an intervention promising a favorable effect on both attention and present moment awareness (Aim 1), effectiveness in developing emotional regulation and everyday life function (Aim 2), and structured to permit investigation of the functional and structural neural effects on attention (Aim 3). This hypothesis aims to prove these attributes are central to the development of adaptive self-monitoring and self-regulation skills that can be used in a real life environment. The study results will provide valuable information that will ultimately support the refinement of an effective intervention that can have a real impact on patients' ability to improve quality of life, community integration, and supporting an active lifestyle. In addition, acquired neuroimaging will aid in analyzing the effect of the intervention on brain function which will allow for a more established comprehension of the underlying mechanisms driving the benefits, permitting improved design of an effective therapeutic intervention for TBI patients.

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.

Primary outcomes:
measure: Pre to Post Change in Sustained attention (Response time variability)
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Sustained attention (commission errors)
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Present Moment Awareness
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Mindfulness/Present Moment Awareness
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Behavioral Measures of Attention
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Self-Efficacy
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Depression
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in anxiety
timeFrame: Baseline (1st day); at 10 weeks; following 6 months
measure: Pre to Post Change in emotional regulation
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in socio-emotional problem solving
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
Secondary outcomes:
measure: Pre to Post Change in Quality of Life after brain injury
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Everyday Function
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Behavioral Function
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Awareness
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Community Integration
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Socio-emotional behavior executive functioning skills
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Satisfaction With Life
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Emotional Regulation
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Basic Empathy
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Empathy Quotient
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Neuropsychological Measures - Intelligence
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Neuropsychological Measures - Verbal learning and memory
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Neuropsychological Measures - Processing speed
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Neuropsychological Measures - Alertness and Vigilance
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Neuropsychological Measures - Attention/executive function
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Neuropsychological Measures - Executive function in cognitive set shifting and inhibition
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Neuropsychological Measures - Executive function in sequential set-shifting
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
measure: Pre to Post Change in Neuropsychological Measures in Executive function - Verbal Fluency
timeFrame: Change from pre (baseline) to post (10 weeks) intervention
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Jean Lengenfelder, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: