Recruiting

Traumatic Brain Injury

Sponsor:

Kessler Foundation

Code:

NCT05115656

Conditions

Traumatic Brain Injury

Attention Impaired

Emotional Regulation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Online group 1

Online group 2

Study Details

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.

Conditions

Traumatic Brain Injury

Attention Impaired

Emotional Regulation

Study ID

NCT05115656

Start date

Jun 1, 2021

Status verified date

Oct, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Online group intervention 1

Participants in group 1 meet weekly online for a 2-hour group sessions for 10 weeks where the instructor will provide leadership in discussions, which will include practice of basic routines. Participants will also be asked to do 20-30 minutes of daily activities/exercises, where they will be asked to practice mental exercises.

active comparator: Online group intervention 2

Similar to group 1, participants will meet weekly online or in person for 2-hour group sessions for 10 weeks where the instructor will provide leadership in discussions, which will include practice of basic routines. Participants will also be asked to do 20-30 minutes of daily activities/exercises, where they will be asked to practice mental exercises.

Interventions

Online group 1

The intervention is specifically tailored to meet particular cognitive standard and satisfy the needs of brain injury patients. For 2-3 hours weekly, participants will be immersed in mental exercises designed to help them overcome various challenges.

Online group 2

The intervention is specifically tailored to meet particular cognitive standard and satisfy the needs of brain injury patients. For 2-3 hours weekly, participants will be immersed in mental exercises designed to help them overcome various challenges.

Primary outcome measure

  • Pre to Post Change in Sustained attention (Response time variability) [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]
  • Pre to Post Change in Sustained attention (commission errors) [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]
  • Pre to Post Change in Present Moment Awareness [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]
  • Pre to Post Change in Mindfulness/Present Moment Awareness [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]
  • Pre to Post Change in Behavioral Measures of Attention [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]
  • Pre to Post Change in Self-Efficacy [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]
  • Pre to Post Change in Depression [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]
  • Pre to Post Change in anxiety [ Time Frame: Baseline (1st day); at 10 weeks; following 6 months ]
  • Pre to Post Change in emotional regulation [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]
  • Pre to Post Change in socio-emotional problem solving [ Time Frame: Change from pre (baseline) to post (10 weeks) intervention ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Principal Investigator:

Didier Allexandre, Ph.D.

More Information

Sponsor

Kessler Foundation

Last update posted

Oct 6, 2023

Last verified

Oct, 2023

Keywords

  • Intervention
  • Psychological
  • Emotional
  • Well-being
  • Memory
  • Attention
  • Problem-Solving

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2023-10-06.