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Traumatic Brain InjuryNCT05115656

Online Intervention for Traumatic Brain Injury Wellbeing

A study testing Online group 1 and Online group 2 in people with Traumatic Brain Injury and Attention Impaired, run by Kessler Foundation at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Online group 1 and Online group 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Jun 2021to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 25Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Jacqueline V Leddy, B.A. contact

973-324-8429

jleddy@kesslerfoundation.org

Diana Maloku, B.A. contact

(973) 324-8393

DMaloku@kesslerfoundation.org

United States1 site, 1 recruiting

  • Kessler Foundation

    East Hanover, New Jersey, 07936

    Jacqueline Leddy, B.A., 973-324-8429, JLeddy@kesslerfoundation.org

    Diana Maloku, B.A., 9733248443, DMaloku@kesslerfoundation.org

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Online group 1, Online group 2
Keywords
Intervention, Psychological, Emotional, Well-being, Memory, Attention, Problem-Solving
Medical subject headings
Brain Injuries, Traumatic, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online group 1Behavioural

    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 2Behavioural

    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.

Study groups in NCT05115656
Study groupRoleWhat they receive
Online group intervention 1ExperimentalParticipants 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.
Receives: Behavioral: Online group 1
Online group intervention 2Active comparatorSimilar 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.
Receives: Behavioral: Online group 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre to Post Change in Sustained attention (Response time variability)

    Response time variability of the sustained attention to response task (SART) will provide measure of improvement in sustained attention

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  2. Pre to Post Change in Sustained attention (commission errors)

    Commission errors of the sustained attention to response task (SART) will provide measure of improvement in sustained attention

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  3. Pre to Post Change in Present Moment Awareness

    Improvement in the ability to attend to the present moment will be measured using the Five Facet Mindfulness Questionnaire (FFMQ). Total score from 1 to 5, higher score representing greater mindfulness

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  4. Pre to Post Change in Mindfulness/Present Moment Awareness

    Improvement in mindfulness will be measured using the Freiburg Mindfulness Inventory (FMI) Questionnaire. Score ranges between 14 and 56 with higher scores indicating higher mindfulness

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  5. Pre to Post Change in Behavioral Measures of Attention

    Attention [lapses] will be assessed using the Attention-Related Cognitive Errors Scale (ARCES), as it will provide a measure for the frequency of cognitive failure experiences (i.e. getting distracted, reading without paying attention to content, losing track of a conversation, etc.). Score ranges from 1 to 5 with higher scores indicating greater attention lapses.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  6. Pre to Post Change in Self-Efficacy

    Self efficacy will be measured using the Self Efficacy Questionnaire for Symptom Management Scale. Score ranges from 13-130 with higher score indicating greater self-efficacy

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  7. Pre to Post Change in Depression

    Depression will be measured using the PHQ-8. Score ranges from 0-24 with higher score indicating greater depression.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  8. Pre to Post Change in anxiety

    This will be measured using the Spielberger's State Anxiety Inventory (STAI). Score ranges from 20-80, with higher score indicating greater anxiety

    Measured: Baseline (1st day); at 10 weeks; following 6 months

  9. Pre to Post Change in emotional regulation

    This will be measured using the Difficulty in Emotional Regulation Scale (DERS). Total score ranges from 36-180, with higher score indicating greater problems with emotional regulation.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  10. Pre to Post Change in socio-emotional problem solving

    This will be measured using the Social Problem-Solving Inventory - Revised (SPSI-R). Total score ranges from 0-100, with higher score indicating greater social problem-solving ability.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

Secondary outcomes (18)

  1. Pre to Post Change in Quality of Life after brain injury

    This will be measured using Quality of Life After Brain Injury (QOLIBRI).Total score ranges from 0-100, with higher score indicating greater health related quality of life after TBI.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  2. Pre to Post Change in Everyday Function

    This will be measured using SF12. Total score ranges from 0-100, with higher score indicating greater physical and mental health functioning.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  3. Pre to Post Change in Behavioral Function

    This will be measured using Functional Behavior Profile. Total score ranges from 0-108, with higher score indicating greater behavioral function.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  4. Pre to Post Change in Awareness

    This will be measured using Awareness Questionnaire (AQ).Total score ranges from 17-85 with higher score indicating greater function after TBI. Difference scores ( family subtracted from patient ratings) range from -68 to 68, with greater/lower score than 0 associated with greater impaired awareness (rating his function greater/lower than family).

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  5. Pre to Post Change in Community Integration

    This will be measured using the Community Integration Questionnaire (CIQ). Score ranges from 0 to 29, with higher scores indicating greater independence and community integration.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  6. Pre to Post Change in Socio-emotional behavior executive functioning skills

    This will be measured using the Brock Adaptive Functioning Questionnaire. Score ranges from 20 to 100, with lower scores indicating better functioning.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  7. Pre to Post Change in Satisfaction With Life

    This will be measured using Satisfaction With Life Scale (SWLS). Score ranges from 5-35 with higher score indicating greater life satisfaction.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  8. Pre to Post Change in Emotional Regulation

    This will be measured using the Emotional Regulation Questionnaire (ERQ). Items averaged score ranges from 1-7 with higher score indicating greater emotional regulation.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  9. Pre to Post Change in Basic Empathy

    This will be measured using the Basic Empathy Scale (BES). Items averaged score ranges from 1-5 with higher score indicating greater empathy.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  10. Pre to Post Change in Empathy Quotient

    This will be measured using the Empathy Quotient (EQ). Score ranges from 0-80 with higher score indicating greater empathy.

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  11. Pre to Post Change in Neuropsychological Measures - Intelligence

    This will be measured using the Wechsler abbreviated scale of intelligence manual (WASI)

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  12. Pre to Post Change in Neuropsychological Measures - Verbal learning and memory

    This will be measured using the California Verbal Learning Test (CVLT-II)

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  13. Pre to Post Change in Neuropsychological Measures - Processing speed

    This will be measured using the Oral Symbol Digit Modalities Test (SDMT)

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  14. Pre to Post Change in Neuropsychological Measures - Alertness and Vigilance

    This will be measured using the Digit Vigilance Test

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  15. Pre to Post Change in Neuropsychological Measures - Attention/executive function

    This will be measured using the Paced Auditory Serial Addition Test

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  16. Pre to Post Change in Neuropsychological Measures - Executive function in cognitive set shifting and inhibition

    This will be measured using the Delis-Kaplan Executive Function System (D-KEFS ) Stroop

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  17. Pre to Post Change in Neuropsychological Measures - Executive function in sequential set-shifting

    This will be measured using the Oral Trail Making Test

    Measured: Change from pre (baseline) to post (10 weeks) intervention

  18. Pre to Post Change in Neuropsychological Measures in Executive function - Verbal Fluency

    This will be measured using the Delis-Kaplan Executive Function System (D-KEFS ) Verbal Fluency

    Measured: Change from pre (baseline) to post (10 weeks) intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start1 Jun 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Participants (Moderate to Severe TBI patients) will be randomized into one of 2 online group interventions.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05115656
Sponsor's protocol ID
R-1037-18
Other IDs
90IFRE0016
Status last verified
Oct 2023
First submitted
20 Oct 2021
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Online group 1 and Online group 2 in people with Traumatic Brain Injury and Attention Impaired, run by Kessler Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacqueline V Leddy, B.A. (973-324-8429, jleddy@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre to Post Change in Sustained attention (Response time variability) (time frame: Change from pre (baseline) to post (10 weeks) intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05115656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.

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