RECRUITING

Online Intervention for Traumatic Brain Injury Wellbeing

Conditions

Traumatic Brain Injury Attention Impaired Emotional Regulation Intervention Psychological Emotional Well-being Memory Attention Problem-Solving

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-01

Study Completion:2023-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05115656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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.

Inclusion Criteria

Exclusion 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)

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.

Contacts and Locations

Study Contact

Jacqueline V Leddy, B.A.

CONTACT

973-324-8429

jleddy@kesslerfoundation.org

Diana Maloku, B.A.

CONTACT

(973) 324-8393

DMaloku@kesslerfoundation.org

Principal Investigator

Jean Lengenfelder, Ph.D.

PRINCIPAL_INVESTIGATOR

Kessler Foundation

Study Locations (Sites)

Kessler Foundation

East Hanover, New Jersey, 07936

United States

Collaborators and Investigators

Sponsor: Kessler Foundation

Jean Lengenfelder, Ph.D., PRINCIPAL_INVESTIGATOR, Kessler Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01

Study Completion Date2023-12

Study Record Updates

Study Start Date2021-06-01

Study Completion Date2023-12

Terms related to this study

Keywords Provided by Researchers

Intervention
Psychological
Emotional
Well-being
Memory
Attention
Problem-Solving

Additional Relevant MeSH Terms

Traumatic Brain Injury
Attention Impaired
Emotional Regulation