Online Intervention for Traumatic Brain Injury Wellbeing

NCT05115656 | Unknown DMC

• 2 other identifiers: R-1037-1890IFRE0016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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

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

• 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

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

• 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

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

• 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

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

• 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.

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

• 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

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

• 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.

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

• 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

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

• 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.

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

• 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.

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

Secondary Outcomes (18)

• Pre to Post Change in Quality of Life after brain injury

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

• Pre to Post Change in Everyday Function

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

• Pre to Post Change in Behavioral Function

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

• Pre to Post Change in Awareness

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

• Pre to Post Change in Community Integration

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

Study Arms (2)

Online group intervention 1

EXPERIMENTAL

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.

Behavioral: Online group 1

Online group intervention 2

ACTIVE COMPARATOR

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.

Behavioral: Online group 2

Interventions

Online group 1 BEHAVIORAL

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 intervention 1

Online group 2 BEHAVIORAL

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 intervention 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

You may not qualify if:

• 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.
• Being pregnant or planning to become pregnant
• Have had a penetrating TBI
• Left handed (to control for hand dominance effect on neuroimaging)

Sponsors & Collaborators

• Kessler Foundation: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Emotional Regulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Self-Control; Social Behavior; Behavior

Study Officials

• Jean Lengenfelder, Ph.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline V Leddy, B.A.

CONTACT

973-324-8429; jleddy@kesslerfoundation.org

Diana Maloku, B.A.

CONTACT

(973) 324-8393; DMaloku@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Rigorous, Double-Masked/Double-Blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director

Model Details: Participants (Moderate to Severe TBI patients) will be randomized into one of 2 online group interventions.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 10, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

US (1)