Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-02 @ 2:20 AM
Study NCT ID:
NCT05115656
Status:
UNKNOWN
Last Update Posted:
2023-10-06
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Intervention for Traumatic Brain Injury Wellbeing
Sponsor:
Kessler Foundation
Organization:
Study Overview
Official Title:
The Effectiveness and Underlying Mechanism of a Wellbeing Program for Traumatic Brain Injury - A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 90IFRE0016 | OTHER_GRANT | NIDILRR | View |