Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI

Not Applicable

Completed

• Conditions: Mild Traumatic Brain Injury
• Interventions: Other: Commercially available computerized training; Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Traumatic Brain Injury Information Session; Other: Mindfulness Training

• Registration Number: NCT02922569
• Lead Sponsor: Posit Science Corporation

Brief Summary

This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Detailed Description

The primary objective of this study is to evaluate the effects of combination of mindfulness training (MT) and adaptive cognitive training (CT) on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with traumatic brain injury (TBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Study Start: 2017-03-31
• Primary Completion: 2020-08-30
• Study Completion: 2020-09-14
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Participants must be 18 years of age or older
• Participants must have diagnosis of mild traumatic brain injury (mTBI) confirmed by Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF)
• Participants must have persistent cognitive dysfunction confirmed by an objective measure (Automated Neuropsychological Assessment Metrics (ANAM) TBI Battery with a score at least one standard deviation below the age-adjusted norm for a military sample) or a subjective measure (Ruff Neurobehavioral Inventory (RNBI) with a score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive)
• Participants must be at least six months out from their most recent traumatic brain injury (TBI), concussion, and/or blast exposure
• Participant must be a fluent English speaker
• Participants must score ≥ 70 on the Wechsler Test of Adult Reading (WTAR)
• Participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse

Exclusion Criteria

• Participants with history of TBI with loss of consciousness for more than 24 hours or post-traumatic amnesia for more than 7 days
• Participants with a history of penetrating head wounds
• Participants who are in-patients
• Participants with a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis)
• Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Participants showing signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
• Participants with clinically significant visual field deficits
• Participants judged to be lacking effort
• Participants with problems performing assessments or comprehending or following spoken instructions
• Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study
• Participant with self-reported claustrophobia or physician-reported implanted devices (e.g. pacemakers, cochlear implants, aneurysm clips, etc.) and pregnant women will not be able to participate in MRI portion of study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	Traumatic Brain Injury Information Session	Commercially available computerized training and traumatic brain injury information session requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session.
Active Comparator	Commercially available computerized training	Commercially available computerized training and traumatic brain injury information session requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session.
Experimental Treatment	Computerized Plasticity-Based Adaptive Cognitive Training	Computerized plasticity-based adaptive cognitive training and mindfulness training requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session.
Experimental Treatment	Mindfulness Training	Computerized plasticity-based adaptive cognitive training and mindfulness training requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session.

Primary Outcome Measures

Name	Time	Method
Changes in performance on global cognitive composite score	At 3 months and at 6 months	Change in performance on global cognitive composite score based on the average of all normalized assessment measures.

Secondary Outcome Measures

Name	Time	Method
Changes in performance on memory composite score	At 3 months and at 6 months	Change in performance on memory will be measured using the composite score created by averaging the z-scores of N-Back task, Spatial Working Memory task, WAIS-IV Digit Span and Rey Auditory Verbal Learning Test (RAVLT).
Change in functional performance	At 3 months and at 6 months	Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.
Changes in brain function	At 3 months	Change in resting state functional connectivity will be measured by 12-minutes of resting state functional MRI. Participants will be instructed to keep their eyes open and maintain attention on a white fixation cross on a black screen.
Changes in brain structure	At 3 months	Structural brain integrity will be measured with a high resolution 3D T1-weighted scan with good gray/white matter contrast and a complementary high-resolution T2-weighted anatomical scan.
Changes in performance on processing speed composite score	At 3 months and at 6 months	Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.
Changes in performance on executive function composite score	At 3 months and at 6 months	Change in performance on executive function will be measured using the composite score created by averaging the z-scores for the Trail Making, Flanker, and Stroop tasks.
Changes in task-related brain activation	At 3 months	Change in functional connectivity and brain activation will be measured while performing N-Back Task.
Change in TBI functional status	At 3 months and at 6 months	Between-group magnitude of change in overall T-score using the self-report measure, Mayo-Portland Adaptability Inventory (MPAI-4). The overall T-score range is -38 to 106. Higher scores indicate more severe TBI functional status.

Trial Locations

Locations (1)

Veterans Affairs Connecticut Health Care System; 🇺🇸 West Haven, Connecticut, United States