Clinical trial NCT02922569: Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
Official title: Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: VA Connecticut Healthcare System
First posted: 2016-10-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in performance on global cognitive composite score
timeFrame: At 3 months and at 6 months
Secondary outcomes:
measure: Changes in performance on processing speed composite score
timeFrame: At 3 months and at 6 months
measure: Changes in performance on memory composite score
timeFrame: At 3 months and at 6 months
measure: Changes in performance on executive function composite score
timeFrame: At 3 months and at 6 months
measure: Change in functional performance
timeFrame: At 3 months and at 6 months
measure: Change in TBI functional status
timeFrame: At 3 months and at 6 months
measure: Changes in brain function
timeFrame: At 3 months
measure: Changes in brain structure
timeFrame: At 3 months
measure: Changes in task-related brain activation
timeFrame: At 3 months
Other outcomes:
measure: Change in Neurobehavioral Symptoms
timeFrame: At 3 months and at 6 months
measure: Change in PTSD Symptoms
timeFrame: At 3 months and at 6 months
measure: Change in Depressive Symptoms
timeFrame: At 3 months and at 6 months
measure: Change in Health-Related Quality of Life
timeFrame: At 3 months and at 6 months
measure: Change in Executive Function Symptoms
timeFrame: At 3 months and at 6 months
measure: Change in Cognitive Symptoms
timeFrame: At 3 months and at 6 months
measure: Change in Work/School Status
timeFrame: At 3 months and at 6 months
measure: Change in Physical Activity
timeFrame: At 3 months
measure: Change in Diet
timeFrame: At 3 months
measure: Change in Social Activity
timeFrame: At 3 months
measure: Change in Sleep
timeFrame: At 3 months
measure: Change in Functional Abilities
timeFrame: At 3 months
Locations:
city: West Haven
country: United States
facility: Veterans Affairs Connecticut Health Care System
state: Connecticut
Study officials:
affiliation: Posit Science Corporation
name: Kyu Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: