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

Posit Science

Status: Completed

Conditions: Mild Traumatic Brain Injury

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

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02922569

PSC-0616-16

AZ150059 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups

Experimental Treatment

Experimental group

Description:

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.

Treatment:

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Other: Mindfulness Training

Active Comparator

Active Comparator group

Description:

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.

Treatment:

Other: Commercially available computerized training

Other: Traumatic Brain Injury Information Session