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

NCT02922569 | Completed

• 2 other identifiers: PSC-0616-16AZ150059
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Changes in performance on global cognitive composite score

  Change in performance on global cognitive composite score based on the average of all normalized assessment measures.

  At 3 months and at 6 months

Secondary Outcomes (8)

• Changes in performance on processing speed composite score

  At 3 months and at 6 months

• Changes in performance on memory composite score

  At 3 months and at 6 months

• Changes in performance on executive function composite score

  At 3 months and at 6 months

• Change in functional performance

  At 3 months and at 6 months

• Change in TBI functional status

  At 3 months and at 6 months

Other Outcomes (12)

• Change in Neurobehavioral Symptoms

  At 3 months and at 6 months

• Change in PTSD Symptoms

  At 3 months and at 6 months

• Change in Depressive Symptoms

  At 3 months and at 6 months

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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.

Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Mindfulness Training

Active Comparator

ACTIVE COMPARATOR

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.

Other: Commercially available computerized training; Other: Traumatic Brain Injury Information Session

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training OTHER

Thirty minutes of training on computerized exercises that targets processing speed, memory and attention.

Experimental Treatment

Commercially available computerized training OTHER

Thirty minutes of training on computerized, casual video games.

Active Comparator

Mindfulness Training OTHER

Ten minutes of using an online training course that teaches skills to help overcome ongoing life stressors.

Experimental Treatment

Traumatic Brain Injury Information Session OTHER

Ten minutes of viewing traumatic brain injury related news, information, and programs.

Active Comparator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs: collaborator
• Posit Science Corporation: lead
• VA Connecticut Healthcare System: collaborator

Study Sites (1)

Veterans Affairs Connecticut Health Care System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Kyu Lee, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 4, 2016
• Study Start: March 31, 2017
• Primary Completion: August 30, 2020
• Study Completion: September 14, 2020
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)