Mild Traumatic Brain InjuryCogMindNCT02922569
Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
A study testing Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training and Mindfulness Training in people with Mild Traumatic Brain Injury, run by Posit Science Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training and Mindfulness Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 14 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Connecticut Health Care System
West Haven, Connecticut, 06516
About this study
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.
Read the 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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training, Mindfulness Training, Traumatic Brain Injury Information Session
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Plasticity-Based Adaptive Cognitive TrainingOther
Thirty minutes of training on computerized exercises that targets processing speed, memory and attention.
Commercially available computerized trainingOther
Thirty minutes of training on computerized, casual video games.
Mindfulness TrainingOther
Ten minutes of using an online training course that teaches skills to help overcome ongoing life stressors.
Traumatic Brain Injury Information SessionOther
Ten minutes of viewing traumatic brain injury related news, information, and programs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Commercially available computerized training; Other: Traumatic Brain Injury Information Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months and at 6 months
Secondary outcomes (8)
Changes in performance on processing speed composite score
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.
Measured: At 3 months and at 6 months
Changes in performance on memory composite score
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).
Measured: At 3 months and at 6 months
Changes in performance on executive function composite score
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.
Measured: At 3 months and at 6 months
Change in functional performance
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.
Measured: At 3 months and at 6 months
Change in TBI functional status
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.
Measured: At 3 months and at 6 months
Changes in brain function
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.
Measured: At 3 months
Changes in brain structure
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.
Measured: At 3 months
Changes in task-related brain activation
Change in functional connectivity and brain activation will be measured while performing N-Back Task.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start31 Mar 2017
- Primary completion30 Aug 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Connecticut Healthcare System, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Kyu Lee, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922569
- Sponsor's protocol ID
- PSC-0616-16
- Other IDs
- AZ150059
- Acronym
- CogMind
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2016
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
- ClinicalTrials.gov ID
- NCT02922569
- Acronym / sponsor ID
- CogMind / PSC-0616-16
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- VA Connecticut Healthcare System, Congressionally Directed Medical Research Programs
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-Based Adaptive Cognitive Training, Other: Mindfulness TrainingComputerized 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. |
| Active Comparator | Active comparator | Other: Commercially available computerized training, Other: Traumatic Brain Injury Information SessionCommercially 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive TrainingThirty minutes of training on computerized exercises that targets processing speed, memory and attention. | Other | Experimental Treatment |
| Commercially available computerized trainingThirty minutes of training on computerized, casual video games. | Other | Active Comparator |
| Mindfulness TrainingTen minutes of using an online training course that teaches skills to help overcome ongoing life stressors. | Other | Experimental Treatment |
| Traumatic Brain Injury Information SessionTen minutes of viewing traumatic brain injury related news, information, and programs. | Other | Active Comparator |
Primary outcome
Changes in performance on global cognitive composite score
Time frame: At 3 months and at 6 months
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
8 secondary outcomes
Changes in performance on processing speed composite score
Time frame: At 3 months and at 6 months
Changes in performance on memory composite score
Time frame: At 3 months and at 6 months
Changes in performance on executive function composite score
Time frame: At 3 months and at 6 months
Change in functional performance
Time frame: At 3 months and at 6 months
Change in TBI functional status
Time frame: At 3 months and at 6 months
Changes in brain function
Time frame: At 3 months
Changes in brain structure
Time frame: At 3 months
Changes in task-related brain activation
Time frame: At 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu Lee, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training and Mindfulness Training in people with Mild Traumatic Brain Injury, run by Posit Science Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in performance on global cognitive composite score (time frame: At 3 months and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.