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

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ClinicalTrials.gov Identifier: NCT02922569
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
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. 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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Commercially available computerized training Other: Mindfulness Training Other: Veterans Affairs Information Session Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Experimental Treatment
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
Thirty minutes of training on computerized exercises that targets processing speed, memory and attention.

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

Active Comparator: Active Comparator
Commercially available computerized training and Veterans Affairs 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
Thirty minutes of training on computerized, casual video games.

Other: Veterans Affairs Information Session
Ten minutes of viewing Veterans Affairs related news, information, services, benefits and programs.




Primary Outcome Measures :
  1. Between-group magnitude of change in processing speed utilizing Pattern-Number Comparison and Digit Symbol Coding. [ Time Frame: At 3 months and at 6 months ]
  2. Between-group magnitude of change in memory utilizing WAIS-IV Digit Span and Rey Auditory Verbal Learning Test (RAVLT). [ Time Frame: At 3 months and at 6 months ]
  3. Between-group magnitude of change in executive function utilizing Trail Making Task, Flanker Task and Stroop Task. [ Time Frame: At 3 months and at 6 months ]
  4. Between-group magnitude of change in functional status utilizing Timed Instrumental Activities of Daily Living (TIADL) [ Time Frame: at 3 months and at 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (as recommended by the International Classification of Diseases (ICD-10) definition for post-concussion syndrome) or a subjective measure (as recommended by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) definition of post-concussional disorder)
  • 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)

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 ideations 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922569


Contacts
Contact: Sarah-Jane Kim 415-539-3130 sarah-jane.kim@positscience.com

Locations
United States, Connecticut
Veterans Affairs Connecticut Health Care System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Sarah-Jane Kim       sarah-jane.kim@positscience.com   
Sponsors and Collaborators
Posit Science Corporation
VA Connecticut Healthcare System

Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT02922569     History of Changes
Other Study ID Numbers: PSC-0616-16
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating