Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI (CogMind)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02922569|
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : June 19, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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 ]
- 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 ]
- 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 ]
- 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 ]
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
|Contact: Sarah-Jane Kimemail@example.com|
|United States, Connecticut|
|Veterans Affairs Connecticut Health Care System||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Sarah-Jane Kim firstname.lastname@example.org|