Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/21/2018 |
| Start Date: | March 31, 2017 |
| End Date: | December 2019 |
| Contact: | Sarah-Jane Kim |
| Email: | sarah-jane.kim@positscience.com |
| Phone: | 415-539-3130 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
