Mild Cognitive Impairment, Traumatic Brain Injury
Conditions
Keywords
Processing Speed, Cognition, Intervention, Traumatic Brain Injury, Mild Cognitive Impairment
Brief summary
The purpose of this research study is to investigate the effectiveness of a technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how well this technique can help people with TBI increase their processing speed and their ability to function better in everyday life.
Detailed description
The current proposal is designed to apply this treatment protocol to a large sample of individuals with moderate to severe TBI with documented impairment in PS. The goals of the trial are to (a) test the efficacy of this treatment protocol within a TBI population, (b) evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating longer-term treatment effects. Individuals with moderate to severe TBI, with documented impairment in PS, will be randomly assigned to a treatment group or a control group. Both groups will undergo baseline, immediate post-treatment and long-term follow-up assessment consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to assess the efficacy of SPT in persons with TBI and evaluate its impact on everyday life.
Interventions
BEHAVIORALSpeed of Processing Training
BEHAVIORALPlacebo Control
Sponsors
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of Traumatic Brain Injury or Mild cognitive impairment * Fluent in English * processing speed impairment
Exclusion criteria
* prior stroke or neurological disease * currently taking steroids and/or benzodiazepines * history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or pyschosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder * significant alcohol or drug abuse history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symbol-Digit Modalities Test | Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention | Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TBI Quality of Life, Depression scale | Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention | Change in scores on self-report of emotional functioning, measured via questionnaire. The TBI QOL Depression scale measures depression. The range is 1-40. A higher score indicates greater depression. |
| Perceived Deficits Questionnaire | Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention | Change in scores on self-report of perceived cognitive deficits in daily life, measured via questionnaire. A higher score indicates greater perceived deficits in daily life. Range of scores on the scale is 0-80. |
| TBI Quality of Life, Total Score | Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention | Change in scores on self-report of quality of life, measured via questionnaire. DV is the TBI-QOL total score. The range is 1-40. A higher score indicates better quality of life. |
Countries
United States
Outcome results
None listed