Clinical trial NCT02020564: Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment
Official title: Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Mild Cognitive Impairment
Keywords: Processing Speed
Cognition
Intervention
Traumatic Brain Injury
Mild Cognitive Impairment
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symbol-Digit Modalities Test
timeFrame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Secondary outcomes:
measure: TBI Quality of Life, Depression scale
timeFrame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
measure: Perceived Deficits Questionnaire
timeFrame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
measure: TBI Quality of Life, Total Score
timeFrame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: