Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Traumatic Brain Injury; Mild Cognitive Impairment
• Interventions: Behavioral: Placebo Control; Behavioral: Speed of Processing Training

• Registration Number: NCT02020564
• Lead Sponsor: Kessler Foundation

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.

Study Timeline

• Study Start: 2012-12-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-24
• Study First Posted: 2013-12-25
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo control group	Placebo Control	Computerized exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Treatment Group	Speed of Processing Training	Computerized exercised will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States