Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes in the participants' overall status
研究概览
简要总结
This project will examine if computerized cognitive remediation will improve working memory and attention in 25 adults with a mild, moderate, or severe brain injury and compare their cognitive performance to the control group of 25 adults with a mild, moderate, or severe brain injury. The control group will train on computerized Brain Games. Participants in both groups will be assessed prior to training and immediately post-training and one month-post training.
详细描述
The study design will be randomized assignment with a control group. Participants in both groups will undergo three cognitive assessments at baseline, at the end of 30 cognitive training modules, and 1-month post-completion of the first follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically documented mild, moderate, or severe TBI;
- •All subjects will be older than 18 years of age;
- •Free from schizophrenia or bipolar disorder, due to the potential influence of such disorders on cognitive functioning;
- •Free of current alcohol or drug abuse;
- •At least 12 months post-injury.
排除标准
- •Younger than 18 years old.
- •A brain injury that is not medically documented.
- •Being diagnosed with schizophrenia or bipolar disorder.
- •Current alcohol or drug use diagnosis
- •Less than 3 months post-injury
研究组 & 干预措施
BrainHQ Cognitive Training Arm
BrainHQ Cognitive Training Arm Participants will be randomized into the BrainHQ Cognitive Training modules which are 35 minute training sessions. There will be 30 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked if they have a quiet space and noise cancelling headphones. Participants will complete the training protocols remotely and their performance will be tracked. Participants will complete the 30 training sessions remotely, but will meet with the study team member online prior to beginning the exercises and right after completing the session.
干预措施: BrainHQ Cognitive Training Modules (Behavioral)
BrainHQ People Skills Arm
Participants will be randomized into the BrainHQ's Brain Game exercises which are 35 minute training sessions. There will be 30 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked to complete the training in a quiet space and time to complete these activities. Participants will complete the 30 training sessions remotely, but will meet with the study team member online each training session prior to beginning the exercises and right after completing the exercises.
干预措施: BrainHQ People Skills Modules (Behavioral)
结局指标
主要结局
Changes in the participants' overall status
时间窗: baseline, 1 week post training, 4 weeks post training
Will be gauged by using the Promis Global Health Questionnaire. This is a standardized questionnaire that evaluates physical, mental and social health deficits common in people with brain injuries.
Change in participants' verbal attention.
时间窗: baseline, 1 week post training, 4 weeks post training
Will be assessed with the Woodcock-Johnson - Understanding Directions subtest which is a measure of verbal attention. Participant are provided oral directions to point to different parts of pictures.
Change in participants' attention and verbal memory
时间窗: baseline, 1 week post training, 4 weeks post training
Actual Reality Performance test is a measure of attention and verbal memory, which requires the participants to follow directions and sequence steps of computerized task.
Changes to participants' ability to understand social cues
时间窗: baseline, 1 week post training, 4 weeks post training
Awareness of Social Inference Test (TASIT)- Short version: is a standard measure to recognize emotions and a speaker's intentions presented in a vignette.
Change in participants' sense of depression
时间窗: baseline, 1 week post training, 4 weeks post training
This will be self reported using the Beck's Depression Inventory - II. This is a standardized instrument for the assessment of depression with a self-report questionnaire.
Change in participants' sense of anxiety
时间窗: baseline, 1 week post training, 4 weeks post training
Measured by self reports with the Beck's Anxiety Inventory which is a self-report instrument for the assessment of anxiety.
Changes to participants' mental status
时间窗: baseline, 1 week post training, 4 weeks post training
Will be measured using the Lifetime Experience Questionnaire, \\ a questionnaire to determine current and past mental.
Changes in participants' daily living
时间窗: baseline, 1 week post training, 4 weeks post training
The Functional Behavior Profile Questionnaire will be used to measure daily living status. This is a standardized questionnaire regarding activities of daily living, executive functioning, participation, problems solving and social relationships.
Changes in the pattern of participants social lifestyle
时间窗: baseline, 1 week post training, 4 weeks post training
This may be assessed with the Participation Assessment with Recombined Tools-Objective Questionnaire: A standardized questionnaire about social participation.
Change in participants' logical memory after participating in BrainHQ training
时间窗: baseline, 1 week post training, 4 weeks post training
This will be measured by the Wechsler Memory Scale-IV (WMS-IV), Logical Memory subtest which is a measure of a person's ability to recall a story told to them.
Change in participants' working memory after participating in BrainHQ training
时间窗: baseline, 1 week post training, 4 weeks post training
This will be measured by the Wechsler Memory Scale-IV (WMS-IV), Digit Span subtest which is a measure of working memory in which the person maintains their attention to the list of spoken numbers and ask to recall and state the list of numbers.
Change in participants' level of reading
时间窗: baseline, 1 week post training, 4 weeks post training
This will be measured by Test of Premorbid Functioning which is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list.
Change in participants' verbal memory
时间窗: baseline, 1 week post training, 4 weeks post training
Measured by California Verbal Learning Test - II (CVLT). This test is a measure of verbal memory. A list of words is read aloud to the participants five times. After each list of words, the participant recalls the words. The participants will also be asked to recall the words from the list 20 minutes later.
Change in participants ability to assess auditory information
时间窗: baseline, 1 week post training, 4 weeks post training
This will be assessed with the Paced Auditory Serial Addition Test (PASAT) - 3 \& 2 second versions which measures complex mental manipulation by adding the two most recent numbers that are presented auditorily. There are two sets of numbers that are presented at two different speeds. The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
Change in participants' logical memory after participating in BrainHQ training
时间窗: baseline, 1 week post training, 4 weeks post training
This will be measured by the Wechsler Memory Scale-IV (WMS-IV), Logical Memory subtest which is a measure of a person's ability to recall a story told to them.
Change in participants' verbal working memory after participating BrainHQ training
时间窗: baseline, 1 week post training, 4 weeks post training
This will be measured by the Auditory Consonant Trigram (ACT), the ACT is a standard assessment measure used to evaluate working memory, attention, and cognitive interference.
Change in participants' working memory after participating in BrainHQ training
时间窗: baseline, 1 week post training, 4 weeks post training
This will be measured by the Wechsler Memory Scale-IV (WMS-IV), Digit Span subtest which is a measure of working memory in which the person maintains their attention to the list of spoken numbers and ask to recall and state the list of numbers.
Participants' vocabulary after participating in BrainHQ training
时间窗: baseline
This will be measured by the Wechsler Adult Intelligence Scale IV, Vocabulary subtest which measure the ability to define specific words.
Participants' ability to recall information
时间窗: baseline
This will be measured by the Wechsler Adult Intelligence Scale IV, Information subtest which assesses the ability to recall general knowledge and acquired facts on different topics related to science, geography, and history.
Participants' abstract reasoning
时间窗: baseline
Measured by Wechsler Adult Intelligence Scale IV, Matrix Reasoning subtest which is a measure of abstract reasoning of visually presented stimuli.
Change in participants' level of reading
时间窗: baseline, 1 week post training, 4 weeks post training
This will be measured by Test of Premorbid Functioning which is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list.
Changes in the participants' processing speed
时间窗: baseline, 1 week post training, 4 weeks post training
This will be measured by Digit Symbol Modality Test which is a is a standard assessment measure used to measure processing speed, working memory, attention, and executive functioning. The standardized oral version will be administered.
Change in participants' verbal memory
时间窗: baseline, 1 week post training, 4 weeks post training
Measured by California Verbal Learning Test - II (CVLT). This test is a measure of verbal memory. A list of words is read aloud to the participants five times. After each list of words, the participant recalls the words. The participants will also be asked to recall the words from the list 20 minutes later.
Change in participants ability to assess auditory information
时间窗: baseline, 1 week post training, 4 weeks post training
This will be assessed with the Paced Auditory Serial Addition Test (PASAT) - 3 \& 2 second versions which measures complex mental manipulation by adding the two most recent numbers that are presented auditorily. There are two sets of numbers that are presented at two different speeds. The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
Change in participants' verbal attention.
时间窗: baseline, 1 week post training, 4 weeks post training
Will be assessed with the Woodcock-Johnson - Understanding Directions subtest which is a measure of verbal attention. Participant are provided oral directions to point to different parts of pictures.
Change in participants' attention and verbal memory
时间窗: baseline, 1 week post training, 4 weeks post training
Actual Reality Performance test is a measure of attention and verbal memory, which requires the participants to follow directions and sequence steps of computerized task.
Changes to participants' ability to understand social cues
时间窗: baseline, 1 week post training, 4 weeks post training
Awareness of Social Inference Test (TASIT)- Short version: is a standard measure to recognize emotions and a speaker's intentions presented in a vignette.
Change in participants' sense of depression
时间窗: baseline, 1 week post training, 4 weeks post training
This will be self reported using the Beck's Depression Inventory - II. This is a standardized instrument for the assessment of depression with a self-report questionnaire.
Change in participants' sense of anxiety
时间窗: baseline, 1 week post training, 4 weeks post training
Measured by self reports with the Beck's Anxiety Inventory which is a self-report instrument for the assessment of anxiety.
Changes to participants' mental status
时间窗: baseline, 1 week post training, 4 weeks post training
Will be measured using the Lifetime Experience Questionnaire, \\ a questionnaire to determine current and past mental.
Changes in participants' daily living
时间窗: baseline, 1 week post training, 4 weeks post training
The Functional Behavior Profile Questionnaire will be used to measure daily living status. This is a standardized questionnaire regarding activities of daily living, executive functioning, participation, problems solving and social relationships.
Changes in the pattern of participants social lifestyle
时间窗: baseline, 1 week post training, 4 weeks post training
This may be assessed with the Participation Assessment with Recombined Tools-Objective Questionnaire: A standardized questionnaire about social participation.
Changes in the participants' overall status
时间窗: baseline, 1 week post training, 4 weeks post training
Will be gauged by using the Promis Global Health Questionnaire. This is a standardized questionnaire that evaluates physical, mental and social health deficits common in people with brain injuries.
次要结局
未报告次要终点