Strategic Memory and Reasoning Training for Cognitive Problems

NCT04554537 | Completed

• 1 other identifier: SMART
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The focus of this study is to test a treatment program (Strategic Memory Advanced Reasoning Training; SMART) that was developed to address specific brain functions found to be crucial for the recovery following traumatic brain injury (TBI). New research has shown that when these very specific brain functions are targeted, such as ability to focus on a task while ignoring irrelevant information, brain changes are more significant. SMART emphasizes top-down processing by targeting focused attention, assimilation of information, and mental flexibility and innovation, all higher-order cognitive functions driven by the frontal lobes. Evidence from other top-down cognitive training programs demonstrates their effectiveness in improving cognitive and daily functioning in individuals reporting a TBI. In addition to improving frontal lobe capacity, SMART has also been shown to increase brain blood flow critical for complex thinking and strengthen white matter integrity. The effectiveness of SMART has been extensively tested with a variety of populations, including healthy adults and adolescents, adolescents with brain injuries, healthy seniors and those at risk for Alzheimers, and veterans and civilians with lingering impairment following TBIs. This will be the first study to test its effectiveness with individuals with mild TBI (MTBI) and posttraumatic stress disorder (PTSD). The SMART program has previously been tested with patients with TBI using an 18-hour training format. When compared to the Brain Health Workshop (BHW), an education-based active learning module, participants in the SMART group (n = 31) demonstrated improvements in gist reasoning, executive function, and memory, generalization of improvement to daily functioning activities and continuation of these gains 6 months posttraining. The training consisted of 15 hours of training conducted over 10 group sessions in the first 5 weeks and a final 3 hours of training at spaced intervals over the next 3 weeks. SMART training has not been tested with patients with PTSD-related neuropsychological impairments. The purpose of the current study is to investigate the efficacy of a shortened training program (9 hours) in improving neurocognitive function in patients with mTBI and/or PTSD.

Conditions

Traumatic Brain Injury; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (13)

• CHANGE in Digit Span test of the Wechsler Adult Intelligence Scale - Fourth Edition

  Digit Span requires participants to repeat digits forwards, backwards, and sequences in ascending order; the combined score of these three tasks was used, which is then converted to a scaled score with a range of 1 to 19. Higher scores represent better performance.

  Pre-training, immediately post-training and six months later

• CHANGE in Digit Symbol and Symbol Search tests, which comprise the Processing Speed Index of the WAIS-IV

  To assess processing speed and visual-motor coordination. The Processing Speed Index is a standard score with a range of 50 to 150 with higher scores indicating better performance.

  Pre-training, immediately post-training and six months later

• CHANGE in California Verbal Learning Test

  Participants hear a word list over five trials and repeat back as many words as they can remember; the sum of trials 1-5 serves as a measure of immediate verbal memory and the delayed memory for the words 20 minutes later serves as a measure of delayed verbal memory. Scores are converted from raw scores to T scores. T scores have a range of 20 to 80, with higher scores representing bettery performance.

  Pre-training, immediately post-training and six months later

• CHANGE in Logical Memory task of the Wechsler Memory Scale, 4th edition

  assess verbal learning and memory in a narrative context. Participants were presented with a short story and asked to repeat back as much of the story as possible immediately after. Details of the stories are totaled and raw scores are converted to scaled scores. Both immediate memory and delayed memory received a scaled score, range from 1 to 19 with higher scores indicating better performance.

  Pre-training, immediately post-training and six months later

• CHANGE in Brief Visuospatial Memory Test-Revised

  a measure of immediate and delayed visuospatial memory. The participant must memorize a series of designs over three trials and recreate them from memory, both immediately following display and after a delay of 20 minutes. A sum of Trials 1-3 represents the immediate raw score which is then converted to a T score. The T scores have a range of 20 to 80, with higher scores indicating better performance.

  Pre-training, immediately post-training and six months later

• CHANGE in Trail Making Test of the Delis-Kaplan Executive Functioning System

  Assess cognitive flexibility, verbal fluency, inhibitory control. There are five conditions, and the final condition, the "switching condition" is the score used. It is a measure of seconds taken to complete the task which is then converted to a scaled score, with a range of 1 to 19, with higher scores representing better performance.

  Pre-training, immediately post-training and six months later

• CHANGE in Test of Strategic Learning

  The TOSL involves synthesizing gist meaning from complex information. Participants read a complex passage and are instructed to generate a high-level summary of what they read. Three scores are generated and are presented as raw scores, with higher scores indicating better performance. The summary abstraction score reflects the total number of accurately abstracted meanings from the reading; the high-level lessons score measures the number of high-level lessons the participants gleaned from the story; and the detail total score measures participants' memory for the story's detail-based information.

  Pre-training, immediately post-training and six months later

• CHANGE in Neurobehavioral Symptom Inventory (NSI)

  22-item self-report measure of postconcussive symptoms. We specifically examined the Cognitive subscale of the NSI at all time points. The range for this scale is 0 to 20, with higher scores indicating more self-reported impairment

  Pre-training, immediately post-training and six months later

• CHANGE in Clinician Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5

  Assesses posttraumatic stress diagnosis and symptoms. Range of scores is 0 to 80 with higher scores indicating higher PTSD symptom severity.

  Pre-training, immediately post-training and six months later

• CHANGE in Paced Auditory Serial Addition Test

  To assess working memory, sustained attention, and divided attention, participants were asked to listen to an audio tape presenting a series of single-digit numbers and then state aloud the sum of the number more recently presented plus the number preceding it. There were two trials and the number of correct answers for both trials is summed. Higher scores indicated better performance.

  Pre-training, immediately post-training and six months later

• CHANGE in Continuous Performance Test performance

  To assess sustained attention, vigilance, inhibitory control, and inattention, the computer-based Conners' Continuous Performance Test 3rd Edition was administered. Errors of omission are a measure of sustained attention and errors of commission are a measure of inhibitory control. Raw scores are converted to T scores. Higher scores indicate more omissions and commissions, or poorer performance.

  Pre-training, immediately post-training and six months later

• CHANGE in Delis-Kaplan Executive Functioning System Color-Word Interference Test performance

  To assess change in inhibitory control and cognitive flexibility, the "interference condition" of the Color-Word Test was used. Raw scores are converted to scaled scores, with a range of 1 to 19 with higher scores representing better performance.

  Pre-training, immediately post-training and six months later

• CHANGE in Delis-Kaplan Executive Functioning System Verbal Fluency performance

  To assess change in verbal fluency, two tasks were administered: the Letter Fluency subtest and the Category Fluency subtest. Raw scores are converted into scaled scores, with a range of 1 to 19 with higher scores representing better performance.

  Pre-training, immediately post-training and six months later

Secondary Outcomes (2)

• Change in subjective cognitive complaints

  Pre-training, immediately post-training and six months later

• Change in Quality of Life

  Pre-training, immediately post-training and six months later

Study Arms (2)

Brain Health Workshop

PLACEBO COMPARATOR

The BHW training has been used in multiple prior studies as a comparison training program in cognitive training trials It consists of sessions of fact-based information about the brain but does not train cognitive strategies. Topics include neuroanatomy, neuroplasticity, and effects of TBI on cognitive functioning. Other sessions focus on diet, exercise, sleep, and social functioning and their relationships to brain health. Participants are encouraged to share how the topics impact their lives. Participants are given take-home reading materials on related topics that were then discussed at the last session. At home, they were instructed to watch assigned videos but had no other homework.

Behavioral: Brain Health Workshop

SMART

EXPERIMENTAL

SMART emphasizes top-down processing by targeting focused attention, assimilation of information, and mental flexibility and innovation, all higher-order cognitive functions driven by the frontal lobes. SMART was delivered in small groups (n = 2 to 8) consisting of two 3-hour sessions over two days, followed by one 3-hour session a month later. Overall, sessions focused on strategic attention, integrative reasoning, and cognitive control functions (Chapman, 2014). Training consists of initial sessions of skills training with the one-month follow-up session being a "booster session" consisting of review. We modified the training such that all sessions included skills training with briefer review. The first two sessions consisted of strategic attention and integrated reasoning and the final session discussed innovation.

Behavioral: SMART

Interventions

SMART BEHAVIORAL

A treatment program developed to address specific brain functions found to be crucial for the recovery following brain injury.

Also known as: Strategic Memory Advanced Reasoning Training

SMART

Brain Health Workshop BEHAVIORAL

A psychoeducation program designed to provide in depth information to participants about the neuroscience behind their TBI and PTSD and the symptoms and challenges they may experience.

Brain Health Workshop

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults between the ages of 19 to 65 years
• speak and comprehend English, as not all of the standardized cognitive tests have been normed for non-English speakers
• diagnosis of either mild or moderate TBI (as defined by OSU TBI interview) and/or diagnosis of subthreshold or full PTSD (as determined by Clinician-Administered PTSD Scale)

You may not qualify if:

• someone who is not proficient in reading, comprehending, and speaking English
• self-report on phone screen interview of pre-existing cerebral palsy, intellectual disability, autism, epilepsy, schizophrenia, stroke, pervasive developmental disorder, or a diagnosed learning disability
• history of psychotic disorder or bipolar disorder (by self-report)
• current alcohol or drug dependence (by self-report)
• severe TBI (determined by OSU TBI interview)
• participants who are determined by the TOMM (more than five errors on Trial 2 or the Retention trial) to be malingering neuropsychological problems
• neuropsychological testing or r any cognitive training in the past 3 months as this could introduce practice effects.

Sponsors & Collaborators

• Dr. Kristin Samuelson: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kristin W Samuelson, PhD

  UCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: September 18, 2020
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share