Clinical trial NCT04554537: Strategic Memory and Reasoning Training for Cognitive Problems
Official title: Strategic Memory and Reasoning Training for Cognitive Problems Due to Mild Traumatic Brain Injury and Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Posttraumatic Stress Disorder
Lead sponsor: University of Colorado, Colorado Springs
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: DESIGN: This is a double-blind, randomized controlled clinical trial. A total of 150 adults ages 19-65 years with Traumatic Brain Injury (TBI) and/or subthreshold of full diagnosis of posttraumatic stress disorder (PTSD) will be recruited for the study (estimated 100 completers). They will be read the telephone recruitment script (attached) and asked questions that determine whether or not they are eligible for the study. Eligible participants will be randomized into either SMART training or the Brain Health Workshop as a control condition. All the participants will go through the neuropsychological testing and clinical interviews before and after the treatment program and six months later to assess long terms changes. These testing procedures are explained below. During the treatment program, SMART participants will participate in a 6-hour program over a 1-week period (two 3-hour sessions), and one 3-hour booster session a month later. Participants in the Brain Health Workshop condition will attend sessions that include education on brain topics of the same duration. TESTING SESSIONS: Participants will attend an initial eligibility visit and a second visit in which they will complete neuropsychological tests. They will also complete a packet of self-report questionnaires at home in between the first two visits (listed in section 2c below). At the initial eligibility visit, they will met with a clinical interviewer/neuropsychological technician (a graduate student working under Dr. Samuelson's supervision) who will administer the following measures:Clinician-Administered PTSD Scale (CAPS),Brief Pain Inventory - Short Form (BPI-SF), Glasgow Outcome Scale - Extended (GOSE),Ohio State University TBI Identification Method (OSU-TBI-ID), NIH Toolbox Standing Balance Test (motor),and Test of Memory Malingering Trial. These measures will determine eligibility for the study (i.e., diagnosis of TBI and/or subthreshold or full PTSD, no diagnosis of psychosis, bipolar disorder, or substance dependence, and no malingering). At the second visit, the technician will administer neuropsychological tests , which will take 2.5 to 3 hours: Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding, WAIS-IV Symbol Search, WAIS-IV Digit Span, Wechsler Memory Scale-IV (WMS-IV) Logical Memory, Test of Strategic Learning (TOSL),Visual Selective Learning Task, Go/No-Go, WMS-IV Logical Memory II, WAIS-IV Vocabulary, WAIS-IV Similarities, WAIS-IV Matrix Reasoning, Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test, D-KEFS Color-Word Interference Test , D-KEFS Trail Making Test, Brief Visuospatial Memory Test - Revised (BVMT), Rey Complex Figure Test \& Recognition Trial (RCFT), Animal Fluency-Verbal, California Verbal Learning Test, Controlled Oral Word Association (COWAT) , Wide Range Achievement Test-4 (WRAT-4) Word Reading, Paced Auditory Serial Addition Test (PASAT). TREATMENT: Following baseline testing sessions, the participants will be randomly assigned to either SMART or Brain Health Workshop (BHW). In the SMART treatment condition, participants will be taught new strategies in a group setting to improve brain functions such as critical thinking, reasoning, problem solving and improved comprehension of information. To accomplish improvement in these brain functions, participants will be involved in activities such as analyzing information from a book, or a newspaper article, writing comprehensive passages etc. Training will also include application of these strategies to other daily activities. In this treatment group, participants will also be given homework assignments for each session including maintaining a journal, provided by the clinician to record the use of the strategies taught in the treatment sessions in their daily activities and the homework provided by the clinician. The intervention will be a total of 9 hours - 6 hours over the course of one week and then a 3-hour booster session a month later. Post-testing occurs within one week of the booster session. In the BHW condition, participants will be taught topics about the brain in a similar format to SMART. Topics include anatomy, neurotransmitters, effects of TBI on cognitive functioning, and principles of neuroplasticity. Participants will also be given take-home reading assignments and quizzed on the readings at the beginning of the following session. Post-Treatment: Following the interventions patients will repeat the assessments (except for Test of Memory Malingering (TOMM), and TBI interviews) identical to the pre-treatment assessment within one week of completing the intervention. This testing session will occur in 1 day and take approximately 3.25 to 4 hours. Participants will be tested again at 6 months following the intervention with the same tests.

Eligibility criteria: Inclusion Criteria:Inclusion criteria include .

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: CHANGE in Digit Span test of the Wechsler Adult Intelligence Scale - Fourth Edition
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Digit Symbol and Symbol Search tests, which comprise the Processing Speed Index of the WAIS-IV
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in California Verbal Learning Test
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Logical Memory task of the Wechsler Memory Scale, 4th edition
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Brief Visuospatial Memory Test-Revised
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Trail Making Test of the Delis-Kaplan Executive Functioning System
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Test of Strategic Learning
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Neurobehavioral Symptom Inventory (NSI)
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Clinician Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Paced Auditory Serial Addition Test
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Continuous Performance Test performance
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Delis-Kaplan Executive Functioning System Color-Word Interference Test performance
timeFrame: Pre-training, immediately post-training and six months later
measure: CHANGE in Delis-Kaplan Executive Functioning System Verbal Fluency performance
timeFrame: Pre-training, immediately post-training and six months later
Secondary outcomes:
measure: Change in subjective cognitive complaints
timeFrame: Pre-training, immediately post-training and six months later
measure: Change in Quality of Life
timeFrame: Pre-training, immediately post-training and six months later
Other outcomes:
Locations:
Study officials:
affiliation: UCCS
name: Kristin W Samuelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: