Strategic Memory and Reasoning Training for Cognitive Problems
Condition: Traumatic Brain Injury; Posttraumatic Stress Disorder
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Intervention name(s): SMART; Brain Health Workshop
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A treatment program developed to address specific brain functions found to be crucial for the recovery following brain injury.; 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.
Other intervention name(s): Strategic Memory Advanced Reasoning Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment