Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI
Condition: Post Traumatic Stress Disorder; Mild Traumatic Brain Injury, Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      One of the most pressing concerns within the VA currently is the provision of interventions
      that address the cognitive as well as emotional problems faced by Veterans with concurrent
      mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain
      injury influences how people think, act, and feel. This may include how people pay attention,
      keep information in memory, organize plans for achieving important goals, and manage stress.
      Another purpose of this research is to learn more about the effects of cognitive training on
      the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in
      the short- and long-term. With this research, the investigators hope to better understand and
      treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.
    

Detailed description: 
      The overall aim of this proposal is to investigate the potential short and long term
      effectiveness of a cognitive training program Goal-Oriented Attentional Self-regulation
      (GOALS) that targets executive control functions in Veterans with co-morbid posttraumatic
      stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and cognitive
      difficulties. Both PTSD and a history of mild TBI are prevalent in Veterans from the
      Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts, with reported
      rates for each disorder ranging from 14 - 22%. Both PTSD and TBI have been associated with
      cognitive dysfunction which may lead to functional impairment and poor community
      reintegration. PTSD can be highly debilitating not only due to emotional dysregulation, but
      also due to deficits in the cognitive control processes.

      Goal-Oriented Attentional Self-Regulation (GOALS) is a therapist administered cognitive
      rehabilitation training that targets executive control functions of applied mindfulness-based
      attention regulation and goal management, and links them to participant-defined real-life
      goals. In a prior study with individuals with chronic brain injury, this training has
      improved cognitive performance in areas of complex attention / executive function, memory,
      complex functional task performance, and daily functioning. Furthermore, functional MRI
      results after training indicated significantly enhanced modulation of neural processing in
      extrastriate cortex and changes in prefrontal cortex. Preliminary results from a recently
      completed study with Veterans with a history of chronic TBI also support improvements post
      GOALS on neuropsychological measures of attention and executive function, performance on
      complex 'real-life' tasks, and self-report measures of functional performance. Furthermore,
      participants also showed improvement on the emotional regulation self-report measures. These
      findings suggest that improving cognitive control may also improve functioning in other
      domains such as emotional regulation and functional performance in daily life.

      In a randomized, controlled intervention study design, 42 Veterans with a diagnosis of PTSD,
      history of mTBI and residual cognitive difficulties will participate in experimental (GOALS),
      and/or active comparison (Brain Health Education - EDU) interventions matched for time and
      intensity. Participants will be randomized to start with either 5 weeks of GOALS or EDU
      training. Those who begin with EDU will cross-over to GOALS, while those begin with GOALS
      will have 5 weeks of self-driven practice only. Both groups will participate in pre and post
      intervention measurements at baseline, weeks 5 and 10. Long-term follow-up will be at 6
      months. Pre- and post-intervention measurements will include performance on untrained:
      neuro-cognitive tests assessing targeted and non-targeted cognitive domains, complex
      functional task performance in low structure 'real-world' setting, and self-report measures
      of emotional regulation and daily functioning.
    

Intervention name(s): GOALS (Goal-Oriented Attentional Regulation); EDU (Brain Health Education)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.; Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
Other intervention name(s): EDU
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post Traumatic Stress Disorder,; Mild Traumatic Brain Injury; Concussion; Cognitive Rehabilitation