San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121, United States
NCT Number: NCT01087775
The investigators hypothesis are as follows:
H1a: OEF/OIF veterans with PTSD who perform cognitive training (CT) will demonstrate greater objective improvements on standard (untrained) neurocognitive measures, with the largest gains in verbal memory, learning and sustained attention.
H1b: Objective cognitive improvements in CT participants will be sustained at three months post-intervention, suggesting persistence of neuroplasticity-based cognitive training benefits.
H2a: OEF/OIF veterans with PTSD who perform CT will report greater improvements in cognitive function.
H2b: OEF/OIF veterans with PTSD who perform CT will demonstrate improved social and occupational functioning and quality of life.
H2c: OEF/OIF veterans with PTSD who perform CT will demonstrate greater improvements in community reintegration.
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Notify Me18 year–40 year
Male
Interventional
Not applicable
San Francisco, California, 94121, United States
Posttraumatic Stress Disorder (PTSD)-related cognitive dysfunction is well-described and has been associated with specific impairments in verbal memory, learning, attention and emotional regulation, deficits which have been correlated with abnormalities in specific brain regions. Both PTSD and cognitive dysfunction have been associated with impairments in social and occupational functioning and may contribute to operational or battlefield errors, soldiers' safety and threaten the success of military operations. In addition, following military service separation, PTSD-related cognitive impairment adversely impacts quality of life, readjustment, and community reintegration. A computerized neuroplasticity-based auditory cognitive training program (Plasticity-Based Adaptive Cognitive Remediation, Posit Science, San Francisco, CA) has been shown in several randomized controlled trials to improve verbal memory, attention, cognitive control, quality of life and daily function in community-dwelling elders and individuals with schizophrenia. To our knowledge however, there have been no studies of cognitive remediation training in individuals with PTSD. Therefore, the overall aim of this proposal was to investigate the efficacy of neuroplasticity-based auditory cognitive training in Veterans with PTSD and cognitive dysfunction. The primary specific aim of this pilot study was to examine change in objective cognitive function in Veterans with PTSD and cognitive dysfunction who participated in an open-label trial of an auditory cognitive training program. Our secondary aim was to examine change in self-reported cognitive function, social and occupational functioning, quality of life and community reintegration in Veterans with PTSD who participate in auditory CT. Finally, we evaluated the feasibility and usability of home-based computerized auditory cognitive training in Veterans with PTSD and cognitive dysfunction. We enrolled subjects in a program of 3 months of auditory cognitive training (CT) followed by 3 months of no contact. We assessed participants' change scores on neuropsychological outcome measures from pre- to post-treatment using reliable change indicators. We utilized qualitative thematic analysis to identify themes from participants about the feasibility, acceptability, and usability of the treatment. Information derived from this pilot study may be used to inform future cognitive training interventions for Veterans.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Plasticity Based Adaptive Cognitive Remediation (PACR)
Other names: Plasticity Based Adaptive Cognitive Remediation (PACR)
Time frame: 6-month follow-up
We presented change scores (6-month scores minus baseline scores) outcomes of 10 measures of neurocognitive measures (together with ranges): the Wechsler Memory Scale (WMS-IV) Paired Associates immediate and delayed memory (range: 1-19), Rey Auditory Verbal Learning Test (RAVLT) total score (range: 0-100) and delayed score (range: 0-20), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span (range: 0-48), Wechsler Adult Intelligence Scale (WAIS-IV) Letter Number Sequencing (range: 1-19), Auditory Consonant Trigrams (ACT) raw score (range: 0-60), Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition (range: 1-19), and the Brief Visual Memory Test revised (BVMT-R) total T score and Delayed T score (range: 20-80). Higher scores mean better cognitive functioning outcomes.
Time frame: 6 month follow-up
To measure social and occupational functioning, we used the World Health Organisation Quality of Life Assessment (WHOQOL-BREF) validated to detect intervention-related change in quality of life.
Range of post-treatment domain scores:
WHOQOL physical domain: 7-35; WHOQOL psychological domain: 6-30; WHOQOL social relationships domain: 2-10; WHOQOL environment domain: 8-40.
Higher scores indicate better quality of life outcomes.
Karen Seal
Fed
Enhancing Cognitive Function and Reintegration in Iraq and Afghanistan Veterans With PTSD Using Computer-Based Cognitive Training
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