Back to resultsGAME Veterans With PTSD Using Computer-Based Cognitive Training
Primary Purpose
Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- An experienced clinical interviewer with Master's-level training will conduct first- and second-level screening to determine study eligibility for enrollment in the randomized controlled trial.
The First-Level Eligibility Screen will be conducted by phone and will apply the following inclusion criteria in an effort to recruit a homogeneous sample:
- Confirmed OEF and/or OIF military service
- Male veterans, ages 18 to 40 years with 12 to 16 years of education
- History of a prior positive PTSD screen or diagnosis either by SFVAMC study referral or self-report'
- Able and willing to travel to SFVAMC
- Able and willing to perform daily home-based computer exercises for three months.
The Second Level Eligibility Determination will occur in-person at the SFVAMC of potential participants who have met first-level screening eligibility criteria. Second-level eligibility screening will require signed informed consent (see below) before the second-level screening is conducted. During the second-level eligibility screen, consenting participants will be administered:
- The Clinician-Administered PTSD screen (CAPS) and the Mini International Neuropsychiatric Interview (MINI) 29 to assess for Diagnostic and Statistical Manual (DSM)-IV Axis I psychiatric disorders
- The VA TBI second-level screen [TBI event history and Neurobehavioral Symptom Inventory (NSI) for cognitive symptoms].30
To be eligible for enrollment in the randomized controlled, veterans at second-level screening must:
- Meet threshold criteria for current full or sub-syndromal PTSD by DSM-IV criteria 31
- Report ≥ 1 moderate or severe cognitive symptom(s) on the NSI that interfere(s) with daily function including moderate to severe poor concentration, forgetfulness, difficulty making decisions and slowed thinking.
- Because PTSD is a highly comorbid condition, eligible participants may have other comorbid stable neuropsychiatric disorders, including depression or a history of a mild traumatic brain injury.
Exclusion Criteria:
The following exclusion criteria will apply to first-level screening:
- Poor English comprehension and fluency
- Unstable medical condition, injury or disability, including moderate to severe TBI (by self-report) and hearing impairment
- Current (or past 60 day) evidence-based PTSD or cognitive remediation therapy; in contrast, stable supportive therapy for PTSD and/or other mental disorders, such as group therapy or on stable psychoactive medication (> 30 days) will be acceptable.
The following exclusion criteria will apply to second-level screening:
- Drug and alcohol dependence and other unstable serious mental illness (e.g. psychosis) (assessed using the MINI)
Sites / Locations
- San Francisco Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Training
Arm Description
Plasticity Based Adaptive Cognitive Remediation (PACR)
Outcomes
Primary Outcome Measures
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention)
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.
Secondary Outcome Measures
Social and Occupational Functioning and Quality of Life Scores at 6 Months
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01087775
Brief Title
GAME Veterans With PTSD Using Computer-Based Cognitive Training
Official Title
Enhancing Cognitive Function and Reintegration in Iraq and Afghanistan Veterans With PTSD Using Computer-Based Cognitive Training
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Seal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
Plasticity Based Adaptive Cognitive Remediation (PACR)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Other Intervention Name(s)
Plasticity Based Adaptive Cognitive Remediation (PACR)
Intervention Description
Plasticity Based Adaptive Cognitive Remediation (PACR)
Primary Outcome Measure Information:
Title
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention)
Description
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
Secondary Outcome Measure Information:
Title
Social and Occupational Functioning and Quality of Life Scores at 6 Months
Description
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.
Time Frame
6 month follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
An experienced clinical interviewer with Master's-level training will conduct first- and second-level screening to determine study eligibility for enrollment in the randomized controlled trial.
The First-Level Eligibility Screen will be conducted by phone and will apply the following inclusion criteria in an effort to recruit a homogeneous sample:
Confirmed OEF and/or OIF military service
Male veterans, ages 18 to 40 years with 12 to 16 years of education
History of a prior positive PTSD screen or diagnosis either by SFVAMC study referral or self-report'
Able and willing to travel to SFVAMC
Able and willing to perform daily home-based computer exercises for three months.
The Second Level Eligibility Determination will occur in-person at the SFVAMC of potential participants who have met first-level screening eligibility criteria. Second-level eligibility screening will require signed informed consent (see below) before the second-level screening is conducted. During the second-level eligibility screen, consenting participants will be administered:
The Clinician-Administered PTSD screen (CAPS) and the Mini International Neuropsychiatric Interview (MINI) 29 to assess for Diagnostic and Statistical Manual (DSM)-IV Axis I psychiatric disorders
The VA TBI second-level screen [TBI event history and Neurobehavioral Symptom Inventory (NSI) for cognitive symptoms].30
To be eligible for enrollment in the randomized controlled, veterans at second-level screening must:
Meet threshold criteria for current full or sub-syndromal PTSD by DSM-IV criteria 31
Report ≥ 1 moderate or severe cognitive symptom(s) on the NSI that interfere(s) with daily function including moderate to severe poor concentration, forgetfulness, difficulty making decisions and slowed thinking.
Because PTSD is a highly comorbid condition, eligible participants may have other comorbid stable neuropsychiatric disorders, including depression or a history of a mild traumatic brain injury.
Exclusion Criteria:
The following exclusion criteria will apply to first-level screening:
Poor English comprehension and fluency
Unstable medical condition, injury or disability, including moderate to severe TBI (by self-report) and hearing impairment
Current (or past 60 day) evidence-based PTSD or cognitive remediation therapy; in contrast, stable supportive therapy for PTSD and/or other mental disorders, such as group therapy or on stable psychoactive medication (> 30 days) will be acceptable.
The following exclusion criteria will apply to second-level screening:
Drug and alcohol dependence and other unstable serious mental illness (e.g. psychosis) (assessed using the MINI)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen H Seal, MD
Organizational Affiliation
San Francisco VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GAME Veterans With PTSD Using Computer-Based Cognitive Training
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