GAME Veterans With PTSD Using Computer-Based Cognitive Training

NCT01087775 | Completed Results DMC

• 1 other identifier: W81XWH1020078
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  6-month follow-up

Secondary Outcomes (1)

• Social and Occupational Functioning and Quality of Life Scores at 6 Months

  6 month follow-up

Study Arms (1)

Cognitive Training

EXPERIMENTAL

Plasticity Based Adaptive Cognitive Remediation (PACR)

Behavioral: Cognitive Training

Interventions

Cognitive Training BEHAVIORAL

Plasticity Based Adaptive Cognitive Remediation (PACR)

Also known as: Plasticity Based Adaptive Cognitive Remediation (PACR)

Cognitive Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Drug and alcohol dependence and other unstable serious mental illness (e.g. psychosis) (assessed using the MINI)

Sponsors & Collaborators

• Karen Seal: lead

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Karen Seal
• Organization: San Francisco VA Medical Center

Karen.Seal@va.gov

4152214810

Study Officials

• Karen H Seal, MD

  San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 23, 2019
• Results First Posted: December 5, 2019

Record last verified: 2019-12

Locations

US (1)