Enhancing Cognitive Function and Reintegration in Iraq and Afghanistan Veterans With Post Traumatic Stress Disorder (PTSD) Using Computer-Based Cognitive Training

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Karen Seal, San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier:
NCT01087775
First received: March 15, 2010
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cognitive Impairment
Behavioral: Cognitive Training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Cognitive Function and Reintegration in Iraq and Afghanistan Veterans With PTSD Using Computer-Based Cognitive Training

Resource links provided by NLM:


Further study details as provided by San Francisco Veterans Administration Medical Center:

Primary Outcome Measures:
  • standard (untrained) neurocognitive measures (verbal memory, learning and sustained attention) [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • social and occupational functioning and quality of life scores [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
  • community reintegration scores [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Training
Plasticity Based Adaptive Cognitive Remediation (PACR)
Behavioral: Cognitive Training
Plasticity Based Adaptive Cognitive Remediation (PACR)
Other Name: Plasticity Based Adaptive Cognitive Remediation (PACR)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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:

    1. Confirmed OEF and/or OIF military service
    2. Male veterans, ages 18 to 40 years with 12 to 16 years of education
    3. History of a prior positive PTSD screen or diagnosis either by SFVAMC study referral or self-report'
    4. Able and willing to travel to SFVAMC
    5. 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:

    1. 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
    2. 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:

    1. Meet threshold criteria for current full or sub-syndromal PTSD by DSM-IV criteria 31
    2. 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:

    1. Poor English comprehension and fluency
    2. Unstable medical condition, injury or disability, including moderate to severe TBI (by self-report) and hearing impairment
    3. 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:

    1. Drug and alcohol dependence and other unstable serious mental illness (e.g. psychosis) (assessed using the MINI)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087775

Locations
United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
Karen Seal
Investigators
Principal Investigator: Karen H Seal, MD San Francisco VA Medical Center
  More Information

No publications provided

Responsible Party: Karen Seal, Principle Investigator, San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier: NCT01087775     History of Changes
Other Study ID Numbers: Seal_BFP
Study First Received: March 15, 2010
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board UCSF CHR
United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Cognition Disorders
Anxiety Disorders
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on August 28, 2014