Overview

This trial is active, not recruiting.

Condition cognitive impairment
Treatment cognitive training
Sponsor Karen Seal
Start date April 2010
End date September 2014
Trial size 50 participants
Trial identifier NCT01087775, Seal_BFP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Plasticity Based Adaptive Cognitive Remediation (PACR)
cognitive training Plasticity Based Adaptive Cognitive Remediation (PACR)
Plasticity Based Adaptive Cognitive Remediation (PACR)

Primary Outcomes

Measure
standard (untrained) neurocognitive measures (verbal memory, learning and sustained attention)
time frame: 6 month follow-up

Secondary Outcomes

Measure
social and occupational functioning and quality of life scores
time frame: 6 month follow-up
community reintegration scores
time frame: 6 month follow-up

Eligibility Criteria

Male participants from 18 years up to 40 years old.

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)

Additional Information

Official title Enhancing Cognitive Function and Reintegration in Iraq and Afghanistan Veterans With PTSD Using Computer-Based Cognitive Training
Principal investigator Karen H Seal, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by San Francisco Veterans Administration Medical Center.