Neural Correlates of Cognitive Rehabilitation in Post-Traumatic Stress Disorder (PTSD)

NCT00928941 | Terminated

• 1 other identifier: B7009-M
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Post Traumatic Stress Disorder (PTSD) is an emotional disorder that can also lead to problems with attention and memory. Cognitive training has been successfully used to improve attention and processing speed in other patient populations as well as healthy elderly. The purpose of this study is to examine how effective cognitive training will be in Veterans with PTSD.

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD; rehabilitation

Outcome Measures

Primary Outcomes (1)

• neuropsychological test data

  post-training and 3 month follow up

Secondary Outcomes (1)

• MRI data

  post-training and 3 month follow up

Study Arms (2)

Arm 1

EXPERIMENTAL

A cognitive training program (Posit Science) or an active control (video game) will be implemented for at least 3-4 hours a week for 40 training units.

Behavioral: cognitive training

Arm 2

ACTIVE COMPARATOR

A computer game control condition will be implemented for 3-4 training exercises a week for 40 hours.

Behavioral: video game

Interventions

cognitive training BEHAVIORAL

A cognitive training program (Posit Science) or an active control (video game) will be implemented for at least 3-4 hours a week for 40 training units/hours.

Arm 1

video game BEHAVIORAL

An active control condition (computer game without increasing difficulty) will be implemented for at least 3-4 hours a week for 40 hours.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OEF/OIF Veteran,
• meets DSM-IV criteria for PTSD,
• control group does not meet criteria for PTSD

You may not qualify if:

• prior history of significant head injury (LOC \> 30 minutes) or other neurological disorder (e.g., stroke, seizure, multiple sclerosis), learning disability or confirmed diagnosis of ADHD,
• contraindication to MR imaging, failed malingering tests during testing, or a history of severe mental illness (i.e., Schizophrenia, Bipolar Disorder)
• individuals will be excluded if in the 30 days prior to the initial interview if they:
• do not have stable housing (i.e., staying in same residence),
• have medication changes or have had a psychiatric hospitalization,
• participants who meet DSM-IV criteria for substance dependence will be excluded from the study,
• individuals will also receive urine toxicology and Breathalyzer testing as the first procedure on the evaluation day (pre and post treatment and at 3 month follow up); participants who test positive for alcohol or recent substance use (e.g., methamphetamine) or report significant levels of drug or alcohol use if they are unable to abstain from substance use at three consecutive visits
• veterans who are currently engaged in therapy treatment for PTSD

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related 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

Study Officials

• Kristen Wrocklage, PhD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 26, 2009
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

US (1)