Back to resultsCognitive Training for Post Traumatic Stress Disorder: Effects on Cognitive, Emotional, and Brain Function
Primary Purpose
Posttraumatic Stress Disorders
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Executive function training
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorders focused on measuring veterans, neuropsychology, neuroimaging, attention, working memory, inhibition, magnetic resonance imaging, functional, trauma, stress, anxiety, emotion, prefrontal cortex
Eligibility Criteria
Inclusion Criteria:
- combat veterans who served in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation New Dawn
Exclusion Criteria:
- enrolled in other active treatment protocols
- current substance abuse or dependence
- current suicidal ideation
- diagnosis of a neurological disorder
- history of moderate to severe traumatic brain injury
Sites / Locations
- Univesity of Missouri - Kansas City
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Executive function training
Word game training
Arm Description
Executive function training
Computer-based training in tasks related to verbal processing.
Outcomes
Primary Outcome Measures
Neural activity in prefrontal regions during cognitive and emotional processing measured by functional magnetic resonance imaging.
Secondary Outcome Measures
Cognitive functioning as measured by neuropsychological assessment.
Full Information
NCT ID
NCT01644851
First Posted
July 17, 2012
Last Updated
December 4, 2014
Sponsor
University of Missouri, Kansas City
Collaborators
University of Kansas
1. Study Identification
Unique Protocol Identification Number
NCT01644851
Brief Title
Cognitive Training for Post Traumatic Stress Disorder: Effects on Cognitive, Emotional, and Brain Function
Official Title
Cognitive Training for PTSD: Effects on Cognitive, Emotional, and Brain Function
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, Kansas City
Collaborators
University of Kansas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this pilot study is to determine the effects of computer-based training in executive functioning compared to word games on cognitive and emotional aspects of combat-related PTSD.
Detailed Description
Many posttraumatic stress disorder (PTSD) patients either choose not to complete or do not achieve optimal response to current first-line behavioral and pharmacologic treatments. Neurocognitive research points to the potential of novel treatments targeting dorsal prefrontal function and inhibition, attention, and working memory processes. This study investigates effects of computer-based training in executive functions compared to word games on cognitive and emotional aspects of combat-related PTSD. Paper-and-pencil questionnaires, interviews, computer-administered testing, and magnetic resonance imaging will be complete before and after the intervention. Results from this pilot study will provide information concerning feasibility and treatment potential of cognitive training for PTSD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorders
Keywords
veterans, neuropsychology, neuroimaging, attention, working memory, inhibition, magnetic resonance imaging, functional, trauma, stress, anxiety, emotion, prefrontal cortex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Executive function training
Arm Type
Experimental
Arm Description
Executive function training
Arm Title
Word game training
Arm Type
Placebo Comparator
Arm Description
Computer-based training in tasks related to verbal processing.
Intervention Type
Behavioral
Intervention Name(s)
Executive function training
Intervention Description
Computer-based training in executive functions, administered via www.lumosity.com website.
Primary Outcome Measure Information:
Title
Neural activity in prefrontal regions during cognitive and emotional processing measured by functional magnetic resonance imaging.
Time Frame
change from baseline to after 6 weeks of training
Secondary Outcome Measure Information:
Title
Cognitive functioning as measured by neuropsychological assessment.
Time Frame
change from baseline to after 6 weeks of training
Other Pre-specified Outcome Measures:
Title
Clinical PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).
Time Frame
change from baseline to after 6 weeks of training
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
combat veterans who served in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation New Dawn
Exclusion Criteria:
enrolled in other active treatment protocols
current substance abuse or dependence
current suicidal ideation
diagnosis of a neurological disorder
history of moderate to severe traumatic brain injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Aupperle, PhD
Organizational Affiliation
University of Missouri, Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univesity of Missouri - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Training for Post Traumatic Stress Disorder: Effects on Cognitive, Emotional, and Brain Function
We'll reach out to this number within 24 hrs