- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644851
Cognitive Training for Post Traumatic Stress Disorder: Effects on Cognitive, Emotional, and Brain Function
December 4, 2014 updated by: Robin Aupperle, University of Missouri, Kansas City
Cognitive Training for PTSD: Effects on Cognitive, Emotional, and Brain Function
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64110
- Univesity of Missouri - Kansas City
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Executive function training
|
Computer-based training in executive functions, administered via www.lumosity.com
website.
|
Placebo Comparator: Word game training
Computer-based training in tasks related to verbal processing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
change from baseline to after 6 weeks of training
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognitive functioning as measured by neuropsychological assessment.
Time Frame: change from baseline to after 6 weeks of training
|
change from baseline to after 6 weeks of training
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).
Time Frame: change from baseline to after 6 weeks of training
|
change from baseline to after 6 weeks of training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Robin Aupperle, PhD, University of Missouri, Kansas City
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
July 17, 2012
First Submitted That Met QC Criteria
July 18, 2012
First Posted (Estimate)
July 19, 2012
Study Record Updates
Last Update Posted (Estimate)
December 8, 2014
Last Update Submitted That Met QC Criteria
December 4, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMKC SS11-212e
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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