Posttraumatic Stress DisordersNCT01644851
Cognitive Training for Post Traumatic Stress Disorder: Effects on Cognitive, Emotional, and Brain Function
A study testing Executive function training in people with Posttraumatic Stress Disorders, run by University of Missouri, Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Executive function training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- combat veterans who served in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation New Dawn
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Univesity of Missouri - Kansas City
Kansas City, Missouri, 64110
About this study
Official title: 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Executive function training
- Keywords
- veterans, neuropsychology, neuroimaging, attention, working memory, inhibition, magnetic resonance imaging, functional, trauma, stress, anxiety, emotion, prefrontal cortex
- Medical subject headings
- Stress Disorders, Post-Traumatic, Inhibition, Psychological, Wounds and Injuries, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive function trainingBehavioural
Computer-based training in executive functions, administered via www.lumosity.com website.
| Study group | Role | What they receive |
|---|---|---|
| Executive function training | Experimental | Executive function training Receives: Behavioral: Executive function training |
| Word game training | Placebo comparator | Computer-based training in tasks related to verbal processing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural activity in prefrontal regions during cognitive and emotional processing measured by functional magnetic resonance imaging.
Measured: change from baseline to after 6 weeks of training
Secondary outcomes (1)
Cognitive functioning as measured by neuropsychological assessment.
Measured: change from baseline to after 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas
- Responsible party
- Principal investigator, Robin Aupperle, University of Missouri, Kansas City
- Investigators
- Robin Aupperle, PhD, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644851
- Sponsor's protocol ID
- UMKC SS11-212e
- Status last verified
- Dec 2014
- First submitted
- 17 Jul 2012
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training for PTSD: Effects on Cognitive, Emotional, and Brain Function
- ClinicalTrials.gov ID
- NCT01644851
- Acronym / sponsor ID
- UMKC SS11-212e
- Conditions
- Posttraumatic Stress Disorders
- Keywords
- veterans, neuropsychology, neuroimaging, attention, working memory, inhibition, magnetic resonance imaging, functional, trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- University of Kansas
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive function training | Experimental | Behavioral: Executive function trainingExecutive function training |
| Word game training | Placebo comparator | –Computer-based training in tasks related to verbal processing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- combat veterans who served in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation New Dawn
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Executive function trainingComputer-based training in executive functions, administered via www.lumosity.com website. | Behavioural | Executive function training |
Primary outcome
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
1 secondary outcome
Cognitive functioning as measured by neuropsychological assessment.
Time frame: change from baseline to after 6 weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Aupperle, PhD principal investigator
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive function training in people with Posttraumatic Stress Disorders, run by University of Missouri, Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.