Post-Traumatic Stress DisorderNCT00928941
Neural Correlates of Cognitive Rehabilitation in Post-Traumatic Stress Disorder (PTSD)
A study testing cognitive training and video game in people with Post-Traumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- cognitive training and video game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OEF/OIF Veteran,
- meets DSM-IV criteria for PTSD,
- control group does not meet criteria for PTSD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
Official title: Neural Correlates of Cognitive Rehabilitation in PTSD
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.
Read the detailed description
- Objective(s) Post Traumatic Stress Disorder (PTSD) has been established as relatively common in a significant number of OEF/OIF Veterans (Vasterling \& Brailey, 2005; Hoge et al., 2008). Attention deficits, which are prominent in PTSD, may be due to difficulty sustaining attention over time and encoding or getting information into storage which leads to reduced attention and memory scores on neuropsychological measures. Disruptions in attention are common in many types of neurological and psychiatric disorders. Deficient attentional skills may negatively affect cognitive performance in other areas (e.g., memory, planning) and thereby reduce effectiveness navigating daily life tasks as well as decrease the Veteran's life satisfaction after returning home. The origin of the attention impairment may be amenable to sophisticated remediation approaches using a "bottom up, neuroscience based" visual training program (i.e., Posit Science, Inc. cognitive rehabilitation program), which has been successful in improving neurocognitive function in healthy older adults (e.g., Mahncke et al., 2006) and patients with Schizophrenia (e.g., Bell at al., 2008). By engaging Veterans with PTSD in targeted remediation, it is expected that both behavioral (seen in neuropsychological test gains) and neural activity (e.g., BOLD response through fMRI) will reflect the improvement and this may be linked to improved outcomes in daily functioning.
- Research Design: The longitudinal research design for this project will be a three factor mixed factorial design with between subject factors of PTSD (+PTSD x -PTSD) and cognitive remediation [cogrem x video game] and within subject variable of time tested (pre-training, post-training, 3 month follow up). There will be 40 participants enrolled in the following groups of 10 each: 1) +PTSD/cogrem, 2) +PTSD/video game, 3) -PTSD/cogrem, and 4) -PTSD/video game. PTSD status is determined by a diagnosis of PTSD identified through a clinical interview for DSM-IV diagnostic criteria for PTSD. The active treatment is cognitive training. Veterans in this group will receive the Posit Science (Mahncke et al., 2006) visual cognitive remediation paradigm of 40 hours of training. The control treatment is a video game designed by Nintendo for the DS handheld system, which intended to improve mental functioning called Brain Age (Nintendo, Inc.) which will be played for 40 hours. Groups will be compared on the difference scores for neuropsychological, neurobehavioral and neuroimaging data to see if there is a benefit in cognitive training and if that benefit is greater in the group with PTSD.
- Methodology: Forty outpatient Veterans will be enrolled. All individuals will receive a neurobehavioral interview, neuropsychological testing and neuroimaging at the baseline visit, post training and at follow-up visits. After the baseline visit, each volunteer will be randomized to one of two conditions.
- Findings: This is a new study and there are no findings to date.
- Clinical Relationships: This study will examine the effects of a standard cognitive rehabilitation program with OEF/OIF veterans who have cognitive deficits due to PTSD.
- This project will impact veterans' healthcare by identifying cognitive problems in PTSD and will test the ability of a rehabilitation program to remediate those problems.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- cognitive training, video game
- Keywords
- PTSD, rehabilitation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive trainingBehavioural
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.
video gameBehavioural
An active control condition (computer game without increasing difficulty) will be implemented for at least 3-4 hours a week for 40 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychological test data
Measured: post-training and 3 month follow up
Secondary outcomes (1)
MRI data
Measured: post-training and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: The PI has left the project and the VA, as of 3/2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kristen Wrocklage, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928941
- Sponsor's protocol ID
- B7009-M
- Other IDs
- B7009-M
- Status last verified
- Dec 2014
- First submitted
- 22 Jun 2009
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Cognitive Rehabilitation in PTSD
- ClinicalTrials.gov ID
- NCT00928941
- Acronym / sponsor ID
- B7009-M
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI has left the project and the VA, as of 3/2011
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Jun 2009 (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.
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.
Detailed description
- Objective(s) Post Traumatic Stress Disorder (PTSD) has been established as relatively common in a significant number of OEF/OIF Veterans (Vasterling \& Brailey, 2005; Hoge et al., 2008). Attention deficits, which are prominent in PTSD, may be due to difficulty sustaining attention over time and encoding or getting information into storage which leads to reduced attention and memory scores on neuropsychological measures. Disruptions in attention are common in many types of neurological and psychiatric disorders. Deficient attentional skills may negatively affect cognitive performance in other areas (e.g., memory, planning) and thereby reduce effectiveness navigating daily life tasks as well as decrease the Veteran's life satisfaction after returning home. The origin of the attention impairment may be amenable to sophisticated remediation approaches using a "bottom up, neuroscience based" visual training program (i.e., Posit Science, Inc. cognitive rehabilitation program), which has been successful in improving neurocognitive function in healthy older adults (e.g., Mahncke et al., 2006) and patients with Schizophrenia (e.g., Bell at al., 2008). By engaging Veterans with PTSD in targeted remediation, it is expected that both behavioral (seen in neuropsychological test gains) and neural activity (e.g., BOLD response through fMRI) will reflect the improvement and this may be linked to improved outcomes in daily functioning.
- Research Design: The longitudinal research design for this project will be a three factor mixed factorial design with between subject factors of PTSD (+PTSD x -PTSD) and cognitive remediation [cogrem x video game] and within subject variable of time tested (pre-training, post-training, 3 month follow up). There will be 40 participants enrolled in the following groups of 10 each: 1) +PTSD/cogrem, 2) +PTSD/video game, 3) -PTSD/cogrem, and 4) -PTSD/video game. PTSD status is determined by a diagnosis of PTSD identified through a clinical interview for DSM-IV diagnostic criteria for PTSD. The active treatment is cognitive training. Veterans in this group will receive the Posit Science (Mahncke et al., 2006) visual cognitive remediation paradigm of 40 hours of training. The control treatment is a video game designed by Nintendo for the DS handheld system, which intended to improve mental functioning called Brain Age (Nintendo, Inc.) which will be played for 40 hours. Groups will be compared on the difference scores for neuropsychological, neurobehavioral and neuroimaging data to see if there is a benefit in cognitive training and if that benefit is greater in the group with PTSD.
- Methodology: Forty outpatient Veterans will be enrolled. All individuals will receive a neurobehavioral interview, neuropsychological testing and neuroimaging at the baseline visit, post training and at follow-up visits. After the baseline visit, each volunteer will be randomized to one of two conditions.
- Findings: This is a new study and there are no findings to date.
- Clinical Relationships: This study will examine the effects of a standard cognitive rehabilitation program with OEF/OIF veterans who have cognitive deficits due to PTSD.
- This project will impact veterans' healthcare by identifying cognitive problems in PTSD and will test the ability of a rehabilitation program to remediate those problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: cognitive trainingA 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. |
| Arm 2 | Active comparator | Behavioral: video gameA computer game control condition will be implemented for 3-4 training exercises a week for 40 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OEF/OIF Veteran,
- meets DSM-IV criteria for PTSD,
- control group does not meet criteria for PTSD
Key exclusion criteria (8 listed)
- 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:
- 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
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 |
|---|---|---|
| cognitive trainingA 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. | Behavioural | Arm 1 |
| video gameAn active control condition (computer game without increasing difficulty) will be implemented for at least 3-4 hours a week for 40 hours. | Behavioural | Arm 2 |
Primary outcome
neuropsychological test data
Time frame: post-training and 3 month follow up
1 secondary outcome
MRI data
Time frame: post-training and 3 month follow up
Results and safety
The study was stopped early (reason given: The PI has left the project and the VA, as of 3/2011). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
Kristen Wrocklage, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training and video game in people with Post-Traumatic Stress Disorder, run by US Department of Veterans Affairs 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 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. 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?
The study was stopped early (reason given: The PI has left the project and the VA, as of 3/2011). 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?
neuropsychological test data (time frame: post-training and 3 month follow up). 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 10 Dec 2014.