GAME Veterans With PTSD Using Computer-Based Cognitive Training

A study testing Cognitive Training in people with Cognitive Impairment, run by Karen Seal at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The investigators hypothesis are as follows: H1a: OEF/OIF veterans with PTSD who perform cognitive training (CT) will demonstrate greater objective improvements on standard (untrained) neurocognitive measures, with the largest gains in verbal memory, learning and sustained attention. Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Cognitive Impairment
What is being tested?: Cognitive Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Sep 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

An experienced clinical interviewer with Master's-level training will conduct first- and second-level screening to determine study eligibility for enrollment in the randomized controlled trial.
The First-Level Eligibility Screen will be conducted by phone and will apply the following inclusion criteria in an effort to recruit a homogeneous sample:
Confirmed OEF and/or OIF military service
Male veterans, ages 18 to 40 years with 12 to 16 years of education
History of a prior positive PTSD screen or diagnosis either by SFVAMC study referral or self-report'
Able and willing to travel to SFVAMC

Show all 14Show fewer

Able and willing to perform daily home-based computer exercises for three months.
The Second Level Eligibility Determination will occur in-person at the SFVAMC of potential participants who have met first-level screening eligibility criteria. Second-level eligibility screening will require signed informed consent (see below) before the second-level screening is conducted. During the second-level eligibility screen, consenting participants will be administered:
The Clinician-Administered PTSD screen (CAPS) and the Mini International Neuropsychiatric Interview (MINI) 29 to assess for Diagnostic and Statistical Manual (DSM)-IV Axis I psychiatric disorders
The VA TBI second-level screen [TBI event history and Neurobehavioral Symptom Inventory (NSI) for cognitive symptoms].30
To be eligible for enrollment in the randomized controlled, veterans at second-level screening must:
Meet threshold criteria for current full or sub-syndromal PTSD by DSM-IV criteria 31
Report ≥ 1 moderate or severe cognitive symptom(s) on the NSI that interfere(s) with daily function including moderate to severe poor concentration, forgetfulness, difficulty making decisions and slowed thinking.
Because PTSD is a highly comorbid condition, eligible participants may have other comorbid stable neuropsychiatric disorders, including depression or a history of a mild traumatic brain injury.

Who cannot join

The following exclusion criteria will apply to first-level screening:
Poor English comprehension and fluency
Unstable medical condition, injury or disability, including moderate to severe TBI (by self-report) and hearing impairment
Current (or past 60 day) evidence-based PTSD or cognitive remediation therapy; in contrast, stable supportive therapy for PTSD and/or other mental disorders, such as group therapy or on stable psychoactive medication (> 30 days) will be acceptable.
The following exclusion criteria will apply to second-level screening:
Drug and alcohol dependence and other unstable serious mental illness (e.g. psychosis) (assessed using the MINI)

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121

Other trials in United States

About this study

Official title: Enhancing Cognitive Function and Reintegration in Iraq and Afghanistan Veterans With PTSD Using Computer-Based Cognitive Training

The investigators hypothesis are as follows:

H1a: OEF/OIF veterans with PTSD who perform cognitive training (CT) will demonstrate greater objective improvements on standard (untrained) neurocognitive measures, with the largest gains in verbal memory, learning and sustained attention.

H1b: Objective cognitive improvements in CT participants will be sustained at three months post-intervention, suggesting persistence of neuroplasticity-based cognitive training benefits.

H2a: OEF/OIF veterans with PTSD who perform CT will report greater improvements in cognitive function.

H2b: OEF/OIF veterans with PTSD who perform CT will demonstrate improved social and occupational functioning and quality of life.

H2c: OEF/OIF veterans with PTSD who perform CT will demonstrate greater improvements in community reintegration.

Read the detailed description

Posttraumatic Stress Disorder (PTSD)-related cognitive dysfunction is well-described and has been associated with specific impairments in verbal memory, learning, attention and emotional regulation, deficits which have been correlated with abnormalities in specific brain regions. Both PTSD and cognitive dysfunction have been associated with impairments in social and occupational functioning and may contribute to operational or battlefield errors, soldiers' safety and threaten the success of military operations. In addition, following military service separation, PTSD-related cognitive impairment adversely impacts quality of life, readjustment, and community reintegration. A computerized neuroplasticity-based auditory cognitive training program (Plasticity-Based Adaptive Cognitive Remediation, Posit Science, San Francisco, CA) has been shown in several randomized controlled trials to improve verbal memory, attention, cognitive control, quality of life and daily function in community-dwelling elders and individuals with schizophrenia. To our knowledge however, there have been no studies of cognitive remediation training in individuals with PTSD. Therefore, the overall aim of this proposal was to investigate the efficacy of neuroplasticity-based auditory cognitive training in Veterans with PTSD and cognitive dysfunction. The primary specific aim of this pilot study was to examine change in objective cognitive function in Veterans with PTSD and cognitive dysfunction who participated in an open-label trial of an auditory cognitive training program. Our secondary aim was to examine change in self-reported cognitive function, social and occupational functioning, quality of life and community reintegration in Veterans with PTSD who participate in auditory CT. Finally, we evaluated the feasibility and usability of home-based computerized auditory cognitive training in Veterans with PTSD and cognitive dysfunction. We enrolled subjects in a program of 3 months of auditory cognitive training (CT) followed by 3 months of no contact. We assessed participants' change scores on neuropsychological outcome measures from pre- to post-treatment using reliable change indicators. We utilized qualitative thematic analysis to identify themes from participants about the feasibility, acceptability, and usability of the treatment. Information derived from this pilot study may be used to inform future cognitive training interventions for Veterans.

Conditions: Cognitive Impairment
Being tested: Cognitive Training
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive TrainingBehavioural
Also called Plasticity Based Adaptive Cognitive Remediation (PACR)
Plasticity Based Adaptive Cognitive Remediation (PACR)

Study groups in NCT01087775
Study group	Role	What they receive
Cognitive Training	Experimental	Plasticity Based Adaptive Cognitive Remediation (PACR) Receives: Behavioral: Cognitive Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention)
We presented change scores (6-month scores minus baseline scores) outcomes of 10 measures of neurocognitive measures (together with ranges): the Wechsler Memory Scale (WMS-IV) Paired Associates immediate and delayed memory (range: 1-19), Rey Auditory Verbal Learning Test (RAVLT) total score (range: 0-100) and delayed score (range: 0-20), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span (range: 0-48), Wechsler Adult Intelligence Scale (WAIS-IV) Letter Number Sequencing (range: 1-19), Auditory Consonant Trigrams (ACT) raw score (range: 0-60), Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition (range: 1-19), and the Brief Visual Memory Test revised (BVMT-R) total T score and Delayed T score (range: 20-80). Higher scores mean better cognitive functioning outcomes.
Measured: 6-month follow-up

Secondary outcomes (1)

Social and Occupational Functioning and Quality of Life Scores at 6 Months
To measure social and occupational functioning, we used the World Health Organisation Quality of Life Assessment (WHOQOL-BREF) validated to detect intervention-related change in quality of life.
Range of post-treatment domain scores:
WHOQOL physical domain: 7-35; WHOQOL psychological domain: 6-30; WHOQOL social relationships domain: 2-10; WHOQOL environment domain: 8-40.
Higher scores indicate better quality of life outcomes.
Measured: 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Sep 2014

First posted16 Mar 2010 (estimated)
Study startApr 2010
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cognitive ImpairmentStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01087775
Sponsor's protocol ID: W81XWH1020078
Status last verified: Dec 2019
First submitted: 15 Mar 2010
Last updated: 23 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Cognitive Function and Reintegration in Iraq and Afghanistan Veterans With PTSD Using Computer-Based Cognitive Training
ClinicalTrials.gov ID: NCT01087775
Acronym / sponsor ID: W81XWH1020078
Conditions: Cognitive Impairment
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Karen SealUS federal agency
Study start: Apr 2010
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 16 Mar 2010 (estimated)
Results: Posted 5 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesis are as follows:

H1b: Objective cognitive improvements in CT participants will be sustained at three months post-intervention, suggesting persistence of neuroplasticity-based cognitive training benefits.

H2a: OEF/OIF veterans with PTSD who perform CT will report greater improvements in cognitive function.

H2b: OEF/OIF veterans with PTSD who perform CT will demonstrate improved social and occupational functioning and quality of life.

H2c: OEF/OIF veterans with PTSD who perform CT will demonstrate greater improvements in community reintegration.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cognitive Training	Experimental	Behavioral: Cognitive TrainingPlasticity Based Adaptive Cognitive Remediation (PACR)

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

An experienced clinical interviewer with Master's-level training will conduct first- and second-level screening to determine study eligibility for enrollment in the randomized controlled trial.
The First-Level Eligibility Screen will be conducted by phone and will apply the following inclusion criteria in an effort to recruit a homogeneous sample:
The Second Level Eligibility Determination will occur in-person at the SFVAMC of potential participants who have met first-level screening eligibility criteria. Second-level eligibility screening will require signed informed consent (see below) before the second-level screening is conducted. During the second-level eligibility screen, consenting participants will be administered:
To be eligible for enrollment in the randomized controlled, veterans at second-level screening must:
Because PTSD is a highly comorbid condition, eligible participants may have other comorbid stable neuropsychiatric disorders, including depression or a history of a mild traumatic brain injury.

Key exclusion criteria (6 listed)

The following exclusion criteria will apply to first-level screening:
The following exclusion criteria will apply to second-level screening:

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 TrainingAlso: Plasticity Based Adaptive Cognitive Remediation (PACR)Plasticity Based Adaptive Cognitive Remediation (PACR)	Behavioural	Cognitive Training

Primary outcome

Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention)
Time frame: 6-month follow-up
We presented change scores (6-month scores minus baseline scores) outcomes of 10 measures of neurocognitive measures (together with ranges): the Wechsler Memory Scale (WMS-IV) Paired Associates immediate and delayed memory (range: 1-19), Rey Auditory Verbal Learning Test (RAVLT) total score (range: 0-100) and delayed score (range: 0-20), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span (range: 0-48), Wechsler Adult Intelligence Scale (WAIS-IV) Letter Number Sequencing (range: 1-19), Auditory Consonant Trigrams (ACT) raw score (range: 0-60), Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition (range: 1-19), and the Brief Visual Memory Test revised (BVMT-R) total T score and Delayed T score (range: 20-80). Higher scores mean better cognitive functioning outcomes.

1 secondary outcome

Social and Occupational Functioning and Quality of Life Scores at 6 Months
Time frame: 6 month follow-up

Results and safety

Results posted to the registry on 5 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Training	25	23

Primary outcome: Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention)

Time frame: 6-month follow-up. Mean (Full Range). Unit: score on a scale

Measure	Treatment n = 7
WMS-IV Paired Associates Scaled score	2.29 (-1 to 6)
WMS-IV Paired Associates Delayed Scaled score	2.29 (0 to 6)
RAVLT Total raw score	0.71 (-4 to 7)
RAVLT Delayed raw score	0.14 (-3 to 3)
WMS-IV Digit Span Scaled score	2.43 (0 to 4)
WMS-IV Letter Number Sequencing scaled score	0.286 (-1 to 2)
ACT Raw score	10.57 (0 to 30)
D-KEFS Stroop Inhibition Standard score	2.71 (0 to 9)

Population analysed: Challenges in recruitment/retention led us to redesign the study as an open trial and the limitation is that there is a small number of subjects who completed the study.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive Training	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cognitive Impairment

RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
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Not yet recruitingObservational study
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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.

Karen H Seal, MD principal investigator

San Francisco VA Medical Center

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 in people with Cognitive Impairment, run by Karen Seal 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 14 inclusion and 6 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: finished, as of the sponsor's last update on 23 Dec 2019. 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?

Yes. Results are posted in the registry (first posted 5 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01087775.

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 23 Dec 2019.