Cognition DisordersCROVCDNCT01040858
Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder
A study testing Cognitive Strategy Training in people with Cognition Disorders, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
The number of OEF/OIF veterans seeking care and rehabilitation services within the VA Health Care System is increasing rapidly. The cognitive effects of MTBI are clinically significant and can adversely affect a veteran's ability to reintegrate into civilian life, return to duty, succeed in competitive employment, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognition Disorders
- What is being tested?
- Cognitive Strategy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2011to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OEF/OIF veterans enrolled at a participating VA who are able to provide informed consent; and
- As part of standard VA clinical care, have screened positive for MTBI and complain of cognitive impairment.
Who cannot join
- Current substance use disorder with less than 30 days abstinence;
- History of a primary psychotic disorder; and
- Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group or benefit from compensatory strategies.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Medical Center, Boise
Boise, Idaho, 83702
VA Medical Center, Portland
Portland, Oregon, 97201
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
About this study
Official title: Cognitive Rehabilitation of OIF/OEF Veterans With Cognitive Disorder
The number of OEF/OIF veterans seeking care and rehabilitation services within the VA Health Care System is increasing rapidly. The cognitive effects of MTBI are clinically significant and can adversely affect a veteran's ability to reintegrate into civilian life, return to duty, succeed in competitive employment, or function independently. The primary product of the proposed study would be an empirically validated, manualized, cognitive rehabilitation intervention for OIF/OIF veterans with cognitive disorders. The group treatment modality has the virtue of efficiency and a manualized treatment approach would allow wide-ranging application throughout the VHA system. As such, the proposed study is likely to have a significant effect on the quality and effectiveness of rehabilitative services being offered to our returning soldiers with combat-related MTBI and cognitive impairment.
Read the detailed description
As a result of the current military operations in Afghanistan (Operation Enduring Freedom; OEF) and Iraq (Operation Iraqi Freedom; OIF), the Department of Veterans Affairs (VA) is providing health care for increasing numbers of veterans who have experienced mild traumatic brain injury (MTBI) or concussion, many of whom complain of cognitive impairment. MTBI is the most common combat-related injury and can occur with or without direct impact, obvious external injuries, or loss of consciousness. Currently, cognitive rehabilitation for MTBI typically includes training in compensatory strategies that help patients develop internal strategies (e.g., visual imagery) and utilize external aides (e.g., memory notebooks, calendars/organizers, timers) to compensate for cognitive deficits. Initial data from our unfunded cognitive rehabilitation pilot study are encouraging and indicate post-treatment improvement on multiple outcome measures. However, to date, no published studies have evaluated the efficacy of specific cognitive rehabilitation interventions with OEF/OIF veterans who have experienced combat-related MTBI. The primary objective of this study, therefore, is to evaluate the efficacy of a manualized, 10-week, Compensatory Strategy Training (CST) intervention for OEF/OIF veterans with cognitive disorder resulting from the aftereffects of combat-related mild traumatic brain injury. The specific goals are: 1) to determine the efficacy of cognitive rehabilitation group treatment; and 2) to determine the treatment factors and patient characteristics that are associated with improved functional outcomes. The overall goal is to develop an evidence-based, manualized, group treatment that can be readily implemented in VHA treatment settings. The study design makes use of the convergent availability of resources available at the four participating VAs in Portland Oregon, Puget Sound Washington, San Diego California, and Boise Idaho. The study will recruit a total of 280 OEF/OIF veterans enrolled for medical services at these VAs. In a randomized controlled trial, we will compare two groups: eligible participants will be randomly assigned to either the Cognitive Strategy Training (CST) group or Usual Care (UC) group. Participants in the CST group will receive the CST intervention during their participation in the study, which will consist of weekly 120-minute group sessions for 10 weeks as guided by the CST Treatment Manual. UC participants will continue to receive usual care (i.e., their regular medical, psychiatric, and psychotherapeutic care; no CST intervention) during their participation, but will be offered CST after the end of the study. Both groups will undergo assessments at baseline, 5 weeks (midway through CST),10 weeks (immediately following the end of CST), and 15 weeks (5 weeks after CST is completed). These assessments will include a brief cognitive assessment battery and a battery of questionnaires and paper-pencil tests designed to assess current psychological and cognitive symptom severity, utility of compensatory strategies, self-efficacy, adaptive functioning, ability to reliably manage personal affairs, substance use, quality of life, and treatment satisfaction ratings. During their study participation, all participants will continue to receive their regular medical, psychiatric, and psychotherapeutic care.
- Conditions
- Cognition Disorders
- Being tested
- Cognitive Strategy Training, Placebo comparison group
- Keywords
- cognitive strategy intervention, cognitive disorders
- Medical subject headings
- Cognition Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Strategy TrainingBehavioural
Cognitive Strategy Training will consist of weekly 120-minute group sessions for 10 weeks.
Placebo comparison groupOther
Participants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Strategies Training | Experimental | Participants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study). Cognitive Strategies training consisted of interactive didactic presentations, in-class discussions, and activities that introduced participants to a variety of cognitive strategies and external aids. Receives: Behavioral: Cognitive Strategy Training |
| Placebo comparison group | Placebo comparator | Participants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study). Receives: Other: Placebo comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version
A self-report measure of severity of attention and organizational problems. It measures the sum of severity ratings on a scale from 0 (never) to 4 (very often). The total score ranges from 0 to 64.
Measured: Week 10
Secondary outcomes (11)
Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &
A 16-item self-report severity measure of prospective and retrospective memory problems relevant to everyday life. The measure reports the sum of severity ratings on a scale from 1 (never) to 5 (very often). The PRMQ total score ranges from 16 to 80.
Measured: Week 10
The Neurobehavioral Symptom Inventory
A post-concussive symptom measure. The total score on the measure is the sum of severity ratings for 22 symptoms on a scale from 0 (none) to 4 (very severe). NSI total score ranges from 0 to 88.
Measured: Week 10
Memory Compensation Questionnaire
The MCQ is a 44-item self-report questionnaire that rates the extent to which patients use various strategies to improve memory performance relevant to daily living. The MCQ measures the sum of memory strategies used on a scale from 0 (never) to 4 (always). The total score ranges from 0 to 176.
Measured: Week 10
Hopkins Verbal Memory Test-Revised
Verbal list learning and delayed recall. Total recall T-score was used for the analyses. Total recall T-score ranges from 13 (severely impaired) to 86 (very superior).
Measured: Week 10
Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest
A measure of attention and working memory. Total score was used, and it ranges from 0 to 48, with higher scores indicating greater attentional capacity.
Measured: Week 10
Delis-Kaplan Executive Function System, Trails Subtest
A visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Scaled score for Condition 4 was used, and possible scores ranges from 0 to 20 with higher scores indicating better outcome.
Measured: Week 10
Delis-Kaplan Executive Function System, Verbal Fluency Subtest
A measure of verbal fluency, generativity, and processing speed. A scaled score of Letter Fluency portion of the test was used. The scores ranged from 0 to 20 with higher scores indicating better outcomes.
Measured: Week 10
PTSD Checklist-Military Version
A PTSD symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severit ratings for 17 symptoms on a scale from 1 (not at all) to 5 (extremely). PCL-M total score ranges from 17 to 85.
Measured: Week 10
Beck Depression Inventory, Second Edition
A depression symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severity ratings for 21 symptoms on a scale from 0 (none) to 3 (severe). BDI total score ranges from 0 to 63.
Measured: Week 10
Severity of Dependence Scale
A brief substance dependence measure. It measures the sum of severity ratings for 5 symptoms on a scale from 0 (never) to 3 (always). The total score ranges from 0 15.
Measured: Week 10
Satisfaction With Life Scale
A brief measure of global life satisfaction. It measures the sum of satisfaction ratings for 5 items on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 5 to 35 with higher scores indicating greater satifaction.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionSep 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognition 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
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel M Storzbach, PhD, Principal investigator, VA Medical Center, Portland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040858
- Sponsor's protocol ID
- D7217-R
- Other IDs
- IRB#2277
- Acronym
- CROVCD
- Status last verified
- Jan 2015
- First submitted
- 28 Dec 2009
- Last updated
- 26 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pagulayan KF, O'Neil M, Williams RM, Turner AP, Golshan S, Roost MS, Laman-Maharg B, Huckans M, Storzbach D, Twamley EW. Mental Health Does Not Moderate Compensatory Cognitive Training Efficacy for Veterans With a History of Mild Traumatic Brain Injury. Arch Phys Med Rehabil. 2017 Sep;98(9):1893-1896.e2. doi: 10.1016/j.apmr.2017.04.009. Epub 2017 May 5.
PubMed 28483653
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation of OIF/OEF Veterans With Cognitive Disorder
- ClinicalTrials.gov ID
- NCT01040858
- Acronym / sponsor ID
- CROVCD / D7217-R
- Conditions
- Cognition Disorders
- Keywords
- cognitive strategy intervention, cognitive disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Dec 2009 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of OEF/OIF veterans seeking care and rehabilitation services within the VA Health Care System is increasing rapidly. The cognitive effects of MTBI are clinically significant and can adversely affect a veteran's ability to reintegrate into civilian life, return to duty, succeed in competitive employment, or function independently. The primary product of the proposed study would be an empirically validated, manualized, cognitive rehabilitation intervention for OIF/OIF veterans with cognitive disorders. The group treatment modality has the virtue of efficiency and a manualized treatment approach would allow wide-ranging application throughout the VHA system. As such, the proposed study is likely to have a significant effect on the quality and effectiveness of rehabilitative services being offered to our returning soldiers with combat-related MTBI and cognitive impairment.
Detailed description
As a result of the current military operations in Afghanistan (Operation Enduring Freedom; OEF) and Iraq (Operation Iraqi Freedom; OIF), the Department of Veterans Affairs (VA) is providing health care for increasing numbers of veterans who have experienced mild traumatic brain injury (MTBI) or concussion, many of whom complain of cognitive impairment. MTBI is the most common combat-related injury and can occur with or without direct impact, obvious external injuries, or loss of consciousness. Currently, cognitive rehabilitation for MTBI typically includes training in compensatory strategies that help patients develop internal strategies (e.g., visual imagery) and utilize external aides (e.g., memory notebooks, calendars/organizers, timers) to compensate for cognitive deficits. Initial data from our unfunded cognitive rehabilitation pilot study are encouraging and indicate post-treatment improvement on multiple outcome measures. However, to date, no published studies have evaluated the efficacy of specific cognitive rehabilitation interventions with OEF/OIF veterans who have experienced combat-related MTBI. The primary objective of this study, therefore, is to evaluate the efficacy of a manualized, 10-week, Compensatory Strategy Training (CST) intervention for OEF/OIF veterans with cognitive disorder resulting from the aftereffects of combat-related mild traumatic brain injury. The specific goals are: 1) to determine the efficacy of cognitive rehabilitation group treatment; and 2) to determine the treatment factors and patient characteristics that are associated with improved functional outcomes. The overall goal is to develop an evidence-based, manualized, group treatment that can be readily implemented in VHA treatment settings. The study design makes use of the convergent availability of resources available at the four participating VAs in Portland Oregon, Puget Sound Washington, San Diego California, and Boise Idaho. The study will recruit a total of 280 OEF/OIF veterans enrolled for medical services at these VAs. In a randomized controlled trial, we will compare two groups: eligible participants will be randomly assigned to either the Cognitive Strategy Training (CST) group or Usual Care (UC) group. Participants in the CST group will receive the CST intervention during their participation in the study, which will consist of weekly 120-minute group sessions for 10 weeks as guided by the CST Treatment Manual. UC participants will continue to receive usual care (i.e., their regular medical, psychiatric, and psychotherapeutic care; no CST intervention) during their participation, but will be offered CST after the end of the study. Both groups will undergo assessments at baseline, 5 weeks (midway through CST),10 weeks (immediately following the end of CST), and 15 weeks (5 weeks after CST is completed). These assessments will include a brief cognitive assessment battery and a battery of questionnaires and paper-pencil tests designed to assess current psychological and cognitive symptom severity, utility of compensatory strategies, self-efficacy, adaptive functioning, ability to reliably manage personal affairs, substance use, quality of life, and treatment satisfaction ratings. During their study participation, all participants will continue to receive their regular medical, psychiatric, and psychotherapeutic care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Strategies Training | Experimental | Behavioral: Cognitive Strategy TrainingParticipants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study). Cognitive Strategies training consisted of interactive didactic presentations, in-class discussions, and activities that introduced participants to a variety of cognitive strategies and external aids. |
| Placebo comparison group | Placebo comparator | Other: Placebo comparison groupParticipants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OEF/OIF veterans enrolled at a participating VA who are able to provide informed consent; and
- As part of standard VA clinical care, have screened positive for MTBI and complain of cognitive impairment.
Key exclusion criteria (3 listed)
- Current substance use disorder with less than 30 days abstinence;
- History of a primary psychotic disorder; and
- Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group or benefit from compensatory strategies.
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 Strategy TrainingCognitive Strategy Training will consist of weekly 120-minute group sessions for 10 weeks. | Behavioural | Cognitive Strategies Training |
| Placebo comparison groupParticipants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study). | Other | Placebo comparison group |
Primary outcome
Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version
Time frame: Week 10
A self-report measure of severity of attention and organizational problems. It measures the sum of severity ratings on a scale from 0 (never) to 4 (very often). The total score ranges from 0 to 64.
11 secondary outcomes
Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &
Time frame: Week 10
The Neurobehavioral Symptom Inventory
Time frame: Week 10
Memory Compensation Questionnaire
Time frame: Week 10
Hopkins Verbal Memory Test-Revised
Time frame: Week 10
Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest
Time frame: Week 10
Delis-Kaplan Executive Function System, Trails Subtest
Time frame: Week 10
Delis-Kaplan Executive Function System, Verbal Fluency Subtest
Time frame: Week 10
PTSD Checklist-Military Version
Time frame: Week 10
Beck Depression Inventory, Second Edition
Time frame: Week 10
Severity of Dependence Scale
Time frame: Week 10
Satisfaction With Life Scale
Time frame: Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28483653Pagulayan KF, O'Neil M, Williams RM, Turner AP, Golshan S, Roost MS, Laman-Maharg B, Huckans M, Storzbach D, Twamley EW. Mental Health Does Not Moderate Compensatory Cognitive Training Efficacy for Veterans With a History of Mild Traumatic Brain Injury. Arch Phys Med Rehabil. 2017 Sep;98(9):1893-1896.e2. doi: 10.1016/j.apmr.2017.04.009. Epub 2017 May 5.
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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.
Daniel M Storzbach, PhD principal investigator
VA Medical Center, Portland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Strategy Training in people with Cognition Disorders, run by US Department of Veterans Affairs at 4 sites 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 2 inclusion and 3 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 26 Jan 2015). 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?
Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version (time frame: Week 10). 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 NCT01040858, which also lists 1 linked publication.
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 26 Jan 2015.