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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#2277 | Other Identifier | Portland VA Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Strategy Training | Behavioral | Cognitive Strategy Training will consist of weekly 120-minute group sessions for 10 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel M Storzbach, PhD | VA Medical Center, Portland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego | San Diego | California | 92161 | United States | ||
| VA Medical Center, Boise |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28483653 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Strategies Training | Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks. |
| FG001 | Placebo Comparison Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo comparison group | Other | 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). |
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| 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. |
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 10 |
| Boise |
| Idaho |
| 83702 |
| United States |
| VA Medical Center, Portland | Portland | Oregon | 97201 | United States |
| VA Puget Sound Health Care System, Seattle | Seattle | Washington | 98108 | United States |
Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study. |
| COMPLETED |
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| NOT COMPLETED |
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Of the 128 subjects who consented to participate in the study, 9 participants who were randomized to the Cognitive Strategies Training, did not complete the training due to schedule conflict, etc. Thus, their data was not included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Strategies Group | Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks. |
| BG001 | Placebo Comparison Group | Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Prospective-Retrospective Memory Questionnaire | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| The Wide Range Achievement Test-IV | Reading subtest that provides an estimate of baseline cognitive ability. This assessment was administered only at baseline, and was not repeated. The total score ranges from 55 (lower cognitive ability) to 145 (higher cognitive ability). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Wechsler Adult Intelligence Scale-Digit Span | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Delis-Kaplan Executive Function System, Letter 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
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| 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. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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). | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| Secondary | 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. | The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks. | 0 | 50 | 0 | 50 | ||
| EG001 | Arm 2 | Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study. | 0 | 69 | 0 | 69 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Storzbach | Portland VA Healthcare System | 503-220-8262 | 56497 | Daniel.Storzbach@va.gov |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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