Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder (CROVCD)
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| First Received Date ICMJE | December 28, 2009 | ||||||||
| Last Updated Date | January 15, 2013 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version [ Time Frame: Weeks 1, 5, 10, 15 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01040858 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder | ||||||||
| Official Title ICMJE | Cognitive Rehabilitation of OIF/OEF Veterans With Cognitive Disorder | ||||||||
| Brief 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 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Cognition Disorders | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 280 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01040858 | ||||||||
| Other Study ID Numbers ICMJE | D7217-R, IRB#2277 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Department of Veterans Affairs | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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