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View Clinical Trial (Medical Research Study)
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Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder - NCT01040858-83702 (Clinical Trial 463874)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy463874.aspx
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| City: |
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Boise |
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State:
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ID |
| Zip Code: |
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83702 |
| Conditions: |
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Cognition Disorders |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
1. OEF/OIF veterans enrolled at a participating VA who are able to provide informed
consent; and
2. As part of standard VA clinical care, have screened positive for MTBI and complain of
cognitive impairment.
Exclusion Criteria:
1. Current substance use disorder with less than 30 days abstinence;
2. History of a primary psychotic disorder; and
3. Auditory or visual impairments that would prevent ability to participate in the
cognitive rehabilitation group or benefit from compensatory strategies. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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