N/A
N=128
Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder
Cognition Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01040858 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version — 33.58; 36.35 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Strategy Training (Behavioral); Placebo comparison group (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version |
33.58; 36.35 | — |
| SECONDARY Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, & |
49.56; 55.20 | — |
| SECONDARY The Neurobehavioral Symptom Inventory |
40.89; 43.52 | — |
| SECONDARY Memory Compensation Questionnaire |
123.08; 119.52 | — |
| SECONDARY Hopkins Verbal Memory Test-Revised |
50.50; 44.75 | — |
| SECONDARY Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest |
28.39; 28.58 | — |
| SECONDARY Delis-Kaplan Executive Function System, Trails Subtest |
9.89; 10.38 | — |
| SECONDARY Delis-Kaplan Executive Function System, Verbal Fluency Subtest |
11.31; 10.63 | — |
| SECONDARY PTSD Checklist-Military Version |
53.22; 57.18 | — |
| SECONDARY Beck Depression Inventory, Second Edition |
20.53; 23.75 | — |
| SECONDARY Severity of Dependence Scale |
0.67; 0.73 | — |
| SECONDARY Satisfaction With Life Scale |
17.44; 17.69 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01040858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.