Clinical trial NCT01040858: Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder
Official title: Cognitive Rehabilitation of OIF/OEF Veterans With Cognitive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition Disorders
Keywords: cognitive strategy intervention
cognitive disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-12-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version
timeFrame: Week 10
Secondary outcomes:
measure: Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &
timeFrame: Week 10
measure: The Neurobehavioral Symptom Inventory
timeFrame: Week 10
measure: Memory Compensation Questionnaire
timeFrame: Week 10
measure: Hopkins Verbal Memory Test-Revised
timeFrame: Week 10
measure: Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest
timeFrame: Week 10
measure: Delis-Kaplan Executive Function System, Trails Subtest
timeFrame: Week 10
measure: Delis-Kaplan Executive Function System, Verbal Fluency Subtest
timeFrame: Week 10
measure: PTSD Checklist-Military Version
timeFrame: Week 10
measure: Beck Depression Inventory, Second Edition
timeFrame: Week 10
measure: Severity of Dependence Scale
timeFrame: Week 10
measure: Satisfaction With Life Scale
timeFrame: Week 10
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
city: Boise
country: United States
facility: VA Medical Center, Boise
state: Idaho
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
city: Seattle
country: United States
facility: VA Puget Sound Health Care System, Seattle
state: Washington
Study officials:
affiliation: VA Medical Center, Portland
name: Daniel M Storzbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.