Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder (CROVCD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01040858
First received: December 28, 2009
Last updated: January 14, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Cognition Disorders
Behavioral: Cognitive Strategy Training
Other: Placebo comparison group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation of OIF/OEF Veterans With Cognitive Disorder

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, & [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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 Neurobehavioral Symptom Inventory [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.

  • Memory Compensation Questionnaire [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.

  • Hopkins Verbal Memory Test-Revised [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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).

  • Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.

  • Delis-Kaplan Executive Function System, Trails Subtest [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.

  • Delis-Kaplan Executive Function System, Verbal Fluency Subtest [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.

  • PTSD Checklist-Military Version [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.

  • Beck Depression Inventory, Second Edition [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.

  • Severity of Dependence Scale [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.

  • Satisfaction With Life Scale [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.


Enrollment: 128
Study Start Date: May 2011
Study Completion Date: September 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Strategies Training
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.
Behavioral: Cognitive Strategy Training
Cognitive Strategy Training will consist of weekly 120-minute group sessions for 10 weeks.
Placebo Comparator: Placebo comparison group
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).
Other: Placebo comparison group
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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040858

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, Idaho
VA Medical Center, Boise
Boise, Idaho, United States, 83702
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel M Storzbach, PhD VA Medical Center, Portland
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01040858     History of Changes
Other Study ID Numbers: D7217-R, IRB#2277
Study First Received: December 28, 2009
Results First Received: November 7, 2014
Last Updated: January 14, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cognitive strategy intervention
cognitive disorders

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 26, 2015