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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):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01040858
First received: December 28, 2009
Last updated: January 14, 2015
Last verified: January 2015
Results First Received: November 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cognition Disorders
Interventions: Behavioral: Cognitive Strategy Training
Other: Placebo comparison group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cognitive Strategies Training Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
Placebo Comparison Group Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.

Participant Flow:   Overall Study
    Cognitive Strategies Training   Placebo Comparison Group
STARTED   59   69 
COMPLETED   50   69 
NOT COMPLETED   9   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 128 subjects who consented to participate in the study, 9 participants who were randomized to the Cognitive Strategies Training, did not complete the training due to schedule conflict, etc. Thus, their data was not included in the final analysis.

Reporting Groups
  Description
Cognitive Strategies Group Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
Placebo Comparison Group Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
Total Total of all reporting groups

Baseline Measures
   Cognitive Strategies Group   Placebo Comparison Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   69   119 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.8  (7)   35.4  (8)   34.8  (7.9) 
Gender 
[Units: Participants]
     
Female   3   3   6 
Male   47   66   113 
The Neurobehavioral Symptom Inventory [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 45.04  (16.32)   44.8  (14.5)   44.90  (14.01) 
[1] 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.
Prospective-Retrospective Memory Questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 57.2  (8)   55.4  (10)   56.1  (9.5) 
[1] 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.
Multiple Sclerosis Neuropsychological Screening Questionnaire–Patient Version [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 37.8  (9)   37.0  (10)   37.3  (9.7) 
[1] 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.
Memory Compensation Questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 119.8  (24)   118.5  (7)   119.03  (24.7) 
[1] 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.
The Wide Range Achievement Test-IV [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 97.02  (8.75)   99.70  (8.3)   98.56  (8.6) 
[1] Reading subtest that provides an estimate of baseline cognitive ability. This assessment was administered only at baseline, and was not repeated. The total score ranges from 55 (lower cognitive ability) to 145 (higher cognitive ability).
Hopkins Verbal Memory Test–Revised [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 41.6  (11.2)   40.48  (12.2)   40.95  (11.7) 
[1] 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–Digit Span [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 25.76  (5.42)   27.10  (6.41)   26.53  (6.0) 
[1] 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 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 9.3  (3)   9.84  (2)   9.31  (3) 
[1] 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, Letter Fluency Subtest [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 9.78  (3.3)   10.18  (3.7)   10.01  (3.5) 
[1] 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 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 57.50  (14.5)   58.94  (14.5)   58.31  (14.4) 
[1] 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 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 24.9  (12.2)   25.3  (12.6)   25.11  (12.34) 
[1] 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 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.04  (2.3)   0.46  (1.2)   0.70  (1.78) 
[1] 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 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 16.30  (7.5)   16.73  (7.1)   16.6  (7.2) 
[1] 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.


  Outcome Measures
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1.  Primary:   Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version   [ Time Frame: Week 10 ]

2.  Secondary:   Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &   [ Time Frame: Week 10 ]

3.  Secondary:   The Neurobehavioral Symptom Inventory   [ Time Frame: Week 10 ]

4.  Secondary:   Memory Compensation Questionnaire   [ Time Frame: Week 10 ]

5.  Secondary:   Hopkins Verbal Memory Test-Revised   [ Time Frame: Week 10 ]

6.  Secondary:   Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest   [ Time Frame: Week 10 ]

7.  Secondary:   Delis-Kaplan Executive Function System, Trails Subtest   [ Time Frame: Week 10 ]

8.  Secondary:   Delis-Kaplan Executive Function System, Verbal Fluency Subtest   [ Time Frame: Week 10 ]

9.  Secondary:   PTSD Checklist-Military Version   [ Time Frame: Week 10 ]

10.  Secondary:   Beck Depression Inventory, Second Edition   [ Time Frame: Week 10 ]

11.  Secondary:   Severity of Dependence Scale   [ Time Frame: Week 10 ]

12.  Secondary:   Satisfaction With Life Scale   [ Time Frame: Week 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Daniel Storzbach
Organization: Portland VA Healthcare System
phone: 503-220-8262 ext 56497
e-mail: Daniel.Storzbach@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01040858     History of Changes
Other Study ID Numbers: D7217-R
IRB#2277 ( Other Identifier: Portland VA Medical Center )
Study First Received: December 28, 2009
Results First Received: November 7, 2014
Last Updated: January 14, 2015
Health Authority: United States: Federal Government