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

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ClinicalTrials.gov Identifier: NCT01040858
Recruitment Status : Completed
First Posted : December 30, 2009
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cognition Disorders
Interventions: Behavioral: Cognitive Strategy Training
Other: Placebo comparison group

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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) 
Prospective-Retrospective Memory Questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 57.2  (8)   55.4  (10)   56.1  (9.5) 
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) 
Memory Compensation Questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 119.8  (24)   118.5  (7)   119.03  (24.7) 
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) 
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) 
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) 
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) 
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) 
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) 
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) 
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) 
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) 


  Outcome Measures

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

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 )
First Submitted: December 28, 2009
First Posted: December 30, 2009
Results First Submitted: November 7, 2014
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015