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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 ( US Department of Veterans Affairs )

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
Enrollment 128
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Strategies Training Placebo Comparison Group
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 59 69
Completed 50 69
Not Completed 9 0
Arm/Group Title Cognitive Strategies Group Placebo Comparison Group Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 50 69 119
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 69 participants 119 participants
34.8  (7) 35.4  (8) 34.8  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 69 participants 119 participants
Female
3
   6.0%
3
   4.3%
6
   5.0%
Male
47
  94.0%
66
  95.7%
113
  95.0%
The Neurobehavioral Symptom Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
45.04  (16.32) 44.8  (14.5) 44.90  (14.01)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
57.2  (8) 55.4  (10) 56.1  (9.5)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
37.8  (9) 37.0  (10) 37.3  (9.7)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
119.8  (24) 118.5  (7) 119.03  (24.7)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
97.02  (8.75) 99.70  (8.3) 98.56  (8.6)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
41.6  (11.2) 40.48  (12.2) 40.95  (11.7)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
25.76  (5.42) 27.10  (6.41) 26.53  (6.0)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
9.3  (3) 9.84  (2) 9.31  (3)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
9.78  (3.3) 10.18  (3.7) 10.01  (3.5)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
57.50  (14.5) 58.94  (14.5) 58.31  (14.4)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
24.9  (12.2) 25.3  (12.6) 25.11  (12.34)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
1.04  (2.3) 0.46  (1.2) 0.70  (1.78)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 69 participants 119 participants
16.30  (7.5) 16.73  (7.1) 16.6  (7.2)
[1]
Measure Description: 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.
1.Primary Outcome
Title Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo Comparison Group
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
33.58  (9.52) 36.35  (10.23)
2.Secondary Outcome
Title Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo Comparison Group
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.56  (10) 55.20  (12)
3.Secondary Outcome
Title The Neurobehavioral Symptom Inventory
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
40.89  (17.7) 43.52  (17.69)
4.Secondary Outcome
Title Memory Compensation Questionnaire
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
123.08  (26.2) 119.52  (28.33)
5.Secondary Outcome
Title Hopkins Verbal Memory Test-Revised
Hide Description 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).
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.50  (12.97) 44.75  (12.2)
6.Secondary Outcome
Title Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.39  (5.76) 28.58  (5.79)
7.Secondary Outcome
Title Delis-Kaplan Executive Function System, Trails Subtest
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.89  (2.9) 10.38  (2.24)
8.Secondary Outcome
Title Delis-Kaplan Executive Function System, Verbal Fluency Subtest
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.31  (2.72) 10.63  (3.10)
9.Secondary Outcome
Title PTSD Checklist-Military Version
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.22  (16.42) 57.18  (17.0)
10.Secondary Outcome
Title Beck Depression Inventory, Second Edition
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.53  (14) 23.75  (14.79)
11.Secondary Outcome
Title Severity of Dependence Scale
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.67  (2.01) 0.73  (2.1)
12.Secondary Outcome
Title Satisfaction With Life Scale
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
Arm/Group Title Cognitive Strategies Training Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 36 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.44  (8.5) 17.69  (7.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description 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 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.
All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/69 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/69 (0.00%) 
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
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
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