Trial Outcomes & Findings for Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder (NCT NCT01040858)
NCT ID: NCT01040858
Last Updated: 2015-01-26
Results Overview
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.
COMPLETED
NA
128 participants
Week 10
2015-01-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
69
|
|
Overall Study
COMPLETED
|
50
|
69
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Rehabilitation of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans With Cognitive Disorder
Baseline characteristics by cohort
| Measure |
Cognitive Strategies Group
n=50 Participants
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
n=69 Participants
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
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 7 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 8 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
The Neurobehavioral Symptom Inventory
|
45.04 units on a scale
STANDARD_DEVIATION 16.32 • n=5 Participants
|
44.8 units on a scale
STANDARD_DEVIATION 14.5 • n=7 Participants
|
44.90 units on a scale
STANDARD_DEVIATION 14.01 • n=5 Participants
|
|
Prospective-Retrospective Memory Questionnaire
|
57.2 units on a scale
STANDARD_DEVIATION 8 • n=5 Participants
|
55.4 units on a scale
STANDARD_DEVIATION 10 • n=7 Participants
|
56.1 units on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version
|
37.8 units on a scale
STANDARD_DEVIATION 9 • n=5 Participants
|
37.0 units on a scale
STANDARD_DEVIATION 10 • n=7 Participants
|
37.3 units on a scale
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Memory Compensation Questionnaire
|
119.8 units on a scale
STANDARD_DEVIATION 24 • n=5 Participants
|
118.5 units on a scale
STANDARD_DEVIATION 7 • n=7 Participants
|
119.03 units on a scale
STANDARD_DEVIATION 24.7 • n=5 Participants
|
|
The Wide Range Achievement Test-IV
|
97.02 units on a scale
STANDARD_DEVIATION 8.75 • n=5 Participants
|
99.70 units on a scale
STANDARD_DEVIATION 8.3 • n=7 Participants
|
98.56 units on a scale
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Hopkins Verbal Memory Test-Revised
|
41.6 units on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
40.48 units on a scale
STANDARD_DEVIATION 12.2 • n=7 Participants
|
40.95 units on a scale
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Wechsler Adult Intelligence Scale-Digit Span
|
25.76 units on a scale
STANDARD_DEVIATION 5.42 • n=5 Participants
|
27.10 units on a scale
STANDARD_DEVIATION 6.41 • n=7 Participants
|
26.53 units on a scale
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Delis-Kaplan Executive Function System, Trails Subtest
|
9.3 units on a scale
STANDARD_DEVIATION 3 • n=5 Participants
|
9.84 units on a scale
STANDARD_DEVIATION 2 • n=7 Participants
|
9.31 units on a scale
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Delis-Kaplan Executive Function System, Letter Fluency Subtest
|
9.78 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
10.18 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
10.01 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
PTSD Checklist-Military Version
|
57.50 units on a scale
STANDARD_DEVIATION 14.5 • n=5 Participants
|
58.94 units on a scale
STANDARD_DEVIATION 14.5 • n=7 Participants
|
58.31 units on a scale
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Beck Depression Inventory, Second Edition
|
24.9 units on a scale
STANDARD_DEVIATION 12.2 • n=5 Participants
|
25.3 units on a scale
STANDARD_DEVIATION 12.6 • n=7 Participants
|
25.11 units on a scale
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Severity of Dependence Scale
|
1.04 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
0.46 units on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
0.70 units on a scale
STANDARD_DEVIATION 1.78 • n=5 Participants
|
|
Satisfaction with Life Scale
|
16.30 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
16.73 units on a scale
STANDARD_DEVIATION 7.1 • n=7 Participants
|
16.6 units on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version
|
33.58 units on a scale
Standard Deviation 9.52
|
36.35 units on a scale
Standard Deviation 10.23
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &
|
49.56 units on a scale
Standard Deviation 10
|
55.20 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
The Neurobehavioral Symptom Inventory
|
40.89 units on a scale
Standard Deviation 17.7
|
43.52 units on a scale
Standard Deviation 17.69
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Memory Compensation Questionnaire
|
123.08 units on a scale
Standard Deviation 26.2
|
119.52 units on a scale
Standard Deviation 28.33
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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).
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Hopkins Verbal Memory Test-Revised
|
50.50 units on a scale
Standard Deviation 12.97
|
44.75 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest
|
28.39 units on a scale
Standard Deviation 5.76
|
28.58 units on a scale
Standard Deviation 5.79
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Delis-Kaplan Executive Function System, Trails Subtest
|
9.89 units on a scale
Standard Deviation 2.9
|
10.38 units on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Delis-Kaplan Executive Function System, Verbal Fluency Subtest
|
11.31 units on a scale
Standard Deviation 2.72
|
10.63 units on a scale
Standard Deviation 3.10
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
PTSD Checklist-Military Version
|
53.22 units on a scale
Standard Deviation 16.42
|
57.18 units on a scale
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Beck Depression Inventory, Second Edition
|
20.53 units on a scale
Standard Deviation 14
|
23.75 units on a scale
Standard Deviation 14.79
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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.
Outcome measures
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Severity of Dependence Scale
|
0.67 units on a scale
Standard Deviation 2.01
|
0.73 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week 10Population: The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.
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
| Measure |
Cognitive Strategies Training
n=36 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Satisfaction With Life Scale
|
17.44 units on a scale
Standard Deviation 8.5
|
17.69 units on a scale
Standard Deviation 7.8
|
Adverse Events
Arm 1
Arm 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place