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

Cognitive Rehabilitation of OIF/OEF Veterans With Cognitive Disorder

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01040858

Acronym

CROVCD

Enrollment

128

Registered

2009-12-30

Start date

2011-05-31

Completion date

2013-09-30

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition Disorders

Keywords

cognitive strategy intervention, cognitive disorders

Brief summary

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.

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.

Interventions

BEHAVIORALCognitive Strategy Training

Cognitive Strategy Training will consist of weekly 120-minute group sessions for 10 weeks.

OTHERPlacebo 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version	Week 10	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

Measure	Time frame	Description
The Neurobehavioral Symptom Inventory	Week 10	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	Week 10	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	Week 10	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	Week 10	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	Week 10	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.
Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &	Week 10	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.
PTSD Checklist-Military Version	Week 10	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	Week 10	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	Week 10	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	Week 10	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.
Delis-Kaplan Executive Function System, Verbal Fluency Subtest	Week 10	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	50
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.	69
Total	119

Baseline characteristics

Characteristic	Cognitive Strategies Group	Placebo Comparison Group	Total
Age, Continuous	34.8 years STANDARD_DEVIATION 7	35.4 years STANDARD_DEVIATION 8	34.8 years STANDARD_DEVIATION 7.9
Beck Depression Inventory, Second Edition	24.9 units on a scale STANDARD_DEVIATION 12.2	25.3 units on a scale STANDARD_DEVIATION 12.6	25.11 units on a scale STANDARD_DEVIATION 12.34
Delis-Kaplan Executive Function System, Letter Fluency Subtest	9.78 units on a scale STANDARD_DEVIATION 3.3	10.18 units on a scale STANDARD_DEVIATION 3.7	10.01 units on a scale STANDARD_DEVIATION 3.5
Delis-Kaplan Executive Function System, Trails Subtest	9.3 units on a scale STANDARD_DEVIATION 3	9.84 units on a scale STANDARD_DEVIATION 2	9.31 units on a scale STANDARD_DEVIATION 3
Hopkins Verbal Memory Test-Revised	41.6 units on a scale STANDARD_DEVIATION 11.2	40.48 units on a scale STANDARD_DEVIATION 12.2	40.95 units on a scale STANDARD_DEVIATION 11.7
Memory Compensation Questionnaire	119.8 units on a scale STANDARD_DEVIATION 24	118.5 units on a scale STANDARD_DEVIATION 7	119.03 units on a scale STANDARD_DEVIATION 24.7
Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version	37.8 units on a scale STANDARD_DEVIATION 9	37.0 units on a scale STANDARD_DEVIATION 10	37.3 units on a scale STANDARD_DEVIATION 9.7
Prospective-Retrospective Memory Questionnaire	57.2 units on a scale STANDARD_DEVIATION 8	55.4 units on a scale STANDARD_DEVIATION 10	56.1 units on a scale STANDARD_DEVIATION 9.5
PTSD Checklist-Military Version	57.50 units on a scale STANDARD_DEVIATION 14.5	58.94 units on a scale STANDARD_DEVIATION 14.5	58.31 units on a scale STANDARD_DEVIATION 14.4
Satisfaction with Life Scale	16.30 units on a scale STANDARD_DEVIATION 7.5	16.73 units on a scale STANDARD_DEVIATION 7.1	16.6 units on a scale STANDARD_DEVIATION 7.2
Severity of Dependence Scale	1.04 units on a scale STANDARD_DEVIATION 2.3	0.46 units on a scale STANDARD_DEVIATION 1.2	0.70 units on a scale STANDARD_DEVIATION 1.78
Sex: Female, Male Female	3 Participants	3 Participants	6 Participants
Sex: Female, Male Male	47 Participants	66 Participants	113 Participants
The Neurobehavioral Symptom Inventory	45.04 units on a scale STANDARD_DEVIATION 16.32	44.8 units on a scale STANDARD_DEVIATION 14.5	44.90 units on a scale STANDARD_DEVIATION 14.01
The Wide Range Achievement Test-IV	97.02 units on a scale STANDARD_DEVIATION 8.75	99.70 units on a scale STANDARD_DEVIATION 8.3	98.56 units on a scale STANDARD_DEVIATION 8.6
Wechsler Adult Intelligence Scale-Digit Span	25.76 units on a scale STANDARD_DEVIATION 5.42	27.10 units on a scale STANDARD_DEVIATION 6.41	26.53 units on a scale STANDARD_DEVIATION 6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 50	0 / 69
serious Total, serious adverse events	0 / 50	0 / 69

Outcome results

Primary

Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version

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