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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Strategies Training

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). Cognitive Strategies training consisted of interactive didactic presentations, in-class discussions, and activities that introduced participants to a variety of cognitive strategies and external aids.

Group Type EXPERIMENTAL

Cognitive Strategy Training

Intervention Type BEHAVIORAL

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

Placebo 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).

Group Type PLACEBO_COMPARATOR

Placebo comparison group

Intervention Type OTHER

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).

Interventions

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Cognitive Strategy Training

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

Intervention Type BEHAVIORAL

Placebo 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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No