11

Multi-Modal or Comprehensive
Cognitive Rehabilitation Therapy

OVERVIEW

In cases where an individual has sustained multiple cognitive or behavioral impairments, as is often the case with traumatic brain injury (TBI), a comprehensive treatment program may be ideal. In comprehensive cognitive rehabilitation therapy (CRT) programs (also called multi-modal or holistic), a team of therapists and other rehabilitation providers work together to ensure the most appropriate timing, delivery, and content of therapy for an individual. These treatment programs may occur during inpatient stays, or extend through outpatient programs. In this chapter, the committee reviews the studies on multi-modal/comprehensive CRT, divided by phase of recovery. Controlled studies are divided by comparator arm within these sections, and the committee’s conclusions are included at the end of each section.

The committee identified and reviewed six randomized controlled trials (RCTs) of multi-modal or comprehensive (holistic) CRT (Cicerone et al. 2008; Ruff and Niemann 1990; Salazar et al. 2000; Tiersky et al. 2005; Vanderploeg et al. 2008; Zhu et al. 2007). These trials were heterogeneous. Only one trial targeted mild TBI; three focused on the subacute phase while the other three focused on the chronic phase of recovery. Four of the six RCTs had some form of CRT in both trial arms.

Eight additional studies wtraining with traumatically brain-injured clients. Brainere identified as nonrandomized parallel group controlled studies. Three of the eight included CRT in the comparator group. One study was in the subacute phase, seven were in the chronic



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11 Multi-Modal or Comprehensive Cognitive Rehabilitation Therapy OVERVIEW In cases where an individual has sustained multiple cognitive or be- havioral impairments, as is often the case with traumatic brain injury (TBI), a comprehensive treatment program may be ideal. In comprehensive cognitive rehabilitation therapy (CRT) programs (also called multi-modal or holistic), a team of therapists and other rehabilitation providers work together to ensure the most appropriate timing, delivery, and content of therapy for an individual. These treatment programs may occur during inpatient stays, or extend through outpatient programs. In this chapter, the committee reviews the studies on multi-modal/comprehensive CRT, divided by phase of recovery. Controlled studies are divided by comparator arm within these sections, and the committee’s conclusions are included at the end of each section. The committee identified and reviewed six randomized controlled tri- als (RCTs) of multi-modal or comprehensive (holistic) CRT (Cicerone et al. 2008; Ruff and Niemann 1990; Salazar et al. 2000; Tiersky et al. 2005; Vanderploeg et al. 2008; Zhu et al. 2007). These trials were heterogeneous. Only one trial targeted mild TBI; three focused on the subacute phase while the other three focused on the chronic phase of recovery. Four of the six RCTs had some form of CRT in both trial arms. Eight additional studies were identified as nonrandomized parallel group controlled studies. Three of the eight included CRT in the compara- tor group. One study was in the subacute phase, seven were in the chronic 213

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214 COGNITIVE REHABILITATION THERAPY FOR TBI phase, two included both subacute and chronic patients, and one did not report the time since injury. None of the studies was identified as exclusively or predominantly enrolling mild TBI patients. Studies ranged in sample size from 36 to 205 and were equally split between inpatient and outpatient settings. Seven studies were pre-post, single group design without any com- parison or control group. However, there was a broad range in the quality of the design, execution, and reporting of the studies. Table 11-1 (at the end of the chapter) presents a summary of all included studies in this review. SUBACUTE PHASE OF RECOVERY The committee reviewed three RCTs (Salazar et al. 2000; Vanderploeg et al. 2008; Zhu et al. 2007) of multi-modal/comprehensive CRT in patients in the subacute phase of moderate-severe TBI; one nonrandomized, paral- lel group study (Bowen et al. 1999) of multi-modal/comprehensive CRT included patients in the subacute phase of recovery from mild, moderate, and severe TBI. All four studies enrolled patients within 6 months of their injury. Most significantly, all three RCTs had some element of CRT in their comparator arms. Thus, the goal of these studies was to determine whether there was a benefit of one form or level of intensity of CRT relative to an- other, early after injury. These studies were not designed to assess efficacy relative to no treatment or relative to an inert or minimal control condition, such as a waitlist group. Table 11-2 presents all subacute phase studies by design and treatment comparator. Comparator Group: Non-CRT Content Bowen et al. (1999), a single, nonrandomized, parallel group study, included 104 patients in the subacute phase with TBI severity ranging from mild to severe. The aim of the study was to evaluate outcomes of services provided by a community-based, interdisciplinary team of specialists— clinical psychologist, occupational therapist, family support nurse—all TABLE 11-2 Studies in the Subacute Phase of Recovery Treatment Comparator Study Design No Treatment Non-CRT Other CRT Salazar et al. 2000 RCT X Vanderploeg et al. 2008 RCT X Zhu et al. 2007 RCT X Bowen et al. 1999 Parallel X

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215 MULTI-MODAL OR COMPREHENSIVE CRT supported by a clinical coordinator. Treatment took place either before discharge from an inpatient hospital stay (mean 5 days postinjury) or after discharge from an inpatient hospital stay (mean 37 days postinjury). Overall, the median contact time with team members was relatively small— fewer than 15 hours for the early group and fewer than 10 hours for the late group. A third group was offered no specialized interdisciplinary team services. All three arms continued to receive existing services or care as usual. Because of the nature of the program, individual-level randomization was deemed infeasible; randomization occurred by 3-month blocks of time and was rotated across the two hospital sites involved in the study. The study included assessment of a broad range of outcomes (e.g., social, cog- nitive, behavioral, employment, handicap, functional limitations) at 6 and 12 months postinjury. The extent of contact with different team members is well described in the study. There were problems with protocol compli- ance, in the form of crossovers from original group assignment, which may have been systematic. Using the significance of 0.01 in light of the multiple outcomes, and adjusting for coma duration and age (which differed across the groups), essentially there were no differences in assessed outcomes. Comparator Group: Other CRT Content Salazar et al. (2000)1 conducted an RCT involving 120 active-duty military personnel who had recovered sufficiently from a recent moderate- severe closed head injury (within 3 months of randomization) to participate in a cognitive rehabilitation program or safely return home with a care- giver. All were oriented and had a Rancho Los Amigos cognitive level 7. Most had headaches. About one-third of the participants were described as having aggressive behavior or major depression, although few were taking psychotropic medications. Participants were randomly assigned to a comprehensive, 8-week in-hospital cognitive rehabilitation program or, after receiving some inpatient memory training, were discharged to home for a program of education and counseling via weekly telephone calls from a psychiatric nurse. During the telephone calls, which were described as lasting 30 minutes, nurses inquired about the week’s events, offered support and advice in addressing problems, and checked on use of memory aids. Of the 67 participants assigned to the in-hospital program, 60 completed the program; 47 of the 53 assigned to the home program completed the trial. Six patients assigned to home rehabilitation required supplemental therapy. At 1 year posttreatment, more than 90 percent of the participants in both groups returned to work, the primary outcome measure (group difference 1 The committee reviewed Salazar et al. 2000, with Braverman et al. 1999, and Warden et al. 2000.

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216 COGNITIVE REHABILITATION THERAPY FOR TBI was 4 percent [95 percent confidence interval, 5 to 14 percent]). The pro- portion of participants between groups who were fit for duty was also not statistically different: 73 percent of the inpatient arm versus 66 percent of the home rehabilitation program. A range of neuropsychological tests, as well as behavior, social adjustment (belligerence, social irresponsibility, an- tisocial behavior, social withdrawal, and apathy), and mood measures did not differ across groups at 1 year, but only 32 of the intensive rehabilitation group and 28 of the home rehabilitation group had those assessments. The reasons for missing data were not reported. A post hoc subgroup analyzed the 75 study participants whose period of unconsciousness at the time of in- jury was more than 1 hour; 28 of 35 (80 percent) of the group randomized to the inpatient program and 23 of 40 (58 percent) of those randomized to the outpatient program were fit for duty at 1 year (p = 0.05). Vanderploeg et al. (2008) conducted a comparative effectiveness study of patients enrolled in four U.S. Department of Veterans Affairs (VA) in- patient TBI rehabilitation programs. Both arms of the study were inpatient rehabilitation; participants received occupational therapy, physical therapy, speech therapy, TBI education, and social support for 2 hours per day. One arm also included 2 hours per day of cognitive-didactic CRT, while the other arm received 2 hours per day of functional-experiential CRT. CRT was given for up to 60 days (33 days was the mean). For both arms, the average quantity of inpatient interventions was 132 hours per patient. The study reported no difference in primary outcomes of independent living or employment, and no difference on any secondary outcome measures including the FIM, measures of mood and behavior, the Disability Rating Scale, or a self-rating of memory. In subgroup analyses, patients younger than age 30 had better school or work outcomes in the cognitive-didactic arm, while those with higher education and older than age 30 did better in the functional-experiential arm on that primary outcome. Zhu et al. (2007) studied 68 TBI patients with the primary goal of determining whether a higher level of intensity of early inpatient rehabili- tation that included CRT produced better outcomes than a lower intensity of the same intervention. Patients were a mean of 20 days postinjury. The intervention took place 4 hours per day, 5 days per week, for up to 6 months or until discharge, if rehabilitation goals were met. The intervention included social skills training, hearing and speech training, and physical therapy, with goals toward achieving independent living and integration into home and community. The comparator arm received the same content of intervention but at only 2 hours per day (versus 4). These investigators found that Functional Independence Measures (FIM) and Neurobehavioral Cognitive Status Examination (NCSE) scores were no different across the high- and low-intensity rehabilitation arms at 6 months, with substantial gains on average in both arms from enrollment to 6 months. However, the

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217 MULTI-MODAL OR COMPREHENSIVE CRT maximum FIM was achieved by the third month in 47 percent of patients in the high-intensity arm compared to 19 percent of the low-intensity arm. This finding is statistically significant and suggests that early intensive in- patient rehabilitation including CRT may hasten recovery, with maintained long-term outcomes. There was no cost analysis so the value (i.e., health benefit relative to cost) is unknown. For example, it is unknown if earlier discharge translated to lower utilization costs. CONCLUSIONS: SUBACUTE, MULTI- MODAL/COMPREHENSIVE CRT The evidence is not informative for conclusions about the impact (effi- cacy) on patient-centered outcomes (quality of life, functional status) of multi-modal/comprehensive CRT in the subacute phase (Vanderploeg et al. 2008). There is evidence not informative for conclusions about sustainment of treatment effects (through 6 months after treatment) of multi-modal/ comprehensive CRT delivered in the subacute phase (Bowen et al. 1999; Salazar et al. 2000). The evidence is not informative for conclusions about the impact (ef- ficacy) on domain-specific psychometric measures of cognition or func- tioning of multi-modal/comprehensive CRT in the subacute phase (Zhu et al. 2007). In summary, the committee identified and reviewed three RCTs of comprehensive or multi-modal CRT in the subacute phase (Salazar et al. 2000; Vanderploeg et al. 2008; Zhu et al. 2007), and one nonrandomized, parallel group study (Bowen et al. 1999). All three of the RCTs compared some form of CRT in all study arms and had no inert, waitlist, or usual care comparison. The nonrandomized, parallel group study included a usual services arm, but that study had challenges to validity due to the quasi-experimental design and crossover; furthermore, the contents of usual services were not reported. Because the three RCTs do not compare CRT to a group receiving non-CRT therapy or usual care, it is not possible to formulate conclusions about efficacy. Subacute phase patients may not reflect the same patient pool as those who enter the chronic phase and need CRT. Salazar et al. (2000) appeared to have a ceiling effect because 90 percent or more of both treatment groups returned to work, the primary outcome. It is possible that since this study recruited subjects from the subacute phase, a nontrivial proportion might have improved substantially in the first year postinjury regardless

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218 COGNITIVE REHABILITATION THERAPY FOR TBI of intervention, and would not have been seeking or referred for CRT in the chronic phase. It is important to be clear that these subacute studies’ findings cannot be extrapolated to the population of TBI patients in the chronic phase. The primary focus of the committee’s analysis was assessment of the evidence for efficacy. However, the three RCTs did provide information about two other questions: 1. Does CRT in the subacute phase affect rate of recovery? Two RCTs examined this question, but with conflicting results. One RCT (Zhu et al. 2007) found that more intensive rehabilitation led to earlier meeting of milestones for discharge (with outcomes at 6 months being no different). The other (Salazar et al. 2000) found no difference between inpatient and outpatient CRT for rate of readiness to return to duty at 1 year. From these two conflicting findings, it is inconclusive as to whether intensity of CRT in the subacute phase is associated with more rapid attainment of clini- cally meaningful outcomes. 2. Does CRT delivered in the inpatient versus outpatient setting af- fect recovery? One RCT (Salazar et al. 2000) showed no evidence of higher benefit to extending an inpatient, intensive, high-volume CRT program for 8 weeks compared to discharging to a less- intensive, outpatient follow-up program. All participants were eli- gible for discharge to the community at enrollment. A post hoc analysis suggested that those with severe TBI benefitted more from inpatient CRT. CHRONIC PHASE OF RECOVERY The committee reviewed three RCTs (Cicerone et al. 2008; Ruff and Niemann 1990; Tiersky et al. 2005) of multi-modal/comprehensive CRT in patients in the chronic phase of TBI. One of the trials compared CRT to a similar volume of a non-CRT intervention (Ruff and Niemann 1990), and another to a waitlist control condition (Tiersky et al. 2005). Cicerone et al. (2008) compared one format of comprehensive CRT to another form of comprehensive CRT to assess relative or comparative effectiveness of alternate comprehensive approaches. Of six nonrandomized, parallel group design studies identified and described in this review of chronic phase TBI patients, three studies compared comprehensive CRT to a non-CRT pro- gram, and three were comparative effectiveness studies of alternate CRT approaches. Implications of study results are markedly different for studies that compare CRT to an inert comparison or to a non-CRT comparator group, as these studies provide knowledge about efficacy, versus the stud-

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219 MULTI-MODAL OR COMPREHENSIVE CRT TABLE 11-3 Studies in the Chronic Phase of Recovery Treatment Comparator No Study Design Treatment Non-CRT Other CRT Cicerone et al. 2008 RCT X Ruff and Niemann 1990 RCT X Tiersky et al. 2005 RCT X Chen et al. 1997 Parallel X Cicerone et al. 2004 Parallel X Goranson et al. 2003 Parallel X Middleton et al. 1991 Parallel X Parente and Stapleton 1999 Parallel X Sarajuuri et al. 2005 Parallel X Braunling-McMorrow et al. 2010 Pre-Post Cicerone et al. 1996 Pre-Post Huckans et al. 2010 Pre-Post Klonoff et al. 2007, 2010 Pre-Post Mills et al. 1992 Pre-Post Murphy et al. 2006 Pre-Post Rattock et al. 1992 Pre-Post Walker et al. 2005 Pre-Post ies that compare alternative forms of CRT. The latter are comparative effectiveness studies, which do not yield knowledge about efficacy but instead show the relative impacts of the two different approaches. Thus, this section of this review is divided into two components: two RCTs (Ruff and Niemann 1990; Tiersky et al. 2005) and four nonrandomized, com- parison group studies (Chen et al. 1997; Goranson et al. 2003; Parente and Stapleton 1999; Sarajuuri et al. 2005) that compare CRT to a non-CRT arm; and one RCT (Cicerone et al., 2008) and three nonrandomized, com- parison studies (Cicerone et al. 2004; Middleton et al. 1991; Rattok et al. 1992) that compare two alternative forms of CRT. Table 11-3 presents all chronic phase studies by design and treatment comparator. Comparator Group: Non-CRT Content The committee reviewed one RCT of comprehensive CRT in patients with chronic TBI (Tiersky et al. 2005). A large majority of this small trial’s

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220 COGNITIVE REHABILITATION THERAPY FOR TBI participants (29 were randomized; 20 completed the trial) had mild TBI; all enrollees had to be at least 1 year postinjury (mean = 5 years). This study was a pilot trial of an outpatient intervention; no power calculations were reported. The intervention arm received about equal amounts of cognitive remediation (i.e., attention, information processing, memory) and indi- vidual cognitive behavioral therapy in two 50-minute sessions, 3 days per week over 11 weeks; the total intervention time is estimated at 55 hours. The comparator group was placed on a waitlist, and received two or three in-person meetings or phone calls with the principal investigator over the 11-week intervention period (2 or 3 hours total); no therapeutic activities were offered in these contacts. Outcomes were measured at 11 weeks, then at 1 and 3 months after treament. The primary outcome measures were the depression, anxiety, and general symptom indexes of the Symptom Checklist-90R, the PASAT (objective measure of attention), a coping mea- sure, and a self-report measure of attention. There was a significant benefi- cial effect in favor of the intervention (p < 0.05) for the general symptom index, depression, anxiety, and the PASAT. Although the two groups did not differ statistically at baseline on a range of characteristics, the sample was small, and they were qualitatively different on several characteristics, for example, baseline General Symptom Index scores were 1.16 for treatment and 1.62 for controls (p = 0.19). In another RCT, Ruff and Niemann (1990) studied 40 patients with severe TBI 1 year postinjury. This outpatient CRT intervention was 8 weeks long and took place 4 days per week, 5 hours per day (for a total of 160 hours). Sessions included 2 weeks each of CRT targeting attention, spatial integration, memory, and problem solving. Also encompassed within the 5 hours of daily rehabilitation programming was a 50-minute group psycho- therapy session and 30 minutes of wrap-up. The comparator arm was also 160 hours of treatment in an outpatient setting over 8 weeks. The differ- ence was in the content, as this program included computer/video games, sessions on coping skills, group and didactic sessions on healthy lifestyle, small group discussion forums, lectures and workbook exercises on inde- pendence, and art. The comparator arm similarly included 50 minutes daily of group psychotherapy and 30 minutes daily of wrap-up. Cognition was measured in all 40 patients; behavior and adjustment were measured in a subset of 24 patients. Findings showed no between-group differences on outcomes in nine of nine attention measures, five of five spatial measures, five of nine memory measures, and four of four problem-solving measures; performance IQ was also measured. Verbal IQ scores and scores on four of the nine memory measures were better in the CRT arm than the non-CRT comparator arm. In the Saajuuri et al. (2005) nonrandomized, parallel group study, 19 patients with moderate-severe TBI received an inpatient program that

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221 MULTI-MODAL OR COMPREHENSIVE CRT included both neuropsychological rehabilitation and psychotherapy. The program took 210 hours (7 hours per day, 5 days per week, for 6 weeks). To be included, participants had to be judged as independent in daily life and have “adequate potential to achieve productivity” with “special” re- habilitation. At one rehabilitation facility, 23 patients (three were lost to follow-up) were identified for a comparison group out of a series of 213 patients at a different facility, who had sustained head injuries during the same time frame as those receiving the CRT intervention program; all 23 were judged as meeting the same criteria for the intervention program. The control group received care as usual, including both clinical and re- habilitation care services. A mailed questionnaire 2 years after completing the program (for the intervention group) or a comparable interval (for the comparison group) asked about paid and unpaid work or current student status; 2 of 19 receiving the intervention compared to 9 of 20 of the usual care group were not engaged in any productive activity at follow-up (p = 0.017). When categorized by full-time paid employment, only 1 of the 19 intervention compared to 7 of the 20 usual care group met this benchmark. Chen et al. (1997) enrolled 40 patients in a study that compared hierar- chical computer-assisted cognitive rehabilitation delivered in an outpatient setting to “various other therapies including speech therapy and occupa- tional therapy.” Twenty patients who had received the computer-assisted cognitive rehabilitation program and had undergone pre-post evaluations of neuropsychological function were drawn from a database at one center; 20 patients from three other centers who had received other services were drawn from those centers’ records. The study was small, and the interven- tion and comparison arm participants differed substantially on several key characteristics including time since injury and length of coma. There were no significant differences between groups in pre-post score changes. In the Parente and Stapleton (1999) study, outcomes were assessed among 33 TBI patients who had been referred to a rehabilitation program and given a program that included cognitive skills group sessions, com- puter training, training in use of electronic aids such as tape recorders or personal organizers, interviewing skills training, and peer teaching. Aver- age participation duration was 4 months. However, the analysis sample only included 13 patients who had completed the program at the time the outcome evaluation was conducted. The comparison group was 64 subjects pulled from a database of 568 brain-injured patients who received services during the same time frame; the actual amount and type of services received by these subjects were unknown. While 10 of the 13 (76 percent) who re- ceived the intervention program were employed compared to 58 percent of the comparison group, the number in the intervention program analysis is very small, the comparison group could have differed significantly from the intervention group, and what the intervention impact is being compared to

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222 COGNITIVE REHABILITATION THERAPY FOR TBI (in terms of content and extent of services that might have included CRT) is completely unknown. Goranson et al. (2003) retrospectively identified 42 mild TBI patients from existing clinical files. These patients were described as a small group of TBI patients seen at that clinic over 4 years. The study required patients have returned for follow-up outcome data collection at 6 and 18 months after initial collection. The intervention group comprised 21 patients who met the rehabilitation institution’s criteria for an outpatient CRT program that targeted attention, memory, reasoning, and problem solving, as admin- istered by providers from multiple disciplines. Treatment was provided for 4 days per week and 5.5 hours per day, for an average of 4 months (range of program duration was 1 to 7 months). Another 21 patients were identi- fied for the comparison analysis, selected to provide a similar distribution on age, education, and gender to the intervention group. Of note, however, most of the patients in the comparator “no rehabilitation” group did not meet inclusion criteria for the CRT program and thus were different from the group that did receive the CRT program. The study sample was in the chronic phase of recovery for mild TBI, on average 12 to 13 months postinjury. Those who received the CRT program had better Community Integration Questionnaire (CIQ) scores on the Home Integration scale at follow-up, adjusting for differences in baseline scores. There were no dif- ferences across groups on the CIQ Social Integration or Productivity scores. Again, the study is small, the intervention and comparison groups were not comparable because the majority of the comparison group was ineligible for the CRT program, and the sample selected for the analysis may have been prone to substantial selection bias because it represented a small sub- set who, for reasons not described, returned to the facility for follow-up outcome measurement. Comparator: Other CRT Content In an RCT, Cicerone et al. (2008) compared two alternative approaches to outpatient comprehensive CRT. One group of 34 patients was random- ized to receive an intensive outpatient cognitive rehabilitation program, with an emphasis on metacognition and emotional regulation. The program included 11 hours per week of cognitive, communication, and life skill groups plus individual therapy (4 hours per week), over 16 weeks, for a to- tal of 240 hours of outpatient CRT. Another group of 34 study participants were randomized to a different outpatient comprehensive interdisciplinary day treatment of standard neurorehabilitation, which included retraining of discrete cognitive functions through individual therapy and individual- ized physical, occupational, and speech therapy, as well as counseling and some group sessions. Treatment also took place over 16 weeks, 15 hours per week, for a total of 240 hours of outpatient CRT. The study found that

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223 MULTI-MODAL OR COMPREHENSIVE CRT intensive cognitive rehabilitation yielded better scores on measures of com- munity integration, life satisfaction, and self-efficacy, compared to the stan- dard neuro-rehabilitation arm; neuropsychological functioning improved in both arms, but did not differ across groups at follow-up. Of the three nonrandomized, parallel group studies comparing alterna- tive forms of CRT, Cicerone et al. (2004) enrolled 56 patients with TBI in a study that compared a 320-hour inpatient cognitive rehabilitation pro- gram that included individual and group cognitive remediation (4 days per week, 5 hours per day, 16 weeks) to a 288-hour standard inpatient neuro- rehabilitation program of physical, occupational, and neuropsychologi- cal therapies that “incorporated many of the principles of comprehensive neuro-psychological rehabilitation” but in a less structured, less intense fashion. The intensive CRT treatment arm had significantly better Com- munity Integration Questionnaire scores after program completion, despite being in the chronic phase (mean = 34 months from injury) compared to the less intensive CRT arm, which was in the subacute phase (approximately 5 months postinjury). Middleton et al. (1991) compared outcomes of two alternative forms of computer-assisted neuropsychological educational treatment at 8 weeks. Both treatment programs had 96 hours of training on attention, concentra- tion, perceptual skills, and problem-solving skills. Of the participants, 18 received an additional 32 hours of computer-assisted attention and memory training, and 18 other participants received instead 32 hours of computer- assisted reasoning and logical thinking training. There is neither a descrip- tion of how participants were allocated into each group, nor of the process for their selection out of eligible participants. Both groups had statistically significant gains in five of six neuropsychological test measures, but there were no between-group differences at follow-up. Rattok et al. (1992) enrolled 59 patients with TBI in three different arms; all arms received 140–160 hours of attention training, community activities, and counseling. In addition, one arm received 220 hours of cogni- tive remediation and small-group interpersonal exercises, one arm received 200 hours of small group interpersonal exercises but no cognitive remedia- tion, and one arm received 200 hours of cognitive remediation but no small group interpersonal exercises. The process for assigning participants to study arms was not described. The 400 hours of CRT were delivered over 20 weeks in an outpatient setting. Among the many outcome measures, no patterns of between-group differences emerged. Pre-Post Designs The committee reviewed seven studies of a pre-post design without any comparison or control group (Braunling-McMorrow et al. 2010; Cicerone et al. 1996; Huckans et al. 2010; Klonoff et al. 2007, 2010; Mills et al.

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232 TABLE 11-1 Continued TBI Severity Study N Level Brief Narrative Comparator Outcome Measures Findings Chen et al. 40 NR Examined the Y • WAIS-R subtests: CACR made significant gains 1997 effectiveness of computer- ▪ Information on the neuropsychological assisted cognitive Other CRT ▪ Vocabulary test on 15 measures, rehabilitation (CACR) Content: Control ▪ Digit span, symbol compared to seven by involving a hierarchical group received ▪ Arithmetic the comparison group. In sequence of training steps no or low doses ▪ Comprehension contrast, the investigators beginning in fundamental of CACR, but ▪ Similarities found no significant functions and advancing did receive other ▪ Picture completion differences between groups to more complex cognitive therapies, like ▪ Picture arrangement on posttreatment gains. processes. speech therapy ▪ Block design and occupational ▪ Object assembly therapy • Category test • Trail Making Test • Wisconsin Card Sorting test • WMS and WMS-R • Digit span forward, backward • Logical memory immediate, delayed • Visual reproduction immediate, delayed • Paired associates immediate, delayed

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Cicerone et 56 Mild, This study compared Y • CIQ Both groups improved al. 2004 Moderate, the effectiveness of • Quality of Community significantly on the CIQ, Severe an intensive cognitive Other CRT Integration Questionnaire with the ICRP participants rehabilitation program Content: (QCIQ) twice as likely to show (ICRP), a highly Standard • Trail Making Test clinical benefits, compared structured program neurorehabilitation • California Verbal Learning to the SRP group. ICRP integrating cognitive including physical, Test participants, as well as those and psychosocial occupational, and • Rey Complex Figure with clinically significant interventions. speech therapies, • COWAT improvement on the as well as • Category Test CIQ, showed significant neuropsychologic overall improvement treatment in neuropsychologic functioning. Middleton et 36 NR Investigates outcomes Y • WAIS-R, Digit Span There was significant al. 1991 following computer- • Wechsler Paired Associates improvement on five of six delivered cognitive Other CRT • Knox’s cube measures by both groups rehabilitation therapy, Content: • Block Counting at 8-week follow-up; no comparing two forms Control received • Concept formation differential effect was of computer-assisted computer-assisted • Shipley Abstraction observed in the treatment neuropsychological training on group. treatment targeting reasoning and attention and memory logical thinking skills or reasoning and skills logical thinking skills. 233 continued

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TABLE 11-1 Continued 234 TBI Severity Study N Level Brief Narrative Comparator Outcome Measures Findings Parente and 33 NR In a pilot study, evaluated Y Return to work Participants in the CSG had Stapleton the effectiveness of a 76 percent vocational 1999 the Cognitive Skills Other CRT rehabilitation rate, i.e., Group (CSG) providing Content: placement in competitive thinking skill training as Similar services but employment; 58 percent of a precursor to vocational not within CSG the baseline participants placement. The sequence returned to work. of topics include problem solving, concentration/ attention, decision making, remembering faces and names, study skills, functional mnemonics, prosthetic memory devices, social cognition, organizational skills, goal setting, non- verbal perception, specific study skills, and test- taking strategies.

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Rattok et al. 59 severe Assessed three groups Y • Orientation Remedial All three treatment mixes 1992 with varying treatment Module (ORM) were equally effective in combinations of attention Other CRT • Purdue Pegboard all areas, with some mixes training, cognitive Content: • Visual processing skills producing superior results to remediation, small-group Group 1 received • Academic skills others in some respects (e.g., interpersonal exercises, cognitive • WAIS – verbal, with regard to intra- and community activities, and remediation with performance interpersonal functions, the personal counseling. Each small-group • Psychomotor dexterity mixes that emphasized group group received a total of interpersonal • Higher order and interventions were superior 400 hours of training. exercises; Group 2 conceptual skills to Mix 3 in some respects). Cognitive remediation stressed small- involved task and curing group interpersonal hierarchies, constructional exercises; Group 3 praxis, visual information involved cognitive processing, and logical remediation reasoning. without small- group time; all three groups received attention training. Sarajuuri et 39 Moderate- Evaluated outcome Y Structured self-report At two-year follow-up, the al. 2005 Severe following a questionnaire: treatment group improved comprehensive, 6-week Other CRT • Gainful work (full or part significantly more than the neurorehabilitation Content: time) control; 89 percent of treated program with Conventional care • Education/studying patients were productive, psychotherapy and and rehabilitation • Household management compared with 55 percent of vocational interventions • Supported or sheltered the control group. as well as follow-up work support. • Work trials • Productive but nongainful work (full or part time) • Volunteer work 235 continued

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TABLE 11-1 Continued 236 TBI Severity Study N Level Brief Narrative Comparator Outcome Measures Findings Pre-Post Single Group Braunling- 205 Severe Investigators examined N Functional Area Outcome There were significant Mcmorrow the effect multifaceted Menu: functional gains of et al. 2010 rehabilitation services had • Behavioral and Emotional approximately 1.5 levels, on functional outcomes Status using the rehabilitation for participants with • Community Participation treatment model, for major physical and • Educational Endeavors neuropsychologically cognitive difficulties • Global Quality of Life impaired participants, both (n = 129) and those with • Intimacy/Relationships with and without related behavioral complications • Invovement in Vocational behavioral and substance (n = 76). or Educational Endeavors problems. • Level of Awareness • Level of Independence • Level of Self-Managed Health • Residential status • Vocational Endeavors

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Cicerone et 20 Mild This investigation was N • Attention Neuropsychological al. 1996 a retrospective analysis ▪ Digit Span, Forward and rehabilitation led to of a neuropsychological Backward improved cognitive rehabilitation program ▪ Trail Making Test functioning and a reduction for 20 patients who were ▪ Continuous Performance of post-concussive symptoms part of a larger sample, Test of Attention for those participants referred for treatment ▪ PASAT able to resume productive due to postconcussive • Memory functioning; these symptoms and functional ▪ Logical Memory I and II improvements most affected disability. ▪ California Verbal areas of complex attention Learning Test and information-processing ▪ Rey Immediate Recall speed. Participants who • Higher cognitive function were not able to resume ▪ Rey Copy productive functioning ▪ WCST Perseveration showed decline in functioning ▪ Category Test on various measures at 1- ▪ Mazes and 6-month follow-up. ▪ Verbal Fluency continued 237

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TABLE 11-1 Continued 238 TBI Severity Study N Level Brief Narrative Comparator Outcome Measures Findings Huckans et 21 Mild Investigators piloted N • Beck Depression Inventory There was a significant al. 2010 a Cognitive Strategy • Cognitive Symptom increase in compensatory Training (CST) group Severity strategies (MCQ), use of treatment to examine • Community Integration class strategies and day if an increase in Questionnaire planners (FCSUS), internal compensatory strategies • Frequency of Cognitive cognitive strategies, and use use was observed; they Strategy Usage Scale of extensive cognitive aids. also examined the effect (FCSUS) Secondary analyses showed of CST on self-reported • Memory Compensation significantly lower levels psychiatric symptoms, Questionnaire (MCQ) of depression, lower levels cognitive symptoms, and • Memory Questionnaire of memory and cognitive life satisfaction. • PTSD Checklist impairment, no change in • Satisfaction with Life Scale PTSD symptoms, no change • Severity of Dependence in community integration Scale levels, and a trend toward • TBI self-efficacy scale increased self-efficacy. • Usefulness of Cognitive Strategy Scale (UCSS) Klonoff 103 Mild, Examines cognitive N • Cognitive Retraining In all participants, the et al. 2010 Moderate, retraining offered within Behavior Checklist (CRBC) Matching Shapes cognitive Severe a therapeutic milieu and • Digit Symbol test showed a significant driving outcomes, the • Driving status difference between driving relationship between • Letter Scan (letter H) groups: drivers rated metacognitive processes • Matching Shapes better on organization, and clearance to drive, and • Word Fluency independence, use of the relationship between a • Working Alliance (WA) compensations than non- patient’s working alliance scores drivers, and drivers had (WA) and driving status at higher mean and discharge discharge. WA ratings.

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Klonoff 101 Mild, Examines the effectiveness N • Cognitive Retraining More than 80 percent of et al. 2007 Moderate, of cognitive retraining Behavior Checklist (CRBC) participants returned to work Severe exercises within a milieu- • Digit Symbol or school associated with based rehabilitation on • Driving status better cognitive performance work or school status. • Letter Scan (letter H) in tasks requiring • Matching Shapes information processing speed, • Word Fluency visual scanning, visuospatial • Working Alliance (WA) skills, and memory. • Work/school status Mills et al. 42 Severe Examines outcomes of N • Functional evaluation Patients’ functional outcomes 1992 a 6-week, structured ▪ Identifying community improved significantly outpatient rehabilitation resources post treatment; the overall program, individualized ▪ Consumer skills percentage of goals achieved to each patient, including ▪ Health was 67.5 percent. A positive psychological support ▪ Leisure activities correlation between the and emphasizing ▪ Safety awareness initial functional evaluation improvements in real- ▪ Self-care and cognitive assessments world functional abilities. ▪ Social communication was reported, however there Evaluations included ▪ Telephone skills was no significant correlation family and patient ▪ Time management between the change in interviews to determine ▪ Use of public functional and cognitive day-to-day functioning. transportation outcomes posttreatment, Follow-up evaluations • Individual treatment goals although a trend was were conducted at 6, • Speech pathology indicated. The number of 12, and 18 months post evaluation days in treatment correlated treatment. with functional improvement. 239 continued

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TABLE 11-1 Continued 240 TBI Severity Study N Level Brief Narrative Comparator Outcome Measures Findings Murphy 232 Mild, Evaluates a rehabilitation N • Paid competitive Overall, 72 percent of et al. Moderate, program to contain employment subjects resumed independent 2006 Severe elements of group- • Education or training activity, such as paid based training, followed • Voluntary work competitive employment, by work site-based • Discharge to other services education or training, or rehabilitation including • Client withdrew voluntary work. Of the variable amounts of • Discharged for other remaining participants, hospital- or community- reasons 15 percent were referred based neurological to further rehabilitation rehabilitation. As such, services, and 13 percent of the program was designed the sample withdrew. The to include elements of authors reported that there cognitive rehabilitation as was no significant difference well as site-specific work on severity of injury relative placement training and to outcome. rehabilitation. Walker 11 Severe A pilot study to evaluate N • Individual goals related to: At least one goal was et al. an extensive, three- ▪ Employment achieved by 10 of the 11 2005 stage program that ▪ Study participants, with overall, ultimately focused on ▪ Driving 21 of 26 goals attained. goal identification and ▪ Leisure There were no significant achievement through tasks ▪ Independence differences on psychological analysis and problem • Psychological measures: measures. solving in goal areas. ▪ Depression, Anxiety, and Stress Scales ▪ General Well-Being Questionnaire ▪ European Brain Injury Questionnaire, family rating

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