| | A Randomized Controlled Trial of Holistic Neuropsychologic Rehabilitation After Traumatic Brain InjuryPresented preliminary results at the Annual Meeting of the American Congress of Rehabilitation Medicine, October 9, 2007, Washington DC. Abstract Cicerone KD, Mott T, Azulay J, Sharlow-Galella MA, Ellmo WJ, Paradise S, Friel JC. A randomized controlled trial of holistic neuropsychologic rehabilitation after traumatic brain injury. ObjectiveTo evaluate the effectiveness of comprehensive, holistic neuropsychologic (NP) rehabilitation compared with standard, multidisciplinary rehabilitation for people with traumatic brain injury (TBI). DesignRandomized practical controlled trial. SettingPostacute brain injury rehabilitation center within a suburban rehabilitation hospital. ParticipantsParticipants with TBI were recruited from clinical referrals and referrals from the community. Sixty-eight participants who met inclusion criteria were randomly allocated to treatment conditions. Most participants (88%) had sustained moderate or severe TBI, and greater than half (57%) were more than 1 year postinjury at the beginning of treatment. InterventionsTreatment was conducted 15 hours per week for 16 weeks. Standard neurorehabilitation consisted primarily of individual, discipline specific therapies (n=34). Intensive cognitive rehabilitation emphasized the integration of cognitive, interpersonal, and functional interventions within a therapeutic environment (n=34). Main Outcome MeasuresPrimary outcomes were the Community Integration Questionnaire (CIQ) and Perceived Quality of Life scale (PQOL). Secondary outcomes included NP functioning, perceived self-efficacy, and community-based employment. ResultsNP functioning improved in both conditions. Intensive cognitive rehabilitation participants showed greater improvements on the CIQ (effect size [ES]=0.59) and PQOL (ES=0.30) as well as improved self-efficacy for the management of symptoms (ES=0.26) compared with standard neurorehabilitation treatment. These gains were maintained at the 6-month follow-up. Standard neurorehabilitation participants showed improved productivity at the 6-month follow-up associated with the need for continued rehabilitation. ConclusionsImprovements seen after intensive cognitive rehabilitation may be related to interventions directed at the self-regulation of cognitive and emotional processes and the integrated treatment of cognitive, interpersonal, and functional skills. The results show the effectiveness of comprehensive holistic NP rehabilitation for improving community functioning and quality of life after TBI compared with standard rehabilitation. List of Abbreviations: ANOVA, analysis of variance, CIQ, Community Integration Questionnaire, ES, effect size, ITT, intent-to-treat analysis, NP, neuropsychologic, PABIR, post–acute brain injury rehabilitation, PQOL, Perceived Quality of Life Scale, TBI, traumatic brain injury, TMT-A, Trail-Making Test part A, TMT-B, Trail-Making Test part B PABIR REQUIRES A COMPREHENSIVE approach to treating the residual problems of people with TBI months and years after the initial injury. In their review of PABIR programs, Malec and Basford1 described a number of specialized programs, including multidisciplinary, outpatient treatment, and comprehensive holistic rehabilitation programs. Within programs, treatment is provided to improve cognitive skills, practical skills, or both, and the basic features of these programs may overlap with the characteristics of NP-oriented rehabilitation.2 Comprehensive holistic rehabilitation programs typically provide individual- and group-based therapies within an integrated, therapeutic environment.3, 4 In addition to addressing discrete cognitive limitations, comprehensive holistic rehabilitation programs may have a more general focus on metacognition (eg, awareness and self-appraisal), interpersonal functioning, and emotional regulation.1, 3 The goal of comprehensive holistic NP rehabilitation is not only, or primarily, the remediation of cognitive impairments but the establishment of a meaningful and satisfactory life in the face of persisting limitations.5 Clinical studies of PABIR have shown improvements in community integration, social participation, and productivity6, 7, 8, 9, 10 by patients 1 or more years after TBI,11 with gains maintained for several years after rehabilitation.12, 13 Prospective observational studies support the effectiveness of comprehensive holistic NP rehabilitation compared with no-treatment14 or conventional rehabilitation.15 Randomized controlled studies of comprehensive holistic NP rehabilitation16, 17, 18 have shown more limited evidence of effectiveness, although these studies have significant methodologic limitations. Ruff et al16, 17 recruited volunteer participants from the community who were motivated to participate in treatment. Computer-based treatment of specific cognitive abilities was compared with treatment emphasizing psychosocial adjustment and activities of daily living. Both groups showed a significant improvement of NP functioning16 and depression17 that could not be attributed to specific treatment components. These findings are consistent with the view that improvements in functioning are best achieved through a combination of cognitive, psychosocial/interpersonal, and functional interventions.4 The second randomized controlled trial18 evaluated the efficacy of comprehensive holistic NP rehabilitation through an inpatient milieu-oriented program modified to fit into a military framework compared with limited, home-based TBI education and counseling. Participants represented a selective sample of military personnel in the acute stage of recovery. Participants in both groups showed extraordinarily high return-to-work rates 1 year postinjury, although severely injured participants were more likely to benefit from cognitive rehabilitation. Neither of these studies used a clinically representative sample of patients receiving PABIR, and neither program was fully representative of comprehensive holistic NP rehabilitation compared with a clinically viable intervention. We previously conducted an observational study comparing comprehensive holistic cognitive rehabilitation (the Intensive Cognitive Rehabilitation Program) with standard multidisciplinary, outpatient rehabilitation (the Standard Neurorehabilitation Program) for people with TBI.19 Participants who received the intensive cognitive rehabilitation program were twice as likely to make clinically significant improvements in community integration. There was a bias in assigning patients to treatment alternatives, which resulted in the intensive cognitive rehabilitation program patients being more severely disabled and farther postinjury. Satisfaction with cognitive functioning was strongly related to community integration, particularly after the intensive cognitive rehabilitation program. We speculated that this might reflect participants' perceived self-efficacy and that comprehensive holistic NP rehabilitation might increase self-efficacy beliefs as well as improving cognitive skills. The present study is a prospective, randomized clinical trial comparing the effectiveness of the Intensive Cognitive Rehabilitation Program and the Standard Neurorehabilitation Program after TBI. The study was designed as a practical clinical trial, investigating clinically relevant alternative treatments in a representative sample of people with TBI by using a range of health-related outcome measures.20, 21 We hypothesized that the Intensive Cognitive Rehabilitation Program would result in greater improvements in community integration, productivity, and life satisfaction than the Standard Neurorehabilitation Program. Second, we expected both treatments to produce improvements in NP functioning, without predicting any difference between treatment conditions. Although we did not expect differences in NP functioning between programs, we hypothesized that the Intensive Cognitive Rehabilitation Program would be associated with greater improvements in participants' self-efficacy to manage residual cognitive and emotional symptoms. Methods  Enrollment and Randomization The study occurred at a postacute brain injury rehabilitation program and TBI Model System of Care in a suburban rehabilitation hospital in the northeastern United States. Criteria for admission to the rehabilitation program were (1) medical stability, (2) independence in basic self-care (eg, feeding, toileting), and (3) clinical judgment of potential to benefit from comprehensive rehabilitation. Participants included patients who were clinically referred for postacute rehabilitation for whom the referral was part of a continuous pathway of care. Participants also included self-referrals and referrals from the community. These participants were enrolled primarily through outreach to statewide TBI support groups and organizations and mailings to community physicians and hospitals. Community-referred participants had not received rehabilitation therapies or other clinical treatment related to their injury for at least 6 months before their enrollment. To be eligible for the treatment study, participants had to (1) have medical documentation of TBI based on a primary source within 24 hours of injury (eg, emergency medical services or hospital admission records), (2) be at least 3 months postinjury, (3) be 18 to 62 years of age, (4) have adequate language expression and comprehension (with or without assistive device) to participate in verbally based group interventions (ie, participants had to be English speaking and could not be severely aphasic), (5) be judged to require at least 4 months of comprehensive treatment, (6) be clinically appropriate for either arm of treatment, (7) be capable of attending treatment 3 days per week, and (8) be capable of giving informed consent. Participants with a history of prior TBI, premorbid learning disability, psychiatric disorder, or substance abuse were not excluded; participants were excluded if they had active psychiatric illness, substance abuse, or pain considered at the time of enrollment to prevent their compliance with treatment. Patients enrolled in the study were not required to have external funding for treatment, and most participants were unfunded or underfunded for rehabilitation. Participants were allowed to have received prior treatment and to continue treatment after the 16-week study period as clinically indicated. Randomization was conducted through the web-based interactive statistical calculation pages (www.statpages.org) to allocate 48 participants per condition. Randomization occurred in unequal, blocked multiples of 4 to optimize equal assignment of participants to treatment arms throughout the study period and prevent anticipation of the randomization sequence. Randomization was stratified by referral source (clinical or community referrals) to optimize equal assignment between treatment arms. The allocation of participants to treatment condition was concealed by placing the individual randomized assignments in sequentially numbered, opaque, sealed envelopes. Participants were randomized in the order they provided written informed consent. Potential participants were informed that both conditions were clinically established treatments that differed in how they were structured and organized, that we expected them to benefit from either treatment, and that we did not know if one treatment was better than the other. The study was approved annually by the Solaris Health System Institutional Review Board. Participants Participants were enrolled and completed treatment between January 2003 and December 2006. One hundred sixty-four patients were screened for eligibility (fig 1). Ninety-five patients were excluded: 22 refused participation, 37 did not require 4 months of comprehensive treatment, in 3 patients 1 of the treatment arms was believed to be clinically contraindicated (primarily because of the need for physical rehabilitation), 13 patients did not have medical documentation of a TBI, 4 were excluded because of active psychiatric illness, 6 were excluded because of pain as a primary complaint, 1 had severe aphasia, 2 were non-English speaking, 4 did not meet inclusion criteria for age, and 3 did not have transportation to treatment. Sixty-nine participants were randomized. One withdrew consent before completing the baseline evaluation and is not included in the analyses. Of the remaining 68 participants, 34 received the Intensive Cognitive Rehabilitation Program and 34 received the Standard Neurorehabilitation Program treatment. Among participants enrolled in the study, 90% had been hospitalized for their TBI and 81% had received inpatient rehabilitation. Sixty-nine percent had received some prior outpatient rehabilitation (typically limited therapies or a prior course of standard neurorehabilitation program treatment; no participant had received a prior course of intensive cognitive rehabilitation program). Four percent had a previous TBI, 13% had a history of psychiatric illness, and 21% had a history of substance abuse. None of the participants were considered aphasic. Forty-seven participants (69%) were clinical referrals, and 21 (31%) were community referrals. More than half the participants (57%) were over 1 year postinjury at the beginning of treatment, with an average time postinjury of 43.3 months for all participants. The severity of injury was determined by any combination of initial Glasgow Coma Scale score, duration of unconsciousness, duration of posttraumatic amnesia, and positive neuroimaging available from the primary medical records. Forty participants (59%) sustained severe injury, 16 (24%) sustained moderate injury, 9 (13%) sustained mild injury, and we were unable to determine severity for 4 participants (3%). There were no differences between treatment conditions on any of these characteristics. The groups were equivalent on all outcome measures before treatment. Two participants withdrew from Intensive Cognitive Rehabilitation Program treatment: 1 within the first week of treatment and 1 subsequent to an episode of psychiatric symptomatology and substance abuse. Four participants withdrew from the Standard Neurorehabilitation Program treatment: 1 did not complete treatment because of psychiatric hospitalization, and 3 completed the planned treatment but refused posttreatment evaluations in association with increased psychiatric symptoms. An additional 4 participants did not respond to requests for 6-month follow-up evaluation: 2 from the Intensive Cognitive Rehabilitation Program and 2 from the Standard Neurorehabilitation Program. Interventions Both the Intensive Cognitive Rehabilitation Program and the Standard Neurorehabilitation Program consisted of clinically established treatment programs that were based on principles of NP rehabilitation2 but differed in their treatment orientation and program structure. Both treatments were conducted simultaneously within the same postacute rehabilitation program, with the same therapists providing treatment in both conditions. It was not feasible for therapists to be blind to treatment condition. However, therapists were informed that the study was being conducted because we did not know if 1 form of treatment was better than the other, with no additional information about the full intent of the study. Therapists were not informed about the specific hypotheses or outcome measures. Both treatment arms provided 15 hours per week of therapy for 16 weeks. During the study treatment, participants continued their existing medical care and were allowed to continue psychologic counseling or psychotherapy but were not receiving other therapies. Treatments in both treatment arms were individualized according to participants' clinical needs to the extent possible. Participants in the Standard Neurorehabilitation Program condition initiated treatment on a continuous basis. Participants in the Intensive Cognitive Rehabilitation Program condition initiated treatment simultaneously in small groups of 5 to 8 participants, and group membership remained consistent throughout each 16-week treatment cycle. Adherence to treatment protocols was monitored through weekly meetings of the study's therapists and investigators, with particular attention to preventing bleedover of techniques across treatment conditions. Treatment fidelity was also assessed at the end of the study with a scale of treatment orientation developed for this study. Therapists involved in both interventions completed the scale, ranking the degree to which 15 aspects of treatment were characteristic of Intensive Cognitive Rehabilitation Program and Standard Neurorehabilitation Program treatments. Intensive Cognitive Rehabilitation Program The treatment orientation of the Intensive Cognitive Rehabilitation Program was based on principles of comprehensive holistic NP rehabilitation3, 5 emphasizing the integration of interventions for cognitive deficits, emotional difficulties, interpersonal behaviors, and functional skills within the context of a therapeutic environment. There was an emphasis on performance feedback and active self-evaluation throughout the group process. Treatment was centered on participants' adaptation to the chronic limitations imposed by their injury to alleviate restrictions in everyday functioning. Treatment was guided by the assumption that improvements in functioning are accomplished through the effective application of residual cognitive abilities, rather than the restoration of the underlying cognitive deficits per se. All Intensive Cognitive Rehabilitation Program interventions emphasized metacognition (self-monitoring and self-regulation) and emotional regulation. These processes were reinforced through 2 interventions specific to the Intensive Cognitive Rehabilitation Program condition that were embedded within all therapy sessions and homework assignments. A structured activity analysis was based on the cognitive determinants of self-efficacy22, 23: (1) identification and analysis of the specific requirements of the task, (2) personal attributes that might influence performance (eg, cognitive strengths and limitations, emotional reactions, interests, and motivation), (3) situational factors that might influence performance (eg, competing demands, time limits, social supports), and (4) predicting their confidence and likelihood of success in carrying out the activity. Emotional monitoring and regulation were facilitated through the use of a Cognitive Energy Scale developed specifically for the Intensive Cognitive Rehabilitation Program. The Cognitive Energy Scale consisted of a 5-point scale adapted by each participant using personally relevant descriptors to identify and monitor fluctuations in their cognitive, emotional, somatic, and motivational levels throughout each treatment day (eg, 1=tired, hard to pay attention, cannot engage in group discussion; 3=alert, able to focus, actively participating; 5=anxious, distracted, feeling overwhelmed). Participants were encouraged to use the Cognitive Energy Scale, both at regular treatment intervals and extemporaneously, to monitor their emotional status and implement self-regulatory strategies. Interventions were designed to incorporate a combination of success and experience in overcoming obstacles to build a resilient sense of self-efficacy and control over events. The Intensive Cognitive Rehabilitation Program treatments were organized around specific themes, which resembled the treatment phases described by Ben-Yishay and Gold.3 Weeks 1 through 4 were devoted to establishing group process and fostering group cohesion, engagement in treatment, and use of peer and therapist feedback. Participants also developed strategies for maintaining attention and participated in didactic and experiential exercises to facilitate awareness of limitations and the use of compensatory strategies. Weeks 5 through 8 were directed at the acquisition and practice of strategies reflecting each participant's identified problem areas and goals. Treatment exercises focused on task analysis, planning and organization, goal setting, and social problem solving. There was an emphasis on relating the problems and compensations experienced within treatment sessions to similar situations in participants' daily activities. Weeks 9 through 12 focused on the independent application and carryover of compensatory strategies, refinement of participant's goals and expectations, and finding the benefits of new roles. Weeks 13 through 16 were focused on generalization of strategies to everyday functioning, positive acceptance of role limitations, and transition to the community. The core structure of the Intensive Cognitive Rehabilitation Program consisted of 15 hours of individual and group therapies conducted 3 days a week. All Intensive Cognitive Rehabilitation Program participants received 11 hours of group treatment a week. The cognitive group (2h/d, 3d/wk) used a variety of functional and social problem-solving tasks.24, 25 The final 20 to 30 minutes of each cognitive group was attended by all Intensive Cognitive Rehabilitation Program therapists and was devoted to reviewing the group process, summarizing the activities of the group, and highlighting partcipants' individual problems and progress in conjunction with the themes of treatment through patients' narratives. The communication group was conducted twice a week (2h 1 day, 1h 1 day) and addressed patients' pragmatic and interpersonal communication through role playing, interpersonal and videotaped feedback, and analysis of social interactions. The life skills group (1h/d, 2d/wk) reinforced functional compensatory strategies (eg, note-taking) and the application and monitoring of strategies within each participant's home and community, including regular homework exercises. Intensive Cognitive Rehabilitation Program participants received 3 hours of individual therapy from a primary therapist. Primary therapy sessions typically provided cognitive remediation, relating individual cognitive interventions to group treatments and making explicit the relation between the participant's treatments and everyday functioning. Primary sessions could also include counseling on psychologic, vocational, or educational issues based on participants' clinical needs. All participants were followed by a neuropsychologist and received 1 hour per week of individual NP treatment. Standard Neurorehabilitation Program The Standard Neurorehabilitation Program treatment was also conducted as a comprehensive, interdisciplinary day treatment program and was designed to be responsive to the stage and rate of recovery after brain injury.1, 2 The Standard Neurorehabilitation Program treatment orientation was largely guided by discipline-specific interventions targeting specific deficit areas, including retraining of discrete cognitive functions, and conducted primarily through individual therapies. The structure of Standard Neurorehabilitation Program treatment consisted of individual therapies including physical therapy, occupational therapy, and speech therapy. All patients were followed by a neuropsychologist, and most participants received 1 hour a week of individual NP treatment. NP treatment in the Standard Neurorehabilitation Program and Intensive Cognitive Rehabilitation Program conditions were equivalent and generally addressed awareness of deficits and strategies to improve cognitive functioning. Participants could receive 1 hour of psychologic counseling and 1 hour of recreation therapy, vocational counseling, or educational counseling. Participants in the Standard Neurorehabilitation Program treatment could receive a limited number of group treatments (≤3h/wk). The amount and combination of specific treatments for each participant in the Standard Neurorehabilitation Program condition varied based on individual needs and routine clinical decision making. Outcome Measurement The primary outcome measures were the CIQ and PQOL. The secondary outcome measures were NP functioning, perceived self-efficacy, and vocational activity. Outcome measures were administered within the 2 weeks before commencing the treatment protocol (pretreatment) and within 2 weeks after the completion of each participant's treatment protocol (posttreatment). Follow-up assessment with the CIQ, PQOL, self-efficacy, and vocational status was obtained at 6 months after participants' completion of the study treatment protocol. The CIQ, PQOL, and self-efficacy were administered as self-report measures under supervision. Data entry and scoring for these measures were conducted by a research assistant who was blind to treatment condition. Primary Outcome Measures Community integration Functioning in the community was assessed with the CIQ.26 The CIQ was developed to assess participation within the home, in social interactions, and in productive activities and has been used extensively among people with TBI.26, 27 Sander et al28 examined the factor structure of the CIQ and identified 3 factors reflecting home competency, social integration, and productive activity. Sander28 modified the scoring procedure to correspond with their empirically derived factors; these recommendations were followed with the CIQ in the present study. The total CIQ score was used as the primary outcome measure, although we also examined subscale scores for home competency (CIQhome), social integration (CIQsoc), and productive activity (CIQprod). Life satisfaction The PQOL was initially developed as a cognitive appraisal of life satisfaction for patients after intensive medical care.29 The modified PQOL has been used with adults with chronic neurologic disability including stroke30 and TBI.31, 32 The PQOL measures the degree to which the individual is satisfied with his/her functioning on a 10-point scale ranging from extremely dissatisfied to extremely satisfied. The PQOL assesses 10 areas of functioning including physical health, thinking and remembering, family relationships, community participation and leisure, work and income, and meaning and purpose of life. The overall PQOL score may be considered a measure of global life satisfaction. We used the total score, ranging from 10 to 100, in the current analyses. The PQOL has been shown to have good internal reliability in a sample of 97 people who had sustained a TBI at least 6 months previously and were living in the community (Cronbach α=.89).32 Secondary Outcome Measures NP functioning A brief NP test battery was administered to assess attention, memory, and higher cognitive functioning. Attention and processing speed were evaluated with the TMT-A.33 Memory functioning was evaluated with the total acquisition score from the California Verbal Learning Test-II34 and immediate recall score for the Rey Complex Figure.35 Higher cognitive functioning was assessed with the TMT-B,33 Controlled Oral Word Association Test,36 and Booklet Category Test.33 All raw scores were converted to T scores demographically corrected for age and/or education. In a small number of cases, it was not possible to administer all NP measures, typically because of sensory or motor impairments. In these cases, the mean value for the other pretreatment measures was imputed for the missing scores. A composite score (NP) reflecting overall NP functioning was based on the mean T score. NP evaluations were administered and scored by a staff neuropsychologist who was not involved in treatment and was not aware of participant's treatment condition. Perceived self-efficacy Perceived self-efficacy for the management of symptoms was adapted from a measure developed for people with chronic medical disability37 and modified specifically for use with TBI.32 Each item is preceded by the question How confident are you that you can … with responses on a 1- to 10-point scale from not at all confident to totally confident. The resulting scale has been shown to retain the factor structure of the original instrument and show good internal reliability (Cronbach α=.93) among 97 people with TBI living in the community.32 The primary outcome measure in the present study was the total score for all 13 self-efficacy for management of symptoms scale (total self-efficacy) items. We also examined subscales derived from the 4 items assessing the ability to obtain assistance (self-efficacy social), 4 items assessing self-management of cognitive symptoms (self-efficacy cognitive), and 4 items assessing self-management of emotional symptoms (self-efficacy emotional); the single remaining item assessing self-management for physical symptoms was not analyzed separately but was included in the total score. Community-based employment Vocational and educational outcomes were evaluated for all participants by using the Vocational Integration Scale.9 The Vocational Integration Scale is a 5-point rating reflecting the following categories: (1) unemployed, (2) sheltered employment, (3) supported employment (ie, job coaching or other permanent supports), (4) transitional employment (education, job coaching, or other temporary supports), and (5) competitive employment. We collapsed ratings to a dichotomous variable to classify participants as engaged in community-based employment (Vocational Integration Scale levels 3–5) or unemployed (Vocational Integration Scale levels 1–2), consistent with prior use of this measure.9 Statistical Analyses The effects of treatment were analyzed by using multivariate, repeated-measures ANOVA (SPSS version 14)a to investigate changes from the pretreatment to posttreatment (treatment effect) and compare between the Intensive Cognitive Rehabilitation Program and Standard Neurorehabilitation Program intervention (condition). ITT analyses were conducted by carrying forward the pretreatment baseline scores for the 6 participants who failed to complete their respective treatment protocol and/or posttreatment outcome measures. Post hoc analyses were conducted only after a variable had shown significance on the planned multivariate ANOVA by using within-group paired-sample t tests to determine the source of significance. We examined treatment interaction ES for differences between groups from pretreatment to posttreatment by using a variant of Hedge's g for the comparison of independent group prepost-treatment scores that accounts for differences in pretreatment variance between groups38 ([mean intensive cognitive rehabilitation programposttreatment − mean intensive cognitive rehabilitation programpretreatment/SD intensive cognitive rehabilitation programpre-treatment] − [mean standard neurorehabilitation programposttreatment − mean standard neurorehabilitation programpretreatment/SD standard neurorehabilitation programpretreatment]). Results There were no differences between conditions on demographic characteristics (table 1), injury-related characteristics (table 2), or pretreatment measures (Table 3, Table 4). Table 3, Table 4 depict the descriptive statistics for the ITT analyses at pretreatment baseline, posttreatment outcome, and 6 month follow up. (Descriptive statistics for participants completing treatment and follow-up are available from the first author.) Table 5 presents inferential statistics for the ITT analyses. | | |  | Characteristic | STD | ICRP | |
|---|
| N | 34 | 34 | | | Age (y) (mean±SD) | 34.5±12.4 | 38.7±11.1 | | | Education (y) (mean±SD) | 12.5±1.2 | 13.2±1.9 | | | Sex (%) | | | | |  Men | 21(62) | 25(74) | | | Women | 13(38) | 9(27) | | | Race (%) | | | | | White | 24(71) | 27(79) | | | Black | 4(12) | 3(9) | | | Hispanic | 5(15) | 3(9) | | | Asian | 1(3) | 1(3) | | | Marital status (%) | | | | | Single | 18(53) | 17(50) | | | Married | 11(32) | 13(38) | | | Divorced/separated/widowed | 5(15) | 4(12) | | | Employment preinjury (%) | | | | | Employed | 27(80) | 27(80) | | | Unemployed | 2(6) | 1(3) | | | Homemaker | 1(3) | 0(0) | | | Student | 3(9) | 6(18) | | | Retired | 1(3) | 0(0) | | | | |
| | | | Characteristic | STD | ICRP | |
|---|
| N | 34 | 34 | | | Months postinjury (mean±SD) | 37.0±58.2 | 49.6±76.5 | | | Time since injury (%) | | | | | 3–6 months | 7(21) | 7(21) | | | 6–12 months | 8(23) | 7(21) | | | 1–5 years | 12(35) | 12(35) | | | >5 years | 7(21) | 8(23) | | | Severity (%) | | | | | Severe | 17(50) | 23(68) | | | Moderate | 10(29) | 6(18) | | | Mild | 6(18) | 3(9) | | | Not available | 1(3) | 2(6) | | | Acute hospitalization (%) | 31(91) | 30(88) | | | Inpatient rehabilitation (%) | 29(85) | 26(77) | | | Outpatient rehabilitation (%) | 27(79) | 20(59) | | | Prior TBI (%) | 2(6) | 1(3) | | | Prior psychiatric illness | 3(9) | 6(18) | | | Prior substance abuse | 4(12) | 10(29) | | | | |
| | | | Measure | Treatment Main Effect | Treatment by Condition Interaction Effect | |
|---|
| F | P | F | P | ES | |
|---|
| CIQ | 1.72 | .17 | 2.89 | .042⁎ | 0.59 | | | Home | 0.67 | .42 | 0.34 | .562 | 0.08 | | | Social | 0.00 | 1.00 | 6.78 | .011⁎ | 0.46 | | | Productivity | 4.55 | .037⁎ | 2.81 | .099 | 0.46 | | | PQOL | 6.84 | .011⁎ | 4.02 | .049⁎ | 0.30 | | | NP | 7.52 | .000⁎ | 0.16 | .985 | −0.05 | | | TMT-A | 2.62 | .110 | 0.13 | .721 | 0.09 | | | TMT-B | 8.21 | .006⁎ | 0.00 | .990 | −0.06 | | | CVLT-II | 23.31 | .000⁎ | 0.37 | .546 | −0.20 | | | RCF-IR | 7.49 | .008⁎ | 0.18 | .669 | −0.10 | | | FAS | 4.19 | .045⁎ | 0.58 | .450 | −0.04 | | | CT | 24.77 | .000⁎ | 0.01 | .943 | −0.02 | | | SEsx | 3.01 | .024⁎ | 2.70 | .040⁎ | 0.26 | | | Social | 0.01 | .922 | 0.07 | .794 | 0.05 | | | Cognitive | 5.51 | .022⁎ | 1.45 | .233 | 0.20 | | | Emotional | 9.38 | .003⁎ | 7.16 | .009⁎ | 0.50 | | | | |
Primary outcomes There were no significant main effects for treatment or condition on the CIQ. There was a significant treatment by condition interaction for overall CIQ (F=2.9, P=.042) attributed to gains made by Intensive Cognitive Rehabilitation Program participants (t=3.1, P=.004) with no significant change among Standard Neurorehabilitation Program participants (ES=0.59). There was no main effect for condition on the PQOL. There was a significant main effect for treatment (F=6.9, P=.011) and a significant treatment by condition interaction (F=4.0, P=.049), which were caused by the significant improvement by the Intensive Cognitive Rehabilitation Program participants (t=3.1, P=.004), with no significant change among Standard Neurorehabilitation Program participants (ES=0.30). Analyses of treatment effects only for those participants completing the interventions and evaluations produced essentially the same results, with clinical ES of 0.61 for the total CIQ and ES of 0.30 for the PQOL. Secondary outcomes There was no main effect of condition on NP scores. There was a significant effect of treatment on NP functioning (F=7.5, P<.001) but no interaction of treatment by condition, with both Standard Neurorehabilitation Program and Intensive Cognitive Rehabilitation Program participants exhibiting significant improvements on NP functioning (ES=−0.05). The pattern of NP improvement was also similar for both groups, with significant improvements apparent on all measures except TMT-A (see table 4). The comparison of overall improvement on NP measures was similar for only those participants completing treatment and evaluation (ES=−0.09). There was no effect of condition on total self-efficacy scores. There was a significant main effect of treatment on the total self-efficacy score (F=3.2, P=.024), cognitive self-efficacy (F=5.5, P=.022), and self-efficacy for management of emotional symptoms (F=9.4, P=.003). There was a significant treatment by condition interaction for overall total self-efficacy scores (F=2.7, P=.040) (ES=0.26) and self-efficacy for the management of emotional symptoms (F=7.2, P=.009). Post hoc analyses indicated significant improvement of the Intensive Cognitive Rehabilitation Program participants on total self-efficacy scores (t=3.1, P=.004), self-efficacy for management of cognitive symptoms (cognitive self-efficacy) (t=3.0, P=.006), and self-efficacy for the management of emotional symptoms (t=4.0, P<.001), whereas no significant improvements were found after Standard Neurorehabilitation Program treatment. Analyses of participants completing treatment produced similar results, with a clinical ES of 0.29 for overall total self-efficacy scores. At the completion of treatment, 16 of 34 (47%) of Intensive Cognitive Rehabilitation Program participants were engaged in community-based employment compared with 7 of 34 (21%) of Standard Neurorehabilitation Program participants (χ2=5.32, P=.02). After excluding from analysis the 6 participants who did not complete the clinical treatment and evaluation (all of whom were considered unemployed), the comparison between treatment conditions remained significant (χ2=4.72, P=.03). Effect of time since injury Because of concerns about the influence of spontaneous recovery and time since injury on the observed outcomes, we conducted additional analyses of these relationships. We first created logical groups based on time since injury (see table 2). There was no difference between treatment conditions on the distribution of participants by time since injury (χ2=0.13, P=.99). We conducted 1-way ANOVAs comparing the time since injury groups on the difference scores from pretreatment to posttreatment for primary and secondary outcome measures. There was no effect of time since injury on overall CIQ (F=0.37, P=.78), PQOL (F=0.72, P=.54), total self-efficacy scores (F=0.98, P=.41), or NP (F=1.11, P=.35). Treatment fidelity The ratings of 12 therapists were examined by using dependent sample Wilcoxon signed-rank tests with a significance level set at P less than .003 to suggest differences between treatment conditions. The Standard Neurorehabilitation Program treatment was more strongly characterized by individual, discipline-specific therapies. The structure of the Standard Neurorehabilitation Program Treatment was considered more individualized and flexible. The Intensive Cognitive Rehabilitation Program treatment was characterized by group therapies and the integration of interventions addressing cognitive, interpersonal, and functional deficits. These results are very consistent with the design and therapeutic intent of the planned interventions. Follow up After completion of the study period, most participants (74%) required some form of follow-up treatment. Participants who completed the Standard Neurorehabilitation Program treatment were more likely to receive continued comprehensive treatment (≥3 treatment modalities a week) than those who completed the Intensive Cognitive Rehabilitation Program (70% vs 25%, χ2=10.85, P=001). The modal amount of treatment for Standard Neurorehabilitation Program participants during the follow-up period was 5 therapies (mean ± SD, 3.9±2.1), consisting of a combination of physical, occupational, speech, neuropsychology, and prevocational therapies. In contrast, 31% of Intensive Cognitive Rehabilitation Program participants did not require continued treatment, and 34% received 1 treatment modality during the poststudy follow-up period, typically prevocational counseling or neuropsychology (mode=1 therapy; mean ± SD, 1.4±1.4). We examined the maintenance of gains from poststudy treatment to follow-up with paired sample t tests within each treatment condition by using ITT analyses with the last observation carried over. Intensive Cognitive Rehabilitation Program participants maintained their gains from posttreatment to follow-up, with no significant changes on any outcome measure. Follow-up functioning remained significantly different from pretreatment for the CIQ (t=2.49, P=.018) and PQOL (t=2.38, P=.023). Although the small decline of total self-efficacy scores from posttreatment to follow-up was not a significant change (t=0.41, P=0.69), follow-up total self-efficacy scores were no longer significantly different from pretreatment (t=1.48, P=.148). Standard Neurorehabilitation Program participants showed improvement on CIQ scores from posttreatment to follow-up (t=2.09, P=.044), which could be attributed to increased productivity (t=2.54, P=.016). The change in CIQ productivity from posttreatment to follow-up was significantly correlated with number of posttreatment therapies for Standard Neurorehabilitation Program participants (Spearman ρ=0.39, P= .031) but not for Intensive Cognitive Rehabilitation Program participants (Spearman ρ=0.07). There were no changes on PQOL or total self-efficacy scores among Standard Neurorehabilitation Program participants from discharge to follow-up. Among the participants available at the time of the 6-month follow-up, 18 of 30 (60%) of Intensive Cognitive Rehabilitation Program participants were engaged in community-based employment compared with 14 of 28 (50%) of Standard Neurorehabilitation Program participants. The difference between groups was no longer significant (χ2=0.59, P=.44). ITT analysis was also not significant (χ2=2.12, P=.15). Discussion We conducted a practical clinical trial comparing comprehensive holistic NP rehabilitation with standard, multidisciplinary rehabilitation for people with TBI. Both the Intensive Cognitive Rehabilitation Program and the Standard Neurorehabilitation Program were associated with significant improvements in NP functioning. The Intensive Cognitive Rehabilitation Program produced a moderate clinical effect on community functioning and a small clinical effect on life satisfaction, neither of which were observed after Standard Neurorehabilitation Program treatment. These findings are consistent with the assumptions underlying comprehensive holistic NP rehabilitation and suggest that the Intensive Cognitive Rehabilitation Program facilitates achievement of a positive outcome through the establishment of a meaningful and satisfactory life after TBI, beyond the changes that occur through the resolution of impaired cognitive abilities. It is difficult to isolate the effective components of the Intensive Cognitive Rehabilitation Program; indeed, it is the integrated combination of interventions within the therapeutic milieu that is presumed to underlie the effectiveness of the Intensive Cognitive Rehabilitation Program. However, some discussion of the putative contributions of various components of the Intensive Cognitive Rehabilitation Program, in terms of both treatment process and structure, is warranted. Both the Intensive Cognitive Rehabilitation Program and Standard Neurorehabilitation Program included individual treatments that addressed specific cognitive abilities, which may be responsible for the improvements in NP functioning seen after both interventions. It is also possible that the improvements in NP functioning reflect more general effects of NP oriented rehabilitation, without attributing these gains to specific interventions. Specific interventions were embedded in the Intensive Cognitive Rehabilitation Program (but not the Standard Neurorehabilitation Program treatment) to promote the self-regulation of cognitive and emotional processes. The structured activity analysis emphasized the metacognitive processes of self-appraisal, prediction, self-monitoring, and self-evaluation. This process was incorporated within a variety of problem-solving activities that addressed both problem orientation and problem-solving skills. There was no attempt to avoid errors during the performance of activities; instead, it was assumed that some errors were inevitable in the course of everyday functioning, and the value of self-regulation strategies when dealing with deviations from routine situations was reinforced.39 There is evidence that error self-regulation is related to improved emergent or online awareness and effective use of compensatory strategies in functional situations.40, 41, 42 Self-monitoring and regulation of emotional processes were also embedded in Intensive Cognitive Rehabilitation Program treatment through the use of the Cognitive Energy Scale. The Cognitive Energy Scale provided participants with a means of periodically monitoring their emotional state, level of alertness, and ability to effectively engage in activities. The Cognitive Energy Scale appears to be an internal self-regulatory strategy that is both easy to use and highly portable. Both the activity analysis and the Cognitive Energy Scale were regularly incorporated in homework assignments to promote the use of self-monitoring and self-evaluation strategies during participants' everyday activities. The structure of the Intensive Cognitive Rehabilitation Program allowed us to obtain narrative reports from those participants and family members over the course of treatment; these narratives indicated that both the activity analysis and the Cognitive Energy Scale were believed to be effective and were spontaneously carried over from the treatment setting to participants' daily functioning. These findings suggest that metacognition and emotional regulation may represent effective components of comprehensive holistic NP rehabilitation, which is consistent with increasing evidence for the benefit of training self regulatory strategies after TBI.24, 43, 44, 45 Specific interventions within the Intensive Cognitive Rehabilitation Program were based on principles for improving perceived self-efficacy.22, 23 The improvements in perceived self-efficacy for the management of cognitive and emotional symptoms after the Intensive Cognitive Rehabilitation Program support our prior suggestion that treatment should address participants' self-perceptions and beliefs in order to be effective.19 These findings are consistent with the evidence that problem-solving therapies are more effective when they include training in problem orientation in addition to training for problem-solving skills.24, 25, 46 The improvements in self-efficacy after the Intensive Cognitive Rehabilitation Program are consistent with evidence that perceived competence is predictive of level of functioning.32, 47 The Intensive Cognitive Rehabilitation Program and Standard Neurorehabilitation Program treatment conditions differed in their structure and treatment orientation. The Standard Neurorehabilitation Program treatment was provided primarily through individual, discipline-specific therapies directed at the remediation of functional impairments or discrete cognitive deficits. The structure of the Intensive Cognitive Rehabilitation Program emphasized group treatments for cognitive, social communication, and functional abilities. Previous studies24, 48, 49 have also shown the benefits of group treatment in the rehabilitation of TBI. In addition to the specific content of group treatments, Intensive Cognitive Rehabilitation Program groups emphasized peer feedback and support and reinforced the transfer of compensatory strategies across interventions. The Intensive Cognitive Rehabilitation Program emphasized the integration of cognitive, emotional, and interpersonal issues and was oriented toward helping participants adapt to their disability despite persisting limitations. Narrative reports from participants noted the value of peer support and cohesion fostered by group participation as well as the belief that all of the therapists involved in their treatment shared a common understanding of their difficulties and supported their expectations for improved functioning in their lives. These observations suggest that group cohesion and therapeutic alliance contributed to the effectiveness of the Intensive Cognitive Rehabilitation Program. Although these are common to many forms of treatment, we suggest that these facilitative experiences are directly encouraged and heightened through the therapeutic milieu of comprehensive holistic NP rehabilitation. Participants in the Intensive Cognitive Rehabilitation Program and Standard Neurorehabilitation Program conditions received the same intensity and duration of treatment, and the same therapists provided the treatment in both conditions. It is unlikely that these nonspecific factors can account for the differences in treatment effectiveness between conditions. The improvements in community functioning, self-efficacy for management of cognitive and emotional symptoms, and life satisfaction observed after the Intensive Cognitive Rehabilitation Program were maintained at the time of follow-up 6 months after the completion of treatment. The improvements in perceived self-efficacy did show a slight decline from discharge to follow-up, which, although not significantly different, suggests that these gains may be most apparent during active participation in rehabilitation.50 The gains in community integration and life satisfaction appear to be stable and enduring benefits of the Intensive Cognitive Rehabilitation Program, at least for the observed follow-up period. Participants in the Standard Neurorehabilitation Program rehabilitation showed continued gains in community integration and productivity from discharge to follow-up, suggesting a more prolonged course of improvement. Standard Neurorehabilitation Program participants were also more likely to require continued comprehensive rehabilitation during the 6 months after the study period. Thus, the increased productivity for Standard Neurorehabilitation Program participants is associated with the need for more extensive rehabilitation, and Standard Neurorehabilitation Program participants still did not achieve the gains in psychological well-being shown by Intensive Cognitive Rehabilitation Program participants. The results of the study might best be appreciated as a slice of rehabilitation. Over two thirds of the participants were enrolled in the study as part of a continuous course of TBI rehabilitation, and 74% received some form of follow-up treatment. These findings indicate that the Intensive Cognitive Rehabilitation Program can be a clinically beneficial intervention when implemented in the course of naturally occurring recovery and rehabilitation.20 More than half of the participants were over 1 year postinjury at the time of enrollment, about 40% were over 2 years postinjury, and 22% were over 5 years postinjury, suggesting that the benefits of NP rehabilitation can be apparent for people with TBI even years after their injury.11, 19 Study Limitations Given the complexity of both interventions, we cannot reliably identify the contributions of specific components of treatment. Additional research investigating the effectiveness of specific treatment components and mechanisms of change is warranted. Because of the relatively small sample size, we did not conduct subgroup analyses of the interaction of patient characteristics with treatment conditions. Additional research is required to investigate who benefits from different forms of treatment. This will require large samples to detect the variations among different patient characteristics under different treatment conditions on different types of outcomes, which are likely to be complex. The difficulty of blinding patients and therapists to treatment conditions is inherent to complex rehabilitation trials. In the present study, participants and therapists had knowledge that both treatments were clinically established programs that were expected to be beneficial, with no assumption regarding differential benefits and no further information about the specific intent of the study. We do not believe that any subtle expectancies or biases, if they existed, can account for the results of the study. The primary outcomes in the study relied on participant self-report, which may have influenced the results. NP functioning, based on objective masked evaluations, showed equal improvement under both treatment conditions. The validity of the CIQ findings are supported by indications that self-reports and significant other reports on the CIQ show good agreement51 and the independent observation of greater rates of community-based employment for Intensive Cognitive Rehabilitation Program participants. The self-appraisal of life satisfaction is inherently germane to the assessment of subjective well-being.5, 52 The validity of these improvements is further supported by their maintenance at follow-up. Conclusions We have now shown the effectiveness of comprehensive holistic NP rehabilitation in a clinical observational study19 and a randomized clinical trial. When compared with standard neurorehabilitation, people with TBI who receive comprehensive holistic NP rehabilitation show improved confidence in their ability to manage their cognitive and emotional symptoms, which may be related to the emphases on self-regulation of cognitive and emotional processes as a central component of treatment. Our results support the contention that comprehensive rehabilitation for people with TBI should provide integrated treatment of cognitive, emotional, interpersonal, and functional skills and show that this form of comprehensive holistic NP rehabilitation improves community functioning and quality of life after TBI. Supplier Acknowledgment We gratefully acknowledge the therapists who contributed their clinical time to provide treatment in accordance with the research protocols. References 1. 1Malec JF, Basford JS. Postacute brain injury rehabilitation. Arch Phys Med Rehabil. 1996;77:198–207. Abstract |
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a Department of Cognitive Rehabilitation, JFK-Johnson Rehabilitation Institute, Edison, NJ b Department of Physical Medicine and Rehabilitation, JFK-Johnson Rehabilitation Institute, Edison, NJ  Reprint requests to Keith D. Cicerone, PhD, 2048 Oak Tree Rd, Edison, NJ 08820
Supported by the National Institute on Disability and Rehabilitation Research (grant no. H133A020518). No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. PII: S0003-9993(08)01490-1 doi:10.1016/j.apmr.2008.06.017 © 2008 American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved. | |
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