2239
ORIGINAL ARTICLE
A Randomized Controlled Trial of Holistic Neuropsychologic
Rehabilitation After Traumatic Brain Injury
Keith D. Cicerone, PhD, Tasha Mott, PhD, Joanne Azulay, PhD, Mary A. Sharlow-Galella, LCSW,
Wendy J. Ellmo, MS, CCC-SLP, Susan Paradise, MEd, John C. Friel, PhD
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. Arch Phys Med Rehabil 2008;89:
2239-49.
Objective: To evaluate the effectiveness of comprehensive,
holistic neuropsychologic (NP) rehabilitation compared with
standard, multidisciplinary rehabilitation for people with trau-
matic brain injury (TBI).
Design: Randomized practical controlled trial.
Setting: Postacute brain injury rehabilitation center within a
suburban rehabilitation hospital.
Participants: Participants with TBI were recruited from
clinical referrals and referrals from the community. Sixty-eight
participants who met inclusion criteria were randomly allo-
cated 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.
Interventions: Treatment 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 cogni-
tive, interpersonal, and functional interventions within a ther-
apeutic environment (n⫽34).
Main Outcome Measures: Primary 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.
Results: NP functioning improved in both conditions. Inten-
sive cognitive rehabilitation participants showed greater im-
provements on the CIQ (effect size [ES]⫽0.59) and PQOL
(ES⫽0.30) as well as improved self-efficacy for the manage-
ment of symptoms (ES⫽0.26) compared with standard neuro-
rehabilitation treatment. These gains were maintained at the
6-month follow-up. Standard neurorehabilitation participants
showed improved productivity at the 6-month follow-up asso-
ciated with the need for continued rehabilitation.
Conclusions: Improvements seen after intensive cognitive
rehabilitation may be related to interventions directed at the
self-regulation of cognitive and emotional processes and the
From the Departments of Cognitive Rehabilitation (Cicerone, Mott, Azulay, Shar-
low-Galella, Ellmo, Paradise, Friel) and Physical Medicine and Rehabilitation (Ci-
cerone), JFK-Johnson Rehabilitation Institute, Edison, NJ.
Presented preliminary results at the Annual Meeting of the American Congress of
Rehabilitation Medicine, October 9, 2007, Washington DC.
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 organi-
zation with which the authors are associated.
Reprint requests to Keith D. Cicerone, PhD, 2048 Oak Tree Rd, Edison, NJ 08820,
e-mail: kcicerone@solarishs.org.
0003-9993/08/8912-00344$34.00/0
doi:10.1016/j.apmr.2008.06.017
integrated treatment of cognitive, interpersonal, and functional
skills. The results show the effectiveness of comprehensive
holistic NP rehabilitation for improving community function-
ing and quality of life after TBI compared with standard
rehabilitation.
Key Words: Brain injuries; Quality of life; Rehabilitation.
© 2008 by the American Congress of Rehabilitation Medi-
cine and the American Academy of Physical Medicine and
Rehabilitation
ABIR REQUIRES A COMPREHENSIVE approach to
P 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 special-
ized programs, including multidisciplinary, outpatient treat-
ment, 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 ad-
dressing 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 compre-
hensive 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 productiv-
ity6-10 by patients 1 or more years after TBI,11 with gains
maintained for several years after rehabilitation.12,13 Prospec-
tive observational studies support the effectiveness of compre-
hensive holistic NP rehabilitation compared with no-treat-
ment14 or conventional rehabilitation.15
Randomized controlled studies of comprehensive holistic
NP rehabilitation16-18 have shown more limited evidence of
effectiveness, although these studies have significant method-
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
Arch Phys Med Rehabil Vol 89, December 2008
2240 RANDOMIZED CONTROLLED TRIAL OF NEUROPSYCHOLOGIC REHABILITATION, Cicerone
ologic limitations. Ruff et al16,17 recruited volunteer partici-
pants from the community who were motivated to participate in
treatment. Computer-based treatment of specific cognitive abil-
ities 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 interven-
tions.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. Nei-
ther of these studies used a clinically representative sample of
patients receiving PABIR, and neither program was fully rep-
resentative of comprehensive holistic NP rehabilitation com-
pared with a clinically viable intervention.
We previously conducted an observational study comparing
comprehensive holistic cognitive rehabilitation (the Intensive
Cognitive Rehabilitation Program) with standard multidisci-
plinary, 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 integra-
tion. There was a bias in assigning patients to treatment alterna-
tives, which resulted in the intensive cognitive rehabilitation pro-
gram 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 par-
ticipants’ 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 Reha-
bilitation Program and the Standard Neurorehabilitation Pro-
gram 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 treat-
ments to produce improvements in NP functioning, without
predicting any difference between treatment conditions. Al-
though we did not expect differences in NP functioning be-
tween programs, we hypothesized that the Intensive Cognitive
Rehabilitation Program would be associated with greater im-
provements 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 reha-
bilitation hospital in the northeastern United States. Criteria for
admission to the rehabilitation program were (1) medical sta-
bility, (2) independence in basic self-care (eg, feeding, toilet-
Arch Phys Med Rehabil Vol 89, December 2008
ing), 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. Commu-
nity-referred participants had not received rehabilitation ther-
apies 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 de-
vice) 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 ei-
ther 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 psy-
chiatric illness, substance abuse, or pain considered at the time
of enrollment to prevent their compliance with treatment. Pa-
tients 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 inter-
active statistical calculation pages (www.statpages.org) to al-
locate 48 participants per condition. Randomization occurred
in unequal, blocked multiples of 4 to optimize equal assign-
ment 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 enve-
lopes. 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 Institu-
tional 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 pa-
tients 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
 RANDOMIZED CONTROLLED TRIAL OF NEUROPSYCHOLOGIC REHABILITATION, Cicerone
Fig 1. The flow of participants through the study.
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 out-
patient 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
2241
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 in-
jury, and we were unable to determine severity for 4 partici-
pants (3%). There were no differences between treatment con-
ditions on any of these characteristics. The groups were
equivalent on all outcome measures before treatment.
Two participants withdrew from Intensive Cognitive Reha-
bilitation Program treatment: 1 within the first week of treat-
ment and 1 subsequent to an episode of psychiatric symptom-
atology and substance abuse. Four participants withdrew from
the Standard Neurorehabilitation Program treatment: 1 did not
complete treatment because of psychiatric hospitalization, and
Arch Phys Med Rehabil Vol 89, December 2008
2242 RANDOMIZED CONTROLLED TRIAL OF NEUROPSYCHOLOGIC REHABILITATION, Cicerone
3 completed the planned treatment but refused posttreatment
evaluations in association with increased psychiatric symp-
toms. An additional 4 participants did not respond to requests
for 6-month follow-up evaluation: 2 from the Intensive Cog-
nitive Rehabilitation Program and 2 from the Standard Neuro-
rehabilitation Program.
Interventions
Both the Intensive Cognitive Rehabilitation Program and the
Standard Neurorehabilitation Program consisted of clinically es-
tablished treatment programs that were based on principles of
NP rehabilitation2 but differed in their treatment orientation
and program structure. Both treatments were conducted simul-
taneously within the same postacute rehabilitation program,
with the same therapists providing treatment in both condi-
tions. 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 infor-
mation 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 contin-
ued their existing medical care and were allowed to continue
psychologic counseling or psychotherapy but were not receiv-
ing other therapies. Treatments in both treatment arms were
individualized according to participants’ clinical needs to the
extent possible. Participants in the Standard Neurorehabilita-
tion 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 as-
sessed at the end of the study with a scale of treatment orien-
tation 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 Cog-
nitive Rehabilitation Program and Standard Neurorehabilita-
tion Program treatments.
Intensive Cognitive Rehabilitation Program. The treat-
ment orientation of the Intensive Cognitive Rehabilitation Pro-
gram was based on principles of comprehensive holistic NP
rehabilitation3,5 emphasizing the integration of interventions
for cognitive deficits, emotional difficulties, interpersonal be-
haviors, 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. Treat-
ment 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 interven-
tions emphasized metacognition (self-monitoring and self-reg-
ulation) and emotional regulation. These processes were re-
inforced through 2 interventions specific to the Intensive
Cognitive Rehabilitation Program condition that were embed-
ded within all therapy sessions and homework assignments. A
structured activity analysis was based on the cognitive deter-
minants of self-efficacy22,23: (1) identification and analysis of
the specific requirements of the task, (2) personal attributes that
Arch Phys Med Rehabil Vol 89, December 2008
might influence performance (eg, cognitive strengths and lim-
itations, emotional reactions, interests, and motivation), (3)
situational factors that might influence performance (eg, com-
peting demands, time limits, social supports), and (4) predict-
ing their confidence and likelihood of success in carrying out
the activity. Emotional monitoring and regulation were facili-
tated 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 descrip-
tors 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 en-
gage 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 extemporane-
ously, to monitor their emotional status and implement self-
regulatory strategies. Interventions were designed to incorpo-
rate 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 strat-
egies 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. Treat-
ment exercises focused on task analysis, planning and organi-
zation, goal setting, and social problem solving. There was an
emphasis on relating the problems and compensations experi-
enced within treatment sessions to similar situations in partic-
ipants’ daily activities. Weeks 9 through 12 focused on the
independent application and carryover of compensatory strat-
egies, 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 thera-
pies conducted 3 days a week. All Intensive Cognitive Reha-
bilitation 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 treat-
ment 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 anal-
ysis 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 home-
work exercises.
Intensive Cognitive Rehabilitation Program participants re-
ceived 3 hours of individual therapy from a primary therapist.
 RANDOMIZED CONTROLLED TRIAL OF NEUROPSYCHOLOGIC REHABILITATION, Cicerone
Primary therapy sessions typically provided cognitive remedia-
tion, relating individual cognitive interventions to group treat-
ments and making explicit the relation between the partici-
pant’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 re-
ceived 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 retrain-
ing of discrete cognitive functions, and conducted primarily
through individual therapies. The structure of Standard Neuro-
rehabilitation Program treatment consisted of individual ther-
apies including physical therapy, occupational therapy, and
speech therapy. All patients were followed by a neuropsychol-
ogist, and most participants received 1 hour a week of individ-
ual NP treatment. NP treatment in the Standard Neurorehabili-
tation 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 Neurore-
habilitation Program treatment could receive a limited number
of group treatments (ⱕ3h/wk). The amount and combination of
specific treatments for each participant in the Standard Neuro-
rehabilitation 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, per-
ceived self-efficacy, and vocational activity. Outcome mea-
sures were administered within the 2 weeks before commenc-
ing 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 struc-
ture of the CIQ and identified 3 factors reflecting home com-
petency, social integration, and productive activity. Sander28
modified the scoring procedure to correspond with their em-
pirically derived factors; these recommendations were fol-
lowed 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 inten-
2243
sive 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 indi-
vidual 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, com-
munity participation and leisure, work and income, and mean-
ing 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
␣⫽.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 imme-
diate recall score for the Rey Complex Figure.35 Higher cog-
nitive 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 neuropsy-
chologist 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 devel-
oped 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 re-
sponses 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 ␣⫽.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-effi-
cacy cognitive), and 4 items assessing self-management of
emotional symptoms (self-efficacy emotional); the single re-
maining item assessing self-management for physical symp-
toms was not analyzed separately but was included in the total
score.
Community-based employment. Vocational and educa-
tional 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 employ-
ment (ie, job coaching or other permanent supports), (4) tran-
sitional employment (education, job coaching, or other tempo-
rary supports), and (5) competitive employment. We collapsed
ratings to a dichotomous variable to classify participants as
engaged in community-based employment (Vocational Integra-
Arch Phys Med Rehabil Vol 89, December 2008
2244 RANDOMIZED CONTROLLED TRIAL OF NEUROPSYCHOLOGIC REHABILITATION, Cicerone

tion Scale levels 3–5) or unemployed (Vocational Integration Table 2: Injury-Related Characteristics of Participants
Scale levels 1–2), consistent with prior use of this measure.9 Characteristic STD ICRP

Statistical Analyses N 34 34
The effects of treatment were analyzed by using multivari- Months postinjury (mean⫾SD) 37.0⫾58.2 49.6⫾76.5
ate, repeated-measures ANOVA (SPSS version 14)a to inves- Time since injury (%)
tigate changes from the pretreatment to posttreatment (treat- 3–6 months 7 (21) 7 (21)
ment effect) and compare between the Intensive Cognitive 6–12 months 8 (23) 7 (21)
Rehabilitation Program and Standard Neurorehabilitation Pro- 1–5 years 12 (35) 12 (35)
gram intervention (condition). ITT analyses were conducted by ⬎5 years 7 (21) 8 (23)
carrying forward the pretreatment baseline scores for the 6 Severity (%)
participants who failed to complete their respective treatment Severe 17 (50) 23 (68)
protocol and/or posttreatment outcome measures. Post hoc Moderate 10 (29) 6 (18)
analyses were conducted only after a variable had shown Mild 6 (18) 3 (9)
significance on the planned multivariate ANOVA by using Not available 1 (3) 2 (6)
within-group paired-sample t tests to determine the source of Acute hospitalization (%) 31 (91) 30 (88)
significance. We examined treatment interaction ES for differ- Inpatient rehabilitation (%) 29 (85) 26 (77)
ences between groups from pretreatment to posttreatment by Outpatient rehabilitation (%) 27 (79) 20 (59)
using a variant of Hedge’s g for the comparison of independent Prior TBI (%) 2 (6) 1 (3)
group prepost-treatment scores that accounts for differences in Prior psychiatric illness 3 (9) 6 (18)
pretreatment variance between groups38 ([mean intensive cog- Prior substance abuse 4 (12) 10 (29)
nitive rehabilitation programposttreatment ⫺ mean intensive cog- Abbreviations: ICRP, Intensive Cognitive Rehabilitation Program;
nitive rehabilitation programpretreatment/SD intensive cognitive STD, Standard Neurorehabilitation Program.
rehabilitation programpre-treatment] ⫺ [mean standard neurore-
habilitation programposttreatment ⫺ mean standard neurorehabili-
tation programpretreatment/SD standard neurorehabilitation pro-
grampretreatment]). Primary outcomes. There were no significant main effects
for treatment or condition on the CIQ. There was a significant
RESULTS treatment by condition interaction for overall CIQ (F⫽2.9,
There were no differences between conditions on demo- P⫽.042) attributed to gains made by Intensive Cognitive Re-
graphic characteristics (table 1), injury-related characteristics habilitation Program participants (t⫽3.1, P⫽.004) with no
(table 2), or pretreatment measures (tables 3, 4). Tables 3 and significant change among Standard Neurorehabilitation Pro-
4 depict the descriptive statistics for the ITT analyses at pre- gram participants (ES⫽0.59).
treatment baseline, posttreatment outcome, and 6 month follow There was no main effect for condition on the PQOL. There
up. (Descriptive statistics for participants completing treatment was a significant main effect for treatment (F⫽6.9, P⫽.011)
and follow-up are available from the first author.) Table 5 and a significant treatment by condition interaction (F⫽4.0,
presents inferential statistics for the ITT analyses. 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).
Table 1: Demographic Characteristics of Participants
Analyses of treatment effects only for those participants
Characteristic STD ICRP completing the interventions and evaluations produced essen-
tially the same results, with clinical ES of 0.61 for the total CIQ
N 34 34
and ES of 0.30 for the PQOL.
Age (y) (mean⫾SD) 34.5⫾12.4 38.7⫾11.1
Secondary outcomes. There was no main effect of condi-
Education (y) (mean⫾SD) 12.5⫾1.2 13.2⫾1.9
tion on NP scores. There was a significant effect of treatment
Sex (%)
on NP functioning (F⫽7.5, P⬍.001) but no interaction of
Men 21 (62) 25 (74)
treatment by condition, with both Standard Neurorehabilitation
Women 13 (38) 9 (27)
Program and Intensive Cognitive Rehabilitation Program par-
Race (%)
ticipants exhibiting significant improvements on NP function-
White 24 (71) 27 (79)
ing (ES⫽⫺0.05). The pattern of NP improvement was also
Black 4 (12) 3 (9)
similar for both groups, with significant improvements appar-
Hispanic 5 (15) 3 (9)
ent on all measures except TMT-A (see table 4). The compar-
Asian 1 (3) 1 (3)
ison of overall improvement on NP measures was similar for
Marital status (%)
only those participants completing treatment and evaluation
Single 18 (53) 17 (50)
(ES⫽⫺0.09).
Married 11 (32) 13 (38)
There was no effect of condition on total self-efficacy scores.
Divorced/separated/widowed 5 (15) 4 (12)
There was a significant main effect of treatment on the total
Employment preinjury (%)
self-efficacy score (F⫽3.2, P⫽.024), cognitive self-efficacy
Employed 27 (80) 27 (80)
(F⫽5.5, P⫽.022), and self-efficacy for management of emo-
Unemployed 2 (6) 1 (3)
tional symptoms (F⫽9.4, P⫽.003). There was a significant
Homemaker 1 (3) 0 (0)
treatment by condition interaction for overall total self-efficacy
Student 3 (9) 6 (18)
scores (F⫽2.7, P⫽.040) (ES⫽0.26) and self-efficacy for the
Retired 1 (3) 0 (0)
management of emotional symptoms (F⫽7.2, P⫽.009). Post
Abbreviations: ICRP, Intensive Cognitive Rehabilitation Program; hoc analyses indicated significant improvement of the Intensive
STD, Standard Neurorehabilitation Program. Cognitive Rehabilitation Program participants on total self-

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Table 3: Primary Outcome Measures

STD (n⫽34) ICRP (n⫽34)

Pretreatment Posttreatment Follow-Up Pretreatment Posttreatment Follow-Up

CIQ total 12.1⫾4.0 11.7⫾4.4 12.9⫾4.4 11.2⫾3.4 12.9⫾3.4* 13.2⫾4.3*

Home competency 4.0⫾2.4 4.1⫾2.7 4.1⫾2.6 3.8⫾2.5 4.1⫾1.7 4.3⫾2.0
Social integration 7.3⫾2.2 6.7⫾2.2 7.1⫾1.9 6.4⫾2.2 7.0⫾1.9 6.9⫾2.2
Productivity 0.9⫾1.5 1.0⫾1.5 1.6⫾1.8* 1.0⫾1.5* 1.8⫾1.6* 2.0⫾1.5*
PQOL 61.2⫾16.5 62.2⫾17.2 59.6⫾17.2 59.0⫾21.7 66.8⫾17.5* 66.1⫾20.8*

NOTE. Means and SD for ITT analyses.

Abbreviations: ICRP, Intensive Cognitive Rehabilitation Program; STD, Standard Neurorehabilitation Program.
*Significant difference from pretreatment, P⬍.05.

efficacy scores (t⫽3.1, P⫽.004), self-efficacy for manage-
ment 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 treat-
ment 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 (␹2⫽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 (␹2⫽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 (␹2⫽0.13, P⫽.99). We conducted 1-way
ANOVAs comparing the time since injury groups on the dif-
ference 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 ex-
amined 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 Neu-
rorehabilitation Program treatment was more strongly charac-
terized by individual, discipline-specific therapies. The struc-
ture 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 address-
ing cognitive, interpersonal, and functional deficits. These re-
sults 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 Neurorehabilita-
tion Program treatment were more likely to receive continued
comprehensive treatment (ⱖ3 treatment modalities a week)
than those who completed the Intensive Cognitive Rehabilita-
tion Program (70% vs 25%, ␹2⫽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,

Table 4: Secondary Outcome Measures

STD (n⫽34) ICRP (n⫽34)

Pretreatment Posttreatment Follow-Up Pretreatment Posttreatment Follow-Up

Neuropsychologic T scores
Mean NP 35.9⫾9.0 39.5⫾9.6* — 36.6⫾8.5 39.5⫾9.1* —
TMT-A 34.9⫾13.2 36.9⫾12.8 — 32.2⫾12.9 33.5⫾12.7 —
TMT-B 33.3⫾11.4 36.7⫾13.7* — 33.0⫾14.1 36.4⫾10.7* —
CVLT-II 38.6⫾11.7 44.2⫾14.3* — 42.1⫾15.1 46.4⫾15.6* —
RCF-IR 32.5⫾12.7 35.9⫾14.6* — 35.8⫾15.1 38.3⫾15.5* —
Verbal fluency 37.2⫾12.3 39.3⫾11.3* — 38.8⫾7.1 39.7⫾9.1* —
Category test 39.1⫾13.8 44.3⫾18.2* — 37.9⫾14.3 43.0⫾15.8* —
SEsx total 82.6⫾27.9 84.8⫾28.9 81.9⫾30.0 84.3⫾28.9 94.1⫾29.2* 92.4⫾22.7
Social 27.6⫾8.9 27.4⫾8.2 27.4⫾9.4 27.8⫾9.1 28.1⫾7.1 29.4⫾7.6
Cognitive 24.5⫾9.4 25.6⫾7.5 24.8⫾9.9 25.5⫾10.7 28.9⫾8.7* 27.6⫾7.8
Emotional 24.9⫾10.4 25.3⫾9.4 24.2⫾11.0 24.4⫾10.5 30.1⫾8.4* 27.9⫾8.1
Vocational [N (%)]
Productive 4 (12%) 7 (21%) 14 (41%) 3 (9%) 16 (47%) 20 (59%)
Nonproductive 30 (88%) 27 (79%) 20 (59%) 31 (91%) 18 (53%) 14 (41%)

NOTE. Means and SD for intent-to-treat analyses.

Abbreviations: CVLT-II, California Verbal Learning Test II; ICRP, Intensive Cognitive Rehabilitation Program; RCF-IR, Rey Complex Figure,
Immediate Recall; SEsx, Self Efficacy for Management of Symptoms Scale; STD, Standard Neurorehabilitation Program.
*Significant difference from pretreatment, P⬍.05.

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Table 5: Inferential Statistics for ITT Analyses of Primary and DISCUSSION

Secondary Outcomes
We conducted a practical clinical trial comparing compre-
Treatment Main Treatment by Condition hensive holistic NP rehabilitation with standard, multidisci-
Effect Interaction Effect
plinary rehabilitation for people with TBI. Both the Intensive
Measure F P F P ES Cognitive Rehabilitation Program and the Standard Neurore-
CIQ 1.72 .17 2.89 .042* 0.59 habilitation Program were associated with significant improve-
Home 0.67 .42 0.34 .562 0.08 ments in NP functioning. The Intensive Cognitive Rehabilitation
Social 0.00 1.00 6.78 .011* 0.46 Program produced a moderate clinical effect on community
Productivity 4.55 .037* 2.81 .099 0.46 functioning and a small clinical effect on life satisfaction,
PQOL 6.84 .011* 4.02 .049* 0.30 neither of which were observed after Standard Neurorehabili-
NP 7.52 .000* 0.16 .985 ⫺0.05 tation Program treatment. These findings are consistent with
TMT-A 2.62 .110 0.13 .721 0.09 the assumptions underlying comprehensive holistic NP reha-
TMT-B 8.21 .006* 0.00 .990 ⫺0.06 bilitation and suggest that the Intensive Cognitive Rehabilita-
CVLT-II 23.31 .000* 0.37 .546 ⫺0.20 tion Program facilitates achievement of a positive outcome
RCF-IR 7.49 .008* 0.18 .669 ⫺0.10 through the establishment of a meaningful and satisfactory life
FAS 4.19 .045* 0.58 .450 ⫺0.04 after TBI, beyond the changes that occur through the resolution
CT 24.77 .000* 0.01 .943 ⫺0.02 of impaired cognitive abilities.
SEsx 3.01 .024* 2.70 .040* 0.26 It is difficult to isolate the effective components of the
Social 0.01 .922 0.07 .794 0.05 Intensive Cognitive Rehabilitation Program; indeed, it is the
Cognitive 5.51 .022* 1.45 .233 0.20 integrated combination of interventions within the therapeutic
Emotional 9.38 .003* 7.16 .009* 0.50 milieu that is presumed to underlie the effectiveness of the
NOTE. See text for method of calculation for ES.
Intensive Cognitive Rehabilitation Program. However, some
Abbreviations: ICRP, Intensive Cognitive Rehabilitation Program; discussion of the putative contributions of various components
SEsx, Self Efficacy for Management of Symptoms scale; STD, Stan- of the Intensive Cognitive Rehabilitation Program, in terms of
dard Neurorehabilitation Program. both treatment process and structure, is warranted. Both the
*Significant effects.
Intensive Cognitive Rehabilitation Program and Standard Neu-
rorehabilitation Program included individual treatments that
occupational, speech, neuropsychology, and prevocational addressed specific cognitive abilities, which may be responsi-
therapies. In contrast, 31% of Intensive Cognitive Rehabilita- ble for the improvements in NP functioning seen after both
tion Program participants did not require continued treatment, interventions. It is also possible that the improvements in NP
and 34% received 1 treatment modality during the poststudy functioning reflect more general effects of NP oriented reha-
follow-up period, typically prevocational counseling or neuro- bilitation, without attributing these gains to specific interven-
psychology (mode⫽1 therapy; mean ⫾ SD, 1.4⫾1.4). tions.
We examined the maintenance of gains from poststudy treat- Specific interventions were embedded in the Intensive Cogni-
ment to follow-up with paired sample t tests within each tive Rehabilitation Program (but not the Standard Neurorehabili-
treatment condition by using ITT analyses with the last obser- tation Program treatment) to promote the self-regulation of cog-
vation carried over. Intensive Cognitive Rehabilitation Pro- nitive and emotional processes. The structured activity analysis
gram participants maintained their gains from posttreatment to emphasized the metacognitive processes of self-appraisal, pre-
follow-up, with no significant changes on any outcome mea- diction, self-monitoring, and self-evaluation. This process was
sure. Follow-up functioning remained significantly different incorporated within a variety of problem-solving activities that
from pretreatment for the CIQ (t⫽2.49, P⫽.018) and PQOL addressed both problem orientation and problem-solving skills.
(t⫽2.38, P⫽.023). Although the small decline of total self- There was no attempt to avoid errors during the performance of
efficacy scores from posttreatment to follow-up was not a activities; instead, it was assumed that some errors were inev-
significant change (t⫽0.41, P⫽0.69), follow-up total self-effi- itable in the course of everyday functioning, and the value of
cacy scores were no longer significantly different from pre- self-regulation strategies when dealing with deviations from
treatment (t⫽1.48, P⫽.148). routine situations was reinforced.39 There is evidence that error
Standard Neurorehabilitation Program participants showed self-regulation is related to improved emergent or online
improvement on CIQ scores from posttreatment to follow-up awareness and effective use of compensatory strategies in
(t⫽2.09, P⫽.044), which could be attributed to increased pro- functional situations.40-42 Self-monitoring and regulation of
ductivity (t⫽2.54, P⫽.016). The change in CIQ productivity emotional processes were also embedded in Intensive Cogni-
from posttreatment to follow-up was significantly correlated tive Rehabilitation Program treatment through the use of the
with number of posttreatment therapies for Standard Neurore- Cognitive Energy Scale. The Cognitive Energy Scale provided
habilitation Program participants (Spearman ␳⫽0.39, P⫽ .031) participants with a means of periodically monitoring their
but not for Intensive Cognitive Rehabilitation Program partic- emotional state, level of alertness, and ability to effectively
ipants (Spearman ␳⫽0.07). engage in activities. The Cognitive Energy Scale appears to be
There were no changes on PQOL or total self-efficacy scores an internal self-regulatory strategy that is both easy to use and
among Standard Neurorehabilitation Program participants from highly portable. Both the activity analysis and the Cognitive
discharge to follow-up. Energy Scale were regularly incorporated in homework assign-
Among the participants available at the time of the 6-month ments to promote the use of self-monitoring and self-evaluation
follow-up, 18 of 30 (60%) of Intensive Cognitive Rehabilita- strategies during participants’ everyday activities. The struc-
tion Program participants were engaged in community-based ture of the Intensive Cognitive Rehabilitation Program allowed
employment compared with 14 of 28 (50%) of Standard Neu- us to obtain narrative reports from those participants and family
rorehabilitation Program participants. The difference between members over the course of treatment; these narratives indi-
groups was no longer significant (␹2⫽0.59, P⫽.44). ITT anal- cated that both the activity analysis and the Cognitive Energy
ysis was also not significant (␹2⫽2.12, P⫽.15). Scale were believed to be effective and were spontaneously

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 RANDOMIZED CONTROLLED TRIAL OF NEUROPSYCHOLOGIC REHABILITATION, Cicerone
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 regu-
latory strategies after TBI.24,43-45
Specific interventions within the Intensive Cognitive Reha-
bilitation 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 effec-
tive.19 These findings are consistent with the evidence that
problem-solving therapies are more effective when they in-
clude training in problem orientation in addition to training for
problem-solving skills.24,25,46 The improvements in self-effi-
cacy after the Intensive Cognitive Rehabilitation Program are
consistent with evidence that perceived competence is predic-
tive of level of functioning.32,47
The Intensive Cognitive Rehabilitation Program and Stan-
dard Neurorehabilitation Program treatment conditions differed
in their structure and treatment orientation. The Standard Neu-
rorehabilitation 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 stud-
ies24,48,49 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 reinfor-
ced 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 expecta-
tions for improved functioning in their lives. These observa-
tions 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 experi-
ences are directly encouraged and heightened through the ther-
apeutic milieu of comprehensive holistic NP rehabilitation.
Participants in the Intensive Cognitive Rehabilitation Pro-
gram 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 Rehabilita-
tion 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 dis-
charge to follow-up, which, although not significantly differ-
ent, 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 endur-
ing benefits of the Intensive Cognitive Rehabilitation Program,
2247
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 com-
prehensive rehabilitation during the 6 months after the study
period. Thus, the increased productivity for Standard Neurore-
habilitation Program participants is associated with the need for
more extensive rehabilitation, and Standard Neurorehabilita-
tion Program participants still did not achieve the gains in
psychological well-being shown by Intensive Cognitive Reha-
bilitation 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 treat-
ment. These findings indicate that the Intensive Cognitive
Rehabilitation Program can be a clinically beneficial interven-
tion 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 reli-
ably identify the contributions of specific components of treat-
ment. 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 varia-
tions 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 ex-
pected 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 func-
tioning, 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 agree-
ment51 and the independent observation of greater rates of
community-based employment for Intensive Cognitive Reha-
bilitation Program participants. The self-appraisal of life satis-
faction 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 comprehen-
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2248 RANDOMIZED CONTROLLED TRIAL OF NEUROPSYCHOLOGIC REHABILITATION, Cicerone
sive holistic NP rehabilitation show improved confidence in
their ability to manage their cognitive and emotional symp-
toms, 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 comprehen-
sive rehabilitation for people with TBI should provide inte-
grated 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.
Acknowledgment: We gratefully acknowledge the therapists
who contributed their clinical time to provide treatment in accordance
with the research protocols.
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