Using a brief intervention to improve decisional capacity in schizophrenia research

Studies have shown that individuals with psychiatric or general medical illness can benefit from interventions designed to enhance decisional capacity for research informed consent. In some cases, interventions have been rather lengthy or complex. The current study was designed to determine whether a brief intervention could improve decisional capacity in people with schizophrenia. Thirty individuals with schizophrenia and 30 healthy comparison participants were presented with a hypothetical research scenario. Decisional capacity was assessed with the MacArthur Competence Assessment Tool-Clinical Research version. Those with schizophrenia received a brief intervention aimed at improving understanding of the research protocol, after which decisional capacity was reassessed. A neuropsychological battery and symptom rating scales were also administered. At baseline, the schizophrenia group earned significantly lower scores than the comparison group on 2 aspects of decisional capacity (understanding, appreciation). At follow-up, the schizophrenia group had improved significantly on understanding and was no longer significantly different from the comparison group on any of the 4 dimensions of decisional capacity. Follow-up analyses also showed a significant effect of the intervention on a subset of the schizophrenia group who had performed most poorly at baseline. Participants with schizophrenia earned significantly lower scores than those in the comparison group across multiple neuropsychological domains. These findings add to the existing literature indicating that brief interventions can improve decisional capacity in individuals with schizophrenia, despite the fact that the illness typically causes significant cognitive dysfunction. The use of such interventions will enable a larger number of people with schizophrenia to make informed decisions regarding research participation.     

Decisional capacity of patients with schizophrenia to consent to research: taking stock

With the growth in recent years of studies of decisional capacity for research among people with schizophrenia, this is an opportune time to ask three questions: What have we learned from these studies? What remains to be learned? And what normative issues still need to be resolved? Among the things learned are that patients with schizophrenia, as a group, have lower scores on measures of decisional capacity than normals, but higher performance than patients with dementia. However, performance is highly variable within the group, correlates most strongly with neuropsychological impairment, and seems susceptible in many patients to successful remediation. The issues that remain in need of exploration include the development of a brief screening instrument for decisional capacity that can be used routinely, and the identification of those patients most likely to benefit from more intensive informational procedures. Finally, among the normative issues still in need of resolution are the degree of capacity needed to consent to research participation, how to deal with fluctuating capacity during research projects, and the legitimate extent of surrogate consent for participation of incompetent patients in research.     

Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: an overview

The capacity of individuals with schizophrenia to make decisions related to research participation or clinical treatment has received increasing empirical attention. A number of studies have compared patients with schizophrenia to nonpsychiatric comparison subjects (NPCs) on structured measures of decision-making capacity. In this review, we evaluated the magnitude of the difference between schizophrenia and NPC groups reported across these studies, as well as the influence of sample characteristics on observed effect sizes. We also computed the effect sizes of group differences in psychopathology and cognitive deficits. Twelve studies met the search criteria; a majority of them reported data using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) or for Treatment (MacCAT-T). The mean effect size (evaluated in terms of Cohen's d) for group differences on the Understanding subscale of the MacCAT instruments was 0.88 (SD = 0.40); it was twice as high among inpatient samples as among outpatients. Similar differences were observed in terms of Appreciation and Reasoning subscales, but the effect sizes for Expression of Choice were small (mean d = 0.29, SD = 0.24). Notably, these observed effect sizes were generally smaller than those for differences between schizophrenia and NPC groups in psychopathology (mean d = 2.06, SD = 1.03) and cognition (mean d = 1.01, SD = 0.61). The published studies demonstrate a substantial heterogeneity in decision-making capacity among people with schizophrenia, as well as among NPCs, suggesting that the presence of schizophrenia does not necessarily mean the patient has impairment in capacity.     

Correlates of treatment-related decision-making capacity among middle-aged and older patients with schizophrenia

BACKGROUND: Antipsychotic medications constitute the backbone of treatment for schizophrenia. Current guidelines require clinicians to obtain patients' informed consent for treatment, but few empirical studies of the capacity of patients with schizophrenia for meaningful consent in this context exist. This issue may be particularly relevant for middle-aged and older patients, as the cognitive changes associated with normal aging may have an adverse impact on decision-making processes. We examined the range, stability, and correlates of treatment-related decisional capacity in this patient population. METHODS: Participants included 59 middle-aged and older patients with schizophrenia or schizoaffective disorder and 38 normal comparison subjects. Baseline measures included the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), psychopathology rating scales, and the Mattis Dementia Rating Scale. Patients also completed a neuropsychological test battery. The MacCAT-T was readministered to patients at a 1-month follow-up. RESULTS: Relative to the comparison subjects, the patients had worse understanding of disclosed material; however, a wide range of performance was observed among patients. Variability in MacCAT-T performance was not predicted by demographic characteristics; there were no significant correlations between psychopathology ratings and MacCAT-T scores. Cognitive test scores were often significant correlates of capacity, particularly in terms of understanding and reasoning. The MacCAT-T scores were stable during the 1-month follow-up. CONCLUSIONS: Overall, middle-aged and older outpatients with schizophrenia had worse understanding of disclosed information than did normal comparison subjects, but such group comparisons obscure remarkable heterogeneity among patients. Differences in capacity appeared more related to cognitive functions than to severity of psychopathology. Such information about barriers to capacity may help in developing more effective methods of providing informed consent.     

Understanding of placebo controls among older people with schizophrenia

Research protocols frequently necessitate procedures or design elements that differ from those used in routine clinical care. An example is the inclusion of a placebo arm in many randomized clinical trials. Because there are risks to taking a placebo when one has a chronic disorder such as schizophrenia, ascertaining how well people with severe mental illness understand placebos is an important task for empirical research ethics. We investigated whether schizophrenia patients' understanding of placebo controls could be improved with a brief educational intervention. We randomized 49 middle-aged and older patients with schizophrenia or schizoaffective disorder to receive either (1) a routine explanation of placebos in the context of consent for a hypothetical double-blind placebo-controlled clinical trial, or (2) the consent for the hypothetical trial plus a brief educational module explaining placebos in more depth. Understanding of placebos was assessed with a 12-item questionnaire, and we examined demographic, clinical, neurocognitive, and decision-making correlates of understanding of placebos. Those participants who received the intervention obtained higher scores on the placebo post-test compared to those who received the standard information alone. Performance on the placebo post-test was positively correlated with measures of decisional capacity and neurocognitive abilities and negatively correlated with severity of negative symptoms, but it showed no relationship with positive or general symptoms. Some participants interpreted the common phrase "sugar pill" as relating somehow to diabetes. We conclude that the level of understanding of important research design-related information is not static but may be influenced by how investigators approach the consent process.     

The relationship of neuropsychological abilities to specific domains of functional capacity in older schizophrenia patients.

BACKGROUND: This study sought to determine the relative importance of cognitive measures in predicting various domains of everyday functional capacity in older outpatients with schizophrenia. METHODS: Ninety-three psychiatry outpatients with diagnoses of schizophrenia and schizoaffective disorders underwent a comprehensive neuropsychiatric evaluation, including neuropsychological testing and clinical ratings of psychopathology. Functional capacity was assessed with the Direct Assessment of Functional Status, a performance measure of basic and instrumental activities of daily living (ADLs/IADLs). RESULTS: Neuropsychological performance significantly predicted most ADLs/IADLs measured, except simple eating behaviors, time orientation, and grooming. Lower educational level and negative symptoms also were associated with worse functional capacity, whereas positive symptoms and depressed mood were not. Measures of cognitive functioning accounted for more variance in functional capacity than did psychiatric ratings of symptoms, and multiple regression analyses demonstrated that neuropsychological performance was predictive of functional capacity, over and above clinical symptoms. No specific cognitive domains were differentially predictive of specific domains of functional capacity. CONCLUSIONS: Neurocognitive abilities were more predictive of functional capacity than level of clinical symptoms; however, these abilities were not specific predictors of functioning. This is consistent with findings of relatively generalized, intercorrelated cognitive impairment in schizophrenia and multiply determined domains of everyday functioning.     

Relationship between financial competence and cognitive function in patients with schizophrenia

The present study examined financial competence in patients with schizophrenia and the relationship between their financial competence and cognitive function. The subjects consisted of 25 patients with schizophrenia (10 inpatients and 15 outpatients) and 22 normal controls who were community-dwelling people with no psychiatric disorders or cognitive deficit. To assess the subjects' cognitive function and financial competence, they completed the Japanese version of the Neurobehavioral Cognitive Status Examination (COGNISTAT), which has 10 subtests, and the Financial Competency Assessment Tool (FCAT), which has six subordinate domains of financial competence. Patients with schizophrenia performed significantly worse than the controls in all scores on the FCAT. The financial scores that were significantly different between the patients and the normal controls were significantly positively correlated with the scores on several COGNISTAT subtests (e.g. comprehension). These results suggest that patients with schizophrenia have problems with financial competence and that these problems may be accounted for by deficits in several cognitive functions.     

Multimedia consent for research in people with schizophrenia and normal subjects: a randomized controlled trial

Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols.     

Prevalence and correlates of adequate performance on a measure of abilities related to decisional capacity: differences among three standards for the MacCAT-CR in patients with schizophrenia

Despite the availability of structured decision-making capacity assessment tools, insufficient guidance exists for applying their results. Investigators often use cutpoints on these instruments to identify potential subjects in need of further assessment or education. Yet, information is lacking regarding the effects of different cutpoints on the proportion and characteristics of individuals categorized as possessing adequate or impaired decisional abilities for consent to research. To demonstrate the potential impact of different standards, we informed 91 individuals, aged 50 or older with a diagnosis of schizophrenia or schizoaffective disorder, about a hypothetical clinical trial, and assessed their decisional abilities with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Three published MacCAT-CR-based standards were applied to participants' scores to examine the rates and correlates of categorical determinations of adequate performance. The three standards ranged in stringency: the most stringent incorporated cutpoints on all three of the major MacCAT-CR subscales (Understanding, Appreciation, and Reasoning); the other two standards required threshold performance only on the Understanding subscale. The most stringent standard resulted in a 57% rate of impaired performance; the intermediate standard, 19%; and the least stringent standard, 8%. Nearly half of the participants (n=45) were classified as having performed adequately by the least stringent standard yet inadequately by the most stringent. The majority of these 45 were impaired on the Appreciation subscale (n=9), Reasoning (n=15), or both (n=18). Cognitive functioning was correlated with performance status for the more stringent standards. These findings underscore the need for refinement of capacity assessment procedures and for improvements in the use of capacity assessment tools for screening purposes and to assist in categorical capacity determinations.     

Cognitive predictors of medication adherence among middle-aged and older outpatients with schizophrenia

OBJECTIVE: Medication nonadherence presents a considerable problem in patients with schizophrenia. There are limited and conflicting data on the association of cognitive impairment with antipsychotic nonadherence. In this study, we evaluated the correlation of patients' scores on Mattis' Dementia Rating Scale (DRS; total and subscale scores) with scores on the Medication Management Ability Assessment (MMAA), a performance-based measure of medication management. METHODS: Participants included 110 outpatients with schizophrenia or schizoaffective disorder. Each was evaluated using the MMAA role-play tasks and the DRS. Patients also completed the Drug Attitude Inventory (DAI), and the PANSS (Positive And Negative Syndrome Scale). RESULTS: Age, DAI score, and DRS scores were all correlated with MMAA performance. In a stepwise regression analysis, only DRS scores were predictive of MMAA performance. Among the DRS subscales, conceptualization and memory were the best statistical predictors of MMAA performance. CONCLUSION: Cognitive functions, especially conceptualization and memory, were the strongest patient-related predictors of his or her ability to manage medications, over and above the effects of age, gender, education level, symptom severity, and attitudes toward medications. These results suggest a need for intervention studies focused on improving, or at least compensating for, specific cognitive deficits such as those in memory and conceptualization among patients with schizophrenia in order to improve their ability to manage medications.     

Insight, quality of life, and functional capacity in middle-aged and older adults with schizophrenia

OBJECTIVE: The quality of life (QOL) for individuals with schizophrenia is determined by a number of factors, not limited to symptomatology. The current study examined lack of insight as one such factor that may influence subjective QOL or functional capacity. It was hypothesized that insight would significantly interact with symptom severity to influence subjective QOL. Insight was not expected to influence the relation between symptom severity and functional capacity. METHODS: Participants were middle-aged and older outpatients who met diagnostic criteria for schizophrenia or schizoaffective disorder, and subsyndromal depression. Insight, psychopathology, and subjective QOL were assessed via semi-structured interviews and functional capacity was assessed via performance-based measures. RESULTS: Insight interacts with negative symptom severity to predict subjective QOL. Severity of negative symptoms and insight contribute directly to functional capacity. CONCLUSIONS: Individuals with intact insight may be better able to manage their symptoms, resulting in improved QOL. Treatment implications for improving the QOL of middle age and older adults with schizophrenia are discussed.     

An evaluation of longitudinal neurocognitive performance among middle-aged and older schizophrenia patients: use of mixed-model analyses

The purpose of this study was to evaluate the trajectory of neuropsychological performance among middle-aged and older patients with schizophrenia using hierarchical linear modeling (HLM). Using the Mattis Dementia Rating Scale (DRS), we assessed cognitive performance of 143 schizophrenia outpatients (Mean age=53.1 years, SD=8.8) and 66 healthy comparison subjects (Mean age=61.8 years, SD=8.8). All participants had DRS data from two or more testing sessions with average intervals between sessions being 15 months (range=6-55). Using HLM, we found cognitive performance to be stable over time in both schizophrenia patients and healthy comparison subjects. Age, gender, ethnicity, and education did not affect trajectories. We also analyzed the data using more traditional statistical approaches to longitudinal data and found similar results. In sum, we found cognitive impairment to be stable over time among outpatients with schizophrenia, regardless of the statistical methodology used to analyze longitudinal data.     

Neurocognitive and functional correlates of mobile phone use in middle-aged and older patients with schizophrenia

Objectives: Our objective was to examine the association of mobile phone use and ownership with psychopathology, cognitive functioning, and functional outcome in 196 outpatients aged 40 years and older who were diagnosed with schizophrenia.

Method: Participants reported their past and current mobile phone use on a standardized self-report scale and they were administered tests of global cognition, functional capacity, and informant-rated functional outcome.

Results: The great majority of subjects had used a mobile phone (78%) but few currently owned one (27%). After adjusting for age (mean age 51), any past mobile phone use was associated with less severe negative symptoms, and higher global cognitive performance, functional capacity, and functional outcome. A total of 60% of participants reported being comfortable with mobile phones, but comfort was not associated with any cognitive or functional outcomes.

Conclusion: Most of the older patients with schizophrenia have used mobile phones and lifetime mobile phone use is a positive indicator of cognitive and functional status.     

Assessment of physical activity in middle-aged and older adults with schizophrenia

BACKGROUND: Regular physical activity (PA) decreases morbidity in the general population; yet, information about the amount and effects of PA in persons with schizophrenia is scant. To develop interventions to increase PA and to assess its potential benefits in this group, accurate measurement of PA is needed. The purpose of this study was to characterize PA and determine the test-retest reliability and concurrent validity of the Yale Physical Activity Scale (YPAS), a self-report measure, in persons with schizophrenia. METHODS: PA was assessed with the YPAS, a scale of motivational readiness for PA, and accelerometry in middle-aged and older persons with a diagnosis of schizophrenia (n=54) and in a comparison group with no known psychiatric diagnosis (n=27). RESULTS: On the YPAS measures, persons with schizophrenia reported on average 11 h per week of PA, whereas the non-psychiatric comparison group reported about 32 h per week. Only about 30% of schizophrenia subjects were classified as being regularly active relative to 62% of the comparison group on PA motivational stages of readiness. On the accelerometry measures, the schizophrenia group had lower levels of light activity than the comparison group, but there were no differences in moderate and vigorous activity or sedentary behavior. Only in the comparison group were there significant associations between YPAS and accelerometer variables. Several YPAS scores demonstrated high test-retest reliability in both groups, and concurrent validity was supported between the YPAS and PA motivational stages of readiness. CONCLUSIONS: We found that the YPAS is a reliable measure of PA in schizophrenia for some indices. Although the YPAS demonstrated concurrent validity with other self-report measures, it did not demonstrate concurrent validity when compared to PA measured by accelerometry in persons with schizophrenia. Use of multiple measures, both subjective and objective, is recommended when assessing PA in schizophrenia.     

Short-term course of neuropsychological abilities in middle-aged and older adults with bipolar disorder

Objectives:  There are few longitudinal studies of neurocognition in bipolar disorder, and the short-term course of cognitive deficits in later-life bipolar disorder is unknown.
Methods:  We administered a battery of neurocognitive tests, repeated 1–3 years after baseline, to 35 community-dwelling outpatients with bipolar disorder (mean age = 58), and compared their performance on a composite measure of cognitive functioning to that of demographically matched samples of normal comparison subjects (NCs; n = 35) and patients with schizophrenia (n = 35). Using regression analyses, we examined group differences in baseline performance, trajectory of change over time, and variability in performance across time. Within the bipolar group, we examined the impact of baseline severity and change in severity of psychiatric symptoms on intra-individual change in neurocognitive performance.
Results:  At baseline, the group with bipolar disorder differed in overall neurocognitive functioning from the NCs, but did not differ significantly from the schizophrenia group. The bipolar group did not differ from the NCs or schizophrenia group in the mean trajectory of change between time-points, but the bipolar patients showed more intra-individual variability over time than the NCs or schizophrenia group. In the bipolar group, change in neurocognitive function was not related to baseline or change in psychiatric symptom severity.
Conclusions:  Middle-aged and older community-dwelling adults with bipolar disorder have greater short-term variability in level of neurocognitive functioning relative to NCs or people with schizophrenia. The developmental course of and risk factors for cognitive deficits in bipolar disorder should be examined in future longitudinal studies.     

A randomized, controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia

OBJECTIVE: The number of older patients with chronic schizophrenia is increasing. There is a need for empirically validated psychotherapy interventions for these patients. Cognitive behavioral social skills training teaches cognitive and behavioral coping techniques, social functioning skills, problem solving, and compensatory aids for neurocognitive impairments. The authors compared treatment as usual with the combination of treatment as usual plus cognitive behavioral social skills training. METHOD: The randomized, controlled trial included 76 middle-aged and older outpatients with chronic schizophrenia, who were assigned to either treatment as usual or combined treatment. Cognitive behavioral social skills training was administered over 24 weekly group sessions. Blind raters assessed social functioning, psychotic and depressive symptoms, cognitive insight, and skill mastery. RESULTS: After treatment, the patients receiving combined treatment performed social functioning activities significantly more frequently than the patients in treatment as usual, although general skill at social functioning activities did not differ significantly. Patients receiving cognitive behavioral social skills training achieved significantly greater cognitive insight, indicating more objectivity in reappraising psychotic symptoms, and demonstrated greater skill mastery. The overall group effect was not significant for symptoms, but the greater increase in cognitive insight with combined treatment was significantly correlated with greater reduction in positive symptoms. CONCLUSIONS: With cognitive behavioral social skills training, middle-aged and older outpatients with chronic schizophrenia learned coping skills, evaluated anomalous experiences with more objectivity (achieved greater cognitive insight), and improved social functioning. Additional research is needed to determine whether cognitive insight mediates psychotic symptom change in cognitive behavior therapy for psychosis.