Participants were outpatients recruited for an NIMH-funded trial examining the efficacy of environmental supports for improving outcomes in schizophrenia. Of 120 randomized, 113 had a baseline and at least one follow-up assessment and comprised the intent to treat sample for data analysis. See for a description of patient flow.
Subjects were identified through chart reviews by research staff credentialed at participating sites. In accordance with HIPAA requirements, a waiver was obtained through the university’s institutional review board to allow research staff privileged at participating clinics to review basic diagnostic and demographic data and identify eligible individuals for study participation. After obtaining consent of the treating physician, research staff approached eligible individuals for participation. The researcher explained the study to prospective participants and answered any questions relating to participation. All participants signed a written consent form approved by the University’s Institutional Review Board.
Subjects met the following inclusion criteria: Diagnosis of schizophrenia/schizoaffective disorder according to the Structured Clinical Interview for DSM-IV, between 18 and 60 years of age, receiving treatment with an atypical antipsychotic medication other than clozapine, no hospitalizations within the past 3 months, having a stable living environment for the past 3 months. Subjects were excluded if substance abuse interfered with their study participation (e.g. assessment or treatment), if they had a documented history of significant head trauma, seizure disorder, neurological disorder or mental retardation, if they were currently being seen by an Assertive Community Treatment Team, if they had a history of violence in the past one year period, or if they had a score on the Social and Occupational Functioning Scale greater than 80 indicating a high level of adaptive functioning.
57 subjects were male and 56 were female. 45 were Hispanic, 44 were Non-Hispanic White, 24 were African-American, or from other or mixed ethnic groups. Mean age of participants was 41.0 (S.D. = 9.1).
Following a baseline assessment, subjects in standard medication and case management were randomly assigned to one of three treatments 1) CAT, 2) GES or 3) treatment as usual (TAU). The treatment period lasted for 24 months. In CAT, after an initial 9 months of weekly home visits, visits were decreased in frequency from weekly to monthly from months 9–12 and participants were seen monthly through 24 months. Assessments were conducted at baseline and 3, 6, 9, 18 and 24 months follow-up.
2.3 Treatment Groups
Cognitive Adaptation Training is a manual-driven series of compensatory strategies based upon neuropsychological, behavioral, and occupational therapy principals (Velligan et al., 2000
). Prior to participating in CAT, all patients receive comprehensive behavioral, neuropsychological, functional, and environmental assessments. These assessment procedures described in detail elsewhere, form the basis for the treatment plan (Velligan et al., 2006
; Maples & Velligan, in press
CAT treatment plans are customized for each person’s level of apathy versus disinhibition and each individual’s level of impairment in executive functions (the ability to plan and carry out goal-directed activities (Velligan et al., 2006
). Behaviors characterized by apathy can be altered by providing prompting and cueing to initiate each step in a sequenced task. For example, CAT therapists may provide checklists for tasks which involve complex behavioral sequencing or place signs and equipment for daily activities directly in front of the patient (e.g., a checklist for cleaning the kitchen). Individuals who exhibit disinhibited behaviors respond well to the removal of distracting stimuli and behavioral triggers and to redirection. For example, a CAT therapist may help to discourage wearing clothing that is inappropriate for the weather by working with the individual to place such items in a container under the bed. Individuals with mixed behavior (apathy and disinhibition) are offered a combination of these strategies.
Individuals with greater degrees of executive impairment are provided a greater level of structure and assistance and more obvious environmental cues (larger, brighter, more proximally placed). Individuals with less impairment in executive function can perform instrumental skills adequately with less structure, and more subtle cues. These general plans are adapted for individual strengths or limitations in other cognitive areas. Interventions are explained, maintained and altered as necessary by brief (30 minute) weekly visits from a CAT trainer. After 9 months, treatment was decreased during months 9–12 from every week, to every other week and then to monthly. All patients were seen monthly from month 12–24.
General Environmental Supports (GES) is a manual-driven series of environmental supports offered to patients at their regular clinic visit. The GES package was designed using the supports that were most frequently used and described as most helpful by clients in the CAT program. In addition, supports selected for the GES package were those that required minimal training to use. Supports for GES included, an alarm clock, a watch, bus passes (in marked envelopes for specific destinations), a checklist of everyday activities (e.g. taking medication, showering), hygiene products (e.g. shampoo, toothpaste), pill containers, reminder signs (e.g. "Did I take my medication?", and a bookstore gift card (for leisure activities (Velligan et al., 2006
In the present study, GES therapists offered the same supports to all subjects and provided instructions on how to use each item. The GES therapist discussed with the client where to place signs to get maximum benefit, and how to set use watches, alarms, bus passes and pill containers. The session was audio taped and the client was given both the tape and the tape-recorder to replay the instructions any time. Once monthly, the therapist called the client and asked if the client needed any replacement supplies. If supplies were needed, the client picked them up from the clinic. For some patients, for the purposes of the study, supports were dropped off at the client’s home.
Symptom and functional assessments were administered by Bachelor’s, (n=4) and Master’s level (n=5) psychologists required to reach a criterion of .80 intraclass correlation coefficient on a combination of video recorded and live interviews for each assessment prior to making ratings. In addition, all raters were observed in assessment interviews at regular intervals throughout the trial to ensure standardized and competent administration of all scales. Regular meetings were held to prevent rater/scorer drift as recommended by Ventura et al., (1993)
Adaptive Functioning—The primary outcome variable for the study was the Social and Occupational Functioning Scale (SOFAS) (DSM-IV; APA, 1998). This instrument assesses the overall level of function on a scale from 1 to 100 based upon social, school and work functioning. Higher scores indicate better adaptive function. The SOFAS score was based upon all information obtained during several hours of assessments conducted by blinded raters.
As a secondary measure of adaptive functioning we utilized scores on the Multnomah Community Ability Scale (MCAS). The MCAS is a 17-item scale assessing a variety of domains of community adjustment following a lengthy interview with the participant. Higher scores reflect better community functioning.
Positive symptomatology was assessed using the Psychosis Factor from the Brief Psychiatric Rating Scale-Expanded version (BPRS) which rates psychosis symptoms on a 7-point scale ranging from 1 (absent) to 7 extremely severe. Motivation (a subscale of the Negative Symptom Assessment; Alphs et al., 1989
) was utilized to examine the effect of treatment on motivational difficulties and participation in activities. Previous studies demonstrated improvements on the motivation difficulties subscale with CAT in comparison to an active control and treatment as usual (Velligan et al. 2006
). The motivation subscale is composed of items assessing grooming, interests, engagement in activities, and sense of purpose. Lower scores indicate fewer motivational problems.
2.5 Treatment Blinds
In an effort to maintain treatment blinds, all subjects and collaterals were asked at the beginning of each assessment neither to divulge information about any visits made by staff of the research project nor to refer to any items they may have received as part of the study. If blinds were broken, alternative raters blind to group assignment completed the remaining assessments
2.6 Data Analysis
We examined distributions for normality and homogeneity of variance and used transformations where necessary to meet the assumptions of the statistical models. The primary outcome variable was the score from the social and occupational functioning scale. Secondary variables were a more detailed measure of functional outcome (MCAS) and measures of positive and negative symptoms. We examined group differences in functional outcomes (SOFAS score and MCAS) and symptomatology (BPRS positive symptom score NSA motivation over time (3, 6, 9, 18, 24 months) by treatment group (CAT, PharmCAT, Treatment as Usual) using mixed effects regression with repeated measures (SAS PROC MIXED; Cary Institute 1990). A random subject effect was included modeling intercept, linear and quadratic trend components. Baseline scores were used as covariates in the model. Group differences were tested by estimating group means at each of the assessment points from the model using an overall F test and pair-wise t tests at points of interest. Graphs of outcome variables depict lines generated from random regression model estimates and include the common baseline (covariate).
A priori power calculations were based upon the results obtained from pilot data for both functional and positive symptom measures (Velligan et al., 2002). In the pilot study, large effect sizes (greater than or equal to .8) were found between CAT and TAU for both types of measures. Therefore, in the current study, we estimated the power of detecting similar large effect size differences as significant using a two-sided alpha of .01 with a final sample size of 40 per group to be between .80 and .96 (Lipsey, 1990
To investigate whether statistically significant effects were clinically meaningful, effect sizes were calculated for the primary outcome utilizing the standard deviation for the outcome variable in the control group pooled over time. This standard deviation represents an estimate of the population standard deviation in a treatment as usual condition.