Study Design
This study was approved by the human subjects committees of
the University of California, San Diego, and the Department of
Veterans Affairs San Diego Healthcare System. Because transportation
problems are common among older patients with schizophrenia,
cognitive behavioral social skills training was delivered
both at the research center (N=52) and at different board-and-care
facilities in the community (N=24). Transportation to group therapy
and to all assessment appointments at the research center was
provided if requested. After the patients provided written informed
consent and underwent baseline assessments, they were
randomly assigned to one of two treatment conditions: 1) treatment
as usual or 2) treatment as usual plus cognitive behavioral
522 Am J Psychiatry 162:3, March 2005
OLDER PATIENTS WITH SCHIZOPHRENIA
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social skills training. They were followed up at midtreatment (3
months), to determine process and symptom outcomes, and at
the end of treatment (6 months), to assess functioning, symptom,
and process outcomes. A stratified randomization procedure was
used to assign participants to treatments within sites, with the
constraint that equal numbers of patients at each site would be assigned
to the two conditions according to a sequential list of random
numbers. The project coordinator assigned participants to
treatments in the order that they consented, and the coordinator
was the only staff person other than therapists with knowledge of
group membership. The participants were compensated for the
assessment visits but not for the treatment visits.