Schizophrenia Clinical Trial
Official title:
Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia
Cognitive Remediation (CR) involving restorative and strategy-based methods has been
previously validated in a pilot study for late life schizophrenia (LLS), where CR
demonstrated a moderate effect on overall cognition. This study proposes to study the
efficacy of CR in a larger cohort of participants with LLS and to assess the interaction of
medication management with CR on cognitive outcomes. Eligible participants will receive CR
during 12 weeks. CR consists of a series of computerized exercises targeting various
cognitive functions, such as memory, attention and processing speed. It will be administered
during facilitated group sessions consisting of 4-6 people.
The study will recruit 40 participants with the aim to enroll 30 LLS participants age 55 or
older who will undergo the CR intervention for two, 2-hour weekly classes over 12 weeks (24
classes in total). There will be baseline assessments (clinical and NP) prior to enrollment
in the classes. In order to assess whether there has been a change in cognition, and some of
the assessments will be repeated after the 12-week intervention.
Thirty late life schizophrenia (LLS) participants, age 55 and over, will undergo the CR
intervention after completion of the baseline assessments. CR is a group-based psychotherapy
that will consist of two, 2-hour weekly therapist-guided classes over 12 weeks, with a
half-hour lunch break. The 24 classes are divided into two iterations of 12 exercises each,
repeated twice. CR consists of four techniques: (1) didactic teaching on the relevance of
cognition for everyday functioning and the association between cognitive strategies and
enhanced functioning (2) computerized drills targeting different cognitive domains, (3)
in-class strategic monitoring to enhance metacognitive skills, and (4) discussion of the
generalization of cognitive skills to daily life. The Brain Gym includes electronic tablets
for participant use both during classroom sessions in addition to elective, drop-in practice
sessions offered three times per week. Each group will consist of 4-6 participants. A group
will be started once four to six consecutively referred participants complete baseline
assessments. Each class is self-contained and the first class is always introductory to CR in
order to enhance the comfort level with the computer equipment and program.
Each of the 24 classes will have one, 5-10 minute block of didactic teaching, two 45-minute
blocks of drill-and-practice of the online exercises, and a 20-minute lunch break. Exercises
are delivered via Scientific Brain Training (SBT) Pro (2009). Computer exercises are designed
to be enjoyable and reinforcing, with the difficulty level gradually increasing over time.
The therapists optimize competency and motivation by individualizing the exercises for each
participant. The difficulty level parameters are manually titrated according to exercise
adherence and difficulty level progression, targeting 80 percent accuracy in order to
optimize competency and motivation. In order to optimize learning and retention outside of
weekly classes, participants are encouraged to return to the computer lab for ongoing
practice of the online exercises, targeting 40 minutes of homework exercises per weekday for
a total target of 200 minutes per week. Online logs allow for monitoring the time spent
completing the computer exercises. The therapists review the online logs on a weekly basis
with the participants at the end of the didactic class and before planning the homework for
the following week. Participants' successful completion of a given exercise to the highest
difficulty level is charted in the Brain Gym using their anonymized computer log-in name to
serve as positive reinforcement and recognition of their achievement while maintaining
privacy.
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