Clinical Trial Summary
Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses
that incur substantial suffering for patients and major challenges to the investigators
health care and legal systems. The prodrome is the period prior to onset of psychosis when
functional decline and clinical symptoms gradually emerge. The presence of a clinical
high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the
later development of psychosis, and for those who do not necessarily go on to develop a
psychotic illness, research has suggested that the majority continue to have fluctuating
subthreshold symptoms and poor social and role functioning. There are no specific treatments
to help with these functional difficulties. However, recent findings suggest that in people
with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to
significantly greater increase in the frequency of social functioning activities compared to
treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is
a feasible treatment for CHR. This proposal is a competitive application for a three-site,
longitudinal study aimed at testing the effectiveness and feasibility as well as mediators
and mechanisms of action of a manualized CBSST intervention that will target functional
difficulties associated with clinical risk states for psychosis. The goals are 1) to examine
whether CBSST compared to a placebo intervention (psychoeducation) matched for group
involvement and therapist time improves functioning in youth at CHR and 2) to determine
whether reduction in defeatist beliefs and improvement in social competence mediate change in
psychosocial functioning in CHR youth in the CBSST. In this single-blind randomized 2-arm
trial participants will be randomized to one of two treatments: CBSST, an 18-week group
comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or
a psychoeducation support group that does not teach active cognitive behavioral therapy or
social skills training. Over a five-year period, the multi-site collaboration will follow
large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral
changes, to examine changes in social and role functioning, as well as symptom changes from
baseline to the end of treatment, and to 6 month follow-up. This approach will demonstrate
the feasibility of a treatment for which it is easy to train therapists and which can readily
be disseminated to regular clinical community practice. In addition, it will provide insights
into likely approaches to halting or mitigating the pathological process and advance the
investigators understanding of risk prediction; both critical steps in prevention.
