Schizophrenia Clinical Trial
Official title:
Cognitive Behavioral Social Skills Training in Early-onset Psychosis: Efficacy in Psychotic Symptoms, Psyshosocial Functioning and Neurobiological and Epigenetic Stress Markers.
Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended
psychological interventions to improve symptomatology and functional recovery in psychosis.
In addition, CBT may reduce hyperactivation of the brain structures responsible for the
stress response. In patients with early onset psychotic disorder (EOP) there are not any
previous controlled study that has analyzed the efficacy of this type of intervention.
The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional
improvement after the treatment in patients with EOP. The study will also examine the
potential effect of the intervention on neurobiological stress markers.
Early-onset of psychotic disorders (EOP), and especially Schizophrenia, is associated with a
worse clinical and psychosocial evolution than in the adult form of the illness. In the case
of patients with EOP, international and national clinical guidelines recommend the
combination of pharmacological treatment with CBT. However there are not any previous
controlled study that has analyzed the efficacy of this type of psychological intervention.
A controlled randomized study will be carry out of CBT + SST intervention compared to a
control intervention of the same duration, format and contact with a therapist. The sample
will be 30 participants with a diagnosis of schizophrenia, Schizoaffective disorder or
psychotic disorder not otherwise specified diagnosed between 9 and 18 years. Patiens have to
be in the early phase of the disease (first 5 years after the onset) and in non-acute
treatment. All participants will be evaluated before and after the intervention with clinical
scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age,
puberal stage and sex will be also recruited and evaluated only at baseline point. The
evaluations will be carried out by blind evaluators. Intention-to-treat analysis will be
carry out using the statistical package SPSS v 20.
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