Schizophrenia and Related Disorders Clinical Trial
Official title:
Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia
Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders,
with a high impact on disability and participation. Poor adherence to pharmacotherapy
negatively impacts on the course and outcome of PSS.
Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of
relapse and readmission up to 5-time higher than in adherent patients. Falloon et al.
developed a Psychoeducation Program (FPP) aimed at improving communication and
problem-solving abilities in patients and their families. Past studies reported a
statistically significant reduction of the risk of relapse in patients receiving the FPP, but
did not take into account effects on adherence.
Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients
diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with another
group exposed to a treatment with generic informative prospects on the disorders provided
with same attendance frequency as the FPP (Generic Treatment - GT).
Methods: 340 patients with PSS, from 10 participating units distributed in the territory of
the Italian National Health System, will be enrolled, with allocation 1:1. The sample will be
randomized into an exposed group (to FPP) and an unexposed group. Adherence will be assessed
on a three-monthly basis with blood levels of the primary prescribed drug by High Pressure
Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire, and
concurrently with the administration of a 4-item interview, based on a modified version of
the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method,
followed by Log-rank test, defining as terminal events both the start of non-adherence and/or
the first relapse or readmission episode. Intention-to-treat will be applied in considering
the primary and secondary outcomes. Multiple imputations will be applied to integrate missing
data.
Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already
in contact with a psychiatric service is 47%; effect size of psychosocial treatment on
various outcomes, including relapse, readmission and adherence to drug is 0.48 of the
standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce
a change in the prevalence of non-adherence to drug in the exposed group with an effect size
of 0.45 SD.
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