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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
112
The intervention aims to improve communication and problem-solving abilities in patients and their families by sessions focused on: assessment of the individual's and the family's strengths, weaknesses, and goals; education about schizophrenia and treatment; communication skills training; problem-solving training; and special problems (Falloon et al. 1985). Treatment sessions are provided on a weekly basis for months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).
The comparator is a treatment with generic informative prospect on the disorders and with the same frequencies as the Intervention. Treatment sessions are provided on a weekly basis for 6 months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).
Università Degli Studi Di Urbino "Carlo Bo"
Urbino, Urbino/Pesaro, Italy
Università Degli Studi Di Bari
Bari, Italy
Fatebenefratelli Irccs
Brescia, Italy
Azienda Universitaria Ospedaliera Cagliari
Cagliari, Italy
Università Degli Studi Di Cagliari
Cagliari, Italy
Ausl 3 Centro Molise Di Campobasso
Campobasso, Italy
Università Degli Studi Di Catania
Catania, Italy
Azienda Ospedaliera Universitaria Policlinico Martino Di Messina
Messina, Italy
Adherence
Adherence will be checked with a triple method of assessment: patient's self-report, patient's replies to a four-query interview, and assessment of blood levels of the prescribed drug.
Time frame: Change from baseline in adherence to treatment at 6 months
Psychotic symptoms
The occurrence of psychotic symptoms, according to the Brief psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS)
Time frame: Changes from baseline in levels of psychotic symptoms at 6 months, with effects maintained at12 months and 18 months
General level of psychopathology
The general level of psychopathology will be measured according to the Health of the Nation rating scale (HoNOS)
Time frame: Changes from baseline in levels of general psychopathology at 6 months, with effects maintained at 12 and 18 months
Changes in the social functioning
Social functioning will be measured according to Personal and Social Performance scale (PSP). Quality of life will be measured as well, using the WHO-Quality of Life-Short version (WHOQOL-Bref).
Time frame: Changes from baseline in social functioning at 6 months, maintained at 12 and 18 months
Readmission
An episode of readmission is any admission to a psychiatric service for the necessity of controlling symptoms, behavior or therapy. Admission to the hospital for reason of somatic illness will be not considered an episode of readmission.
Time frame: Occurrence of episodes of readmission over 27 months
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