Clinical trial NCT01433094: Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia
Official title: Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Non-Compliance
Schizophrenia and Related Disorders
Keywords: Adherence
Psychoeducation
Pharmacotherapy
Schizophrenia
Family support
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* diagnosis of psychosis in the spectrum of schizophrenia (ICD-10: F20 to F29); -age from 18 to 55;
* being in care for 2 years or more.

Exclusion Criteria:

* mental retardation, or any severe cognitive impairment;
* psychosis due to substance abuse or to a medical condition;
* affective psychosis;
* comorbid substance dependence;
* patient does not understand Italian language;
* pharmacotherapy with depot.

Primary outcomes:
measure: Adherence
timeFrame: Change from baseline in adherence to treatment at 6 months
Secondary outcomes:
measure: Psychotic symptoms
timeFrame: Changes from baseline in levels of psychotic symptoms at 6 months, with effects maintained at12 months and 18 months
measure: General level of psychopathology
timeFrame: Changes from baseline in levels of general psychopathology at 6 months, with effects maintained at 12 and 18 months
measure: Changes in the social functioning
timeFrame: Changes from baseline in social functioning at 6 months, maintained at 12 and 18 months
measure: Readmission
timeFrame: Occurrence of episodes of readmission over 27 months
Other outcomes:
Locations:
city: Urbino
country: Italy
facility: Università Degli Studi Di Urbino "Carlo Bo"
state: Urbino/Pesaro
city: Bari
country: Italy
facility: Università Degli Studi Di Bari
city: Brescia
country: Italy
facility: Fatebenefratelli Irccs
city: Cagliari
country: Italy
facility: Azienda Universitaria Ospedaliera Cagliari
city: Cagliari
country: Italy
facility: Università Degli Studi Di Cagliari
city: Campobasso
country: Italy
facility: Ausl 3 Centro Molise Di Campobasso
city: Catania
country: Italy
facility: Università Degli Studi Di Catania
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Martino Di Messina
Study officials:
affiliation: Department of Psychology, State University of Cagliari
name: donatella rita petretto, PhD eq
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falloon IR, Boyd JL, McGill CW, Williamson M, Razani J, Moss HB, Gilderman AM, Simpson GM. Family management in the prevention of morbidity of schizophrenia. Clinical outcome of a two-year longitudinal study. Arch Gen Psychiatry. 1985 Sep;42(9):887-96. doi: 10.1001/archpsyc.1985.01790320059008.
citation: Petretto DR, Preti A, Zuddas C, Veltro F, Rocchi MB, Sisti D, Martinelli V, Carta MG, Masala C; SPERA-S group. Study on psychoeducation enhancing results of adherence in patients with schizophrenia (SPERA-S): study protocol for a randomized controlled trial. Trials. 2013 Oct 7;14:323. doi: 10.1186/1745-6215-14-323.
citation: Petretto DR, Lussu C, Zuddas C, Pistis I, Piras P, Preti A, et al. Meta-Review of Systematic and Meta-Analytic Reviews on Family Psychoeducation for Schizophrenia. Austin J Clin Neurol 2017; 4(2): 1107.