Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia (SPERA-S)

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 Overview

• Status: Completed
• Conditions: Schizophrenia and Related Disorders; Patient Non-Compliance
• Intervention / Treatment: Behavioral: Falloon et al. Psychoeducation Program; Behavioral: Generic Treatment

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy
    • Università degli Studi di Bari
  • Brescia, Italy
    • Fatebenefratelli Irccs
  • Cagliari, Italy
    • Azienda Universitaria Ospedaliera Cagliari
  • Cagliari, Italy
    • Università degli Studi di Cagliari
  • Campobasso, Italy
    • Ausl 3 Centro Molise Di Campobasso
  • Catania, Italy
    • Universita degli Studi di Catania
  • Messina, Italy
    • Azienda Ospedaliera Universitaria Policlinico Martino Di Messina
  • Urbino/Pesaro
    • Urbino, Urbino/Pesaro, Italy
      • Università Degli Studi Di Urbino "Carlo Bo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Falloon et al. Psychoeducation Program; 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	Behavioral: Falloon et al. Psychoeducation Program; 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).; Other Names: Family psychoeducation
ACTIVE_COMPARATOR: Generic Treatment; 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).	Behavioral: Generic Treatment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline in adherence to treatment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychotic symptoms	The occurrence of psychotic symptoms, according to the Brief psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS)	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)	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).	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.	Occurrence of episodes of readmission over 27 months

Collaborators and Investigators

• Sponsor: University of Cagliari
• Investigators: Principal Investigator: donatella rita petretto, PhD eq, Department of Psychology, State University of Cagliari

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2012
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: August 20, 2011
• First Submitted That Met QC Criteria: September 10, 2011
• First Posted (ESTIMATE): September 13, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Adherence; Schizophrenia; Psychoeducation; Pharmacotherapy; Family support
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: AIFA FARM892ZXE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No