Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia

Not Applicable

Completed

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

• Registration Number: NCT01433094
• Lead Sponsor: University of Cagliari

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-20
• Study First Submitted QC: 2011-09-10
• Study First Posted: 2011-09-13
• Study Start: 2012-09
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-06
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Falloon et al. Psychoeducation Program	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
Generic Treatment	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).

Primary Outcome Measures

Name	Time	Method
Adherence	Change from baseline in adherence to treatment at 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Readmission	Occurrence of episodes of readmission over 27 months	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.
Changes in the social functioning	Changes from baseline in social functioning at 6 months, maintained at 12 and 18 months	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).
Psychotic symptoms	Changes from baseline in levels of psychotic symptoms at 6 months, with effects maintained at12 months and 18 months	The occurrence of psychotic symptoms, according to the Brief psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS)
General level of psychopathology	Changes from baseline in levels of general psychopathology at 6 months, with effects maintained at 12 and 18 months	The general level of psychopathology will be measured according to the Health of the Nation rating scale (HoNOS)

Trial Locations

Locations (8)

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

Ausl 3 Centro Molise Di Campobasso; 🇮🇹 Campobasso, Italy

Università Degli Studi Di Cagliari; 🇮🇹 Cagliari, Italy

Università Degli Studi Di Catania; 🇮🇹 Catania, Italy

Azienda Ospedaliera Universitaria Policlinico Martino Di Messina; 🇮🇹 Messina, Italy