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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433094
First Posted: September 13, 2011
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
donatella rita petretto, University of Cagliari
  Purpose

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.


Condition Intervention
Patient Non-Compliance Schizophrenia and Related Disorders Behavioral: Falloon et al. Psychoeducation Program Behavioral: Generic Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia

Resource links provided by NLM:


Further study details as provided by donatella rita petretto, University of Cagliari:

Primary Outcome Measures:
  • Adherence [ Time Frame: 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:
  • Psychotic symptoms [ Time Frame: 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 [ Time Frame: 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)

  • Changes in the social functioning [ Time Frame: 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).

  • Readmission [ Time Frame: 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.


Enrollment: 112
Actual Study Start Date: September 2012
Study Completion Date: December 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433094


Locations
Italy
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
Sponsors and Collaborators
University of Cagliari
Investigators
Principal Investigator: donatella rita petretto, PhD eq Department of Psychology, State University of Cagliari
  More Information

Publications:
Responsible Party: donatella rita petretto, Assistant Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT01433094     History of Changes
Other Study ID Numbers: AIFA FARM892ZXE
First Submitted: August 20, 2011
First Posted: September 13, 2011
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by donatella rita petretto, University of Cagliari:
Adherence
Psychoeducation
Pharmacotherapy
Schizophrenia
Family support

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders