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NCT Number: NCT01433094

Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia

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.

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Key information

Conditions

Patient Non-compliance Behavior Health Behavior Mental Disorders Patient Acceptance of Health Care Patient Compliance Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia and Related Disorders Treatment Adherence and Compliance

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Degli Studi Di Urbino "Carlo Bo", Urbino, Urbino/Pesaro, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Falloon et al. Psychoeducation Program

Behavioral

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

Generic Treatment

Behavioral

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 outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Acronym: SPERA-S

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2011
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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