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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Falloon et al. Psychoeducation Program | Experimental | 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 | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| donatella rita petretto, PhD eq | Department of Psychology, State University of Cagliari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Degli Studi Di Urbino "Carlo Bo" | Urbino | Urbino/Pesaro | Italy | |||
| Università Degli Studi Di Bari |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2864032 | Background | 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. | |
| 24099414 | Background |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
|
| 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). |
|
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 |
| 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 |
| 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. |
| Background | 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. |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |