Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT01433094
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2011-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-06', 'studyFirstSubmitDate': '2011-08-20', 'studyFirstSubmitQcDate': '2011-09-10', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence', 'timeFrame': 'Change from baseline in adherence to treatment at 6 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Psychotic symptoms', 'timeFrame': 'Changes from baseline in levels of psychotic symptoms at 6 months, with effects maintained at12 months and 18 months', 'description': 'The occurrence of psychotic symptoms, according to the Brief psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS)'}, {'measure': 'General level of psychopathology', 'timeFrame': 'Changes from baseline in levels of general psychopathology at 6 months, with effects maintained at 12 and 18 months', 'description': 'The general level of psychopathology will be measured according to the Health of the Nation rating scale (HoNOS)'}, {'measure': 'Changes in the social functioning', 'timeFrame': 'Changes from baseline in social functioning at 6 months, maintained at 12 and 18 months', 'description': '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).'}, {'measure': 'Readmission', 'timeFrame': 'Occurrence of episodes of readmission over 27 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adherence', 'Psychoeducation', 'Pharmacotherapy', 'Schizophrenia', 'Family support'], 'conditions': ['Patient Non-Compliance', 'Schizophrenia and Related Disorders']}, 'referencesModule': {'references': [{'pmid': '2864032', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24099414', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nNon-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.\n\nObjectives: 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).\n\nMethods: 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.\n\nExpected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of psychosis in the spectrum of schizophrenia (ICD-10: F20 to F29); -age from 18 to 55;\n* being in care for 2 years or more.\n\nExclusion Criteria:\n\n* mental retardation, or any severe cognitive impairment;\n* psychosis due to substance abuse or to a medical condition;\n* affective psychosis;\n* comorbid substance dependence;\n* patient does not understand Italian language;\n* pharmacotherapy with depot.'}, 'identificationModule': {'nctId': 'NCT01433094', 'acronym': 'SPERA-S', 'briefTitle': 'Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia', 'orgStudyIdInfo': {'id': 'AIFA FARM892ZXE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Falloon et al. Psychoeducation Program', 'description': "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", 'interventionNames': ['Behavioral: Falloon et al. Psychoeducation Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Generic Treatment', 'description': '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).', 'interventionNames': ['Behavioral: Generic Treatment']}], 'interventions': [{'name': 'Falloon et al. Psychoeducation Program', 'type': 'BEHAVIORAL', 'otherNames': ['Family psychoeducation'], 'description': "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).", 'armGroupLabels': ['Falloon et al. Psychoeducation Program']}, {'name': 'Generic Treatment', 'type': 'BEHAVIORAL', 'description': '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).', 'armGroupLabels': ['Generic Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Urbino', 'state': 'Urbino/Pesaro', 'country': 'Italy', 'facility': 'Università Degli Studi Di Urbino "Carlo Bo"', 'geoPoint': {'lat': 43.72621, 'lon': 12.63633}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Università Degli Studi Di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Fatebenefratelli Irccs', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cagliari', 'country': 'Italy', 'facility': 'Azienda Universitaria Ospedaliera Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Cagliari', 'country': 'Italy', 'facility': 'Università Degli Studi Di Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Campobasso', 'country': 'Italy', 'facility': 'Ausl 3 Centro Molise Di Campobasso', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Università Degli Studi Di Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Policlinico Martino Di Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'overallOfficials': [{'name': 'donatella rita petretto, PhD eq', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychology, State University of Cagliari'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'donatella rita petretto', 'investigatorAffiliation': 'University of Cagliari'}}}}