Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT04280835
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2020-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychoeducation in Patients Who Diagnosed With 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The research was using quasi-experimental research methods. The experimental group was composed of patients with schizophrenia registered at Community Mental Health Center and the control group was composed of outpatients diagnosed with schizophrenia who applied to Psychiatric Polyclinic.The patients met the inclusion criteria of the study and volunteered to participate in the study.The study was completed with 42 patients (n=21for the intervention group; n=21 patients for the control group).Psychoeducation program were applied to intervention group. No intervention was performed on the patients in the control group.To the experimental and control group, at screening (pre-test), eight weeks after screening (post-intervention/post-test), three months after the post tests (follow-up) was applied.The mesurements were taken simultaneously in the intervention and control groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Scale for Schizophrenia (QLSS)', 'timeFrame': 'Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)', 'description': 'It evaluates the quality of life of schizophrenic patients receiving maintenance treatment. QLSS provides information about ongoing symptoms and functionality. It is a 7-degree Likert type scale applied in a semi-structured interview format. It consists of a total of four sub-dimensions and 21 questions in the form of interpersonal relationships, professional role, psychic findings and daily item use-activities. The total score of all subscales gives the total score (0-126) of quality of life.'}, {'measure': 'Medication Adherence Rating Scale (MARS)', 'timeFrame': 'Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)', 'description': "The scale assesses the patient's compliance behaviors and attitude to treatment. The scale consists of 10 questions to answer in the form of Yes/No (between 1-7 were poor in compliance with treatment and those with scores between 8-10 were high)."}, {'measure': 'Flourishing Scale (FS)', 'timeFrame': 'Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)', 'description': "It is a self-assessment scale measures an individual's level of well-being. It consists of eight items and each item is scored 1-7 points. The total score range from 8-56 points. The more the score from the scale increases the more the well-being increases."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'psychoeducation', 'compliance to treatment', 'quality of life', 'well-being'], 'conditions': ['Quality of Life', 'Well-Being', 'Compliance, Treatment']}, 'descriptionModule': {'briefSummary': 'People with schizophrenia are faced with social problems such as repeated hospitalizations, stigma with lack of social skills, unemployment, lack of necessary and adequate health care and education due to lack of adequate care in the community they live in. It is known that psychoeducation practices aimed at developing social skills in schizophrenia give patients new skills and these skills continue for many years. This study aimed to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.', 'detailedDescription': 'The aim is to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.\n\nThe study was conducted with 42 schizophrenia patients (n=21 intervention group; n=21 control group) using a quasi-experimental research design. Patients were evaluated using a pre-test, post-test, monitoring test, "Medication Adherence Rating Scale (MARS)", "Quality of Life Scale for Schizophrenia (QLSS)" and "Flourishing Scale" (FS). The measurements were taken 3 times: pre test, post-test and 3-months post-test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering\n* Being 18 and over being literate\n* Having been diagnosed with schizophrenia for at least three months\n* Taking oral antipsychotics\n* Being in remission.\n\nExclusion Criteria:\n\n* Being in an acute period of exacerbation\n* Actively using alcohol or psychoactive substances\n* Having mental retardation or dementia\n* Having another psychiatric illness that makes it impossible to cooperate.'}, 'identificationModule': {'nctId': 'NCT04280835', 'briefTitle': 'Psychoeducation in Patients Who Diagnosed With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Effect of Group Psychoeducation That Focused on Social Skills Development Applied to Patients Who Diagnosed With Schizophrenia on Treatment Compliance, Quality of Life and Well-being', 'orgStudyIdInfo': {'id': 'MKTatu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Psychoeducation that Focused on Social Skill Development', 'description': 'The Psychoeducation program that focused on social skill development, consists of 8 sessions, one day a week, each lasting an average of 60 Minutes. Psychoeducation was conducted in three groups and each of them consisted of eight patients.', 'interventionNames': ['Behavioral: Group Psychoeducation that Focused on Social Skill Development']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "No intervention was performed on the patients in the control group, and routine follow-up (arranging treatment by the doctor, answering the patient's and family's questions about treatment) continued in the polyclinic."}], 'interventions': [{'name': 'Group Psychoeducation that Focused on Social Skill Development', 'type': 'BEHAVIORAL', 'description': 'Psychoeducation Program consists of; Preparatory Session, Recognition of Schizophrenia, Evaluating the Treatment of Schizophrenia, Stress and Coping with Stress, Improving Communication Skills, Improving Problem-solving Skills, Improving Interpersonal relationships and social activities and Evaluating Session.The sessions were held in the form of PowerPoint presentations. In the psychoeducation program, lecture, question-answer, homework, sharing experiences, group discussion, repetition, video presentation, summarization, reinforcer, and role-playing techniques were used. The day before each session, patients were phoned and reminded of the time of the session. At the end of each session, the content of the subject is given as hard copy and cookies, tea and coffee were served.', 'armGroupLabels': ['Group Psychoeducation that Focused on Social Skill Development']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06500', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Merve Kızılırmak Tatu', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Merve Kızılırmak Tatu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University Health Science Faculty, Ankara, Turkey.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Other researchers will be able to read detailed information such as the research method and results when the research is published. The "Research Protocol" will be available on the this PRS page.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Merve Kızılırmak Tatu', 'investigatorAffiliation': 'Gazi University'}}}}