Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-01 @ 5:19 AM
Study NCT ID:
NCT07144592
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Solution-Focused Approach on Psychosocial Adjustment and Treatment Compliance in Individuals Diagnosed With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'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': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pretest (6-week solution-focused approach before the intervention)', 'timeFrame': 'Baseline (1 week before intervention)]', 'description': '1\\. Psychosocial Adjustment (PSSAS)\n\nDescription: Measured with the Psychosocial Adjustment Scale (PSSAS), which assesses social relationships, daily life management, and coping with stress. Scores range from 0 to 180; higher scores indicate better psychosocial adjustment.\n\nTime Frame: Baseline (within 1 week before intervention)\n\nUnit of Measure: Total score (0-180)'}, {'measure': 'pretest (6-week solution-focused approach before the intervention)', 'timeFrame': 'Baseline (within 1 week before intervention)', 'description': '2\\. Medication Adherence (MARS)\n\nDescription: Measured with the Medication Adherence Scale (MARS), which assesses adherence to prescribed pharmacological treatment. Scores range from 0 to 10; higher scores indicate better medication adherence.\n\nTime Frame: Baseline (within 1 week before intervention)\n\nUnit of Measure: Total score (0-10)'}], 'secondaryOutcomes': [{'measure': 'posttest (After the 6-week solution-focused approach intervention)', 'timeFrame': '6 weeks after baseline (post-intervention)', 'description': '1\\. Psychosocial Adjustment Post-Intervention (PSSAS)\n\nDescription: Psychosocial Adjustment Scale (PSSAS). Scores range from 0 to 180; higher scores indicate better psychosocial adjustment.\n\nTime Frame: 6 weeks after baseline (post-intervention)\n\nUnit of Measure: Total score (0-180)'}, {'measure': 'posttest (After the 6-week solution-focused approach intervention)', 'timeFrame': 'Post-intervention (6 weeks after completion of the intervention)', 'description': '2\\. Medication Adherence Post-Intervention (MARS)\n\nDescription: Medication Adherence Scale (MARS). Scores range from 0 to 10; higher scores indicate better medication adherence.\n\nTime Frame: Post-intervention (6 weeks after completion of the intervention)\n\nUnit of Measure: Total score (0-10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treatment adherence', 'Schizophrenia', 'solution-focused therapy,', 'psychiatric nursing'], 'conditions': ['SCHIZOPHRENIA 1 (Disorder)', 'Psychosocial Adaptation', 'Treatment Adherence']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of a solution-focused approach-based individual intervention on psychosocial adjustment and treatment adherence in individuals diagnosed with schizophrenia.\n\nThe study will be conducted as a randomized controlled trial including 60 clinically stable individuals diagnosed with schizophrenia according to DSM-5 criteria and registered at a Community Mental Health Center affiliated with a university hospital. Participants will be randomly assigned to an experimental group (n=30) and a control group (n=30).\n\nThe experimental group will receive one individual solution-focused therapy session per week for six weeks. The control group will receive usual care only. Data will be collected using a Personal Information Form, the Psychosocial Adjustment Scale (PSSAS), and the Medication Adherence Scale (MARS).', 'detailedDescription': 'Objective:\n\nSchizophrenia is a chronic psychiatric disorder that significantly affects thought, emotion, and behavior, often limiting social functioning, treatment adherence, and integration into daily life. There is an increasing need for person-centered, empowering, and brief intervention models in psychiatric nursing. This study aims to determine the effects of a solution-focused approach (SFA)-based individual intervention on psychosocial adjustment and treatment adherence in individuals with schizophrenia.\n\nStudy Design:\n\nThis research will use a pretest-posttest randomized controlled experimental design with a control group.\n\nStudy Population:\n\nThe study will include 60 individuals diagnosed with schizophrenia according to DSM-5 diagnostic criteria, considered clinically stable, and registered at a Community Mental Health Center affiliated with a university hospital in Türkiye. Participants will be randomly assigned to an experimental group (n=30) or a control group (n=30) using computer-assisted randomization.\n\nIntervention:\n\nExperimental Group: Participants will receive individual solution-focused therapy sessions once per week for six consecutive weeks. The sessions will emphasize individual strengths, recall positive coping experiences, support future goal setting, and provide guidance on repeating effective solutions.\n\nControl Group: Participants will receive no additional intervention beyond usual care.\n\nOutcome Measures:\n\nData will be collected with the following instruments:\n\nPersonal Information Form\n\nPsychosocial Adjustment Scale (PSSAS)\n\nMedication Adherence Scale (MARS)\n\nStatistical Analyses:\n\nPlanned analyses will include independent samples t-tests, paired t-tests, and ANCOVA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having been diagnosed with schizophrenia according to DSM-5 diagnostic criteria,\n\nBeing between 18 and 65 years of age,\n\nBeing literate and verbally communicative,\n\nBeing clinically stable (not exhibiting symptoms of acute psychosis),\n\nBeing registered with a Community Mental Health Center (CMHC) and receiving regular services,\n\nBeing cognitively competent enough to participate in individual interviews during the research process,\n\nBeing an individual currently receiving psychiatric treatment and taking medication,\n\nAgreeing to participate voluntarily in the study and signing a written informed consent form.\n\nExclusion Criteria:\n\n* those who do not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT07144592', 'briefTitle': 'The Effects of a Solution-Focused Approach on Psychosocial Adjustment and Treatment Compliance in Individuals Diagnosed With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Muş Alparslan University'}, 'officialTitle': 'The Effects of a Solution-Focused Approach on Psychosocial Adjustment and Treatment Compliance in Individuals Diagnosed With Schizophrenia', 'orgStudyIdInfo': {'id': '167678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group (Solution-Focused Approach Program)', 'description': 'A 6-week solution-focused approach program will be applied to the experimental group.', 'interventionNames': ['Behavioral: solution-oriented approach program']}, {'type': 'NO_INTERVENTION', 'label': 'control group (No Intervention: Usual Care at Community Mental Health Center)', 'description': 'No intervention will be applied to the control group'}], 'interventions': [{'name': 'solution-oriented approach program', 'type': 'BEHAVIORAL', 'description': "The solution-focused nursing intervention applied to the experimental group in the study was planned as individual sessions, consisting of one session per week, lasting a total of six weeks. The interventions were based on the principles of solution-focused brief therapy, focusing on the individual's strengths, past coping experiences, and current resources. The interviews aimed to identify exceptions, build positive future expectations, set small but achievable goals, strengthen hope, and increase the individual's ability to utilize their internal resources. Each session used structured open-ended questions, scaling techniques, and future-oriented solution scenarios to support the individual's psychosocial adjustment and motivation for treatment.", 'armGroupLabels': ['experimental group (Solution-Focused Approach Program)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Muş', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'muş alparsalan üniversity University', 'role': 'CONTACT', 'email': 'sbf@alparslan.edu.tr', 'phone': '0346 249 4949'}], 'facility': 'Community Mental Health Center', 'geoPoint': {'lat': 38.73163, 'lon': 41.48482}}], 'centralContacts': [{'name': 'Fatih Şahin, dr', 'role': 'CONTACT', 'email': 'fatih.sahin@alparslan.edu.tr', 'phone': '0534 688 1634'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'will be shared at the end of the research'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muş Alparslan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Fatih Sahin', 'investigatorAffiliation': 'Muş Alparslan University'}}}}