]>
IRCT20251128068139N1 IRCT 2025-12-14 Alborz University of Medical Sciences The Impact of Group Cognitive Behavioral Therapy on the Mental Health, Stigma, and Social Capital of Patients with Severe Psychiatric Disorders and Its Effect on Their Caregivers The Impact of Group Cognitive Behavioral Therapy on the Mental Health, Stigma, and Social Capital of Patients with Severe Psychiatric Disorders (Bipolar Disorder, Schizophrenia, and Schizoaffective Disorder) and Its Effect on Their Caregivers 2025-12-22 anticipated 60 Complete https://irct.ir/trial/87929 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study will be straightforward and will rely on the available samples through simple randomization. Once eligible patients have been identified, statistical randomization software will be utilized to assign them to either the intervention or control groups. This randomization will be conducted on an individual basis. Patients will be divided into the two groups based on relevant psychiatric diagnoses and demographic criteria. To ensure impartiality, the researchers conducting the study (who will be implementing group training using cognitive behavioral therapy), the outcome assessor, and the researcher analyzing the data will be kept unaware of the assignment of patients to the intervention and control groups. The allocation will be managed by two participants who are not involved in the research design, Blinding description: The researchers conducting this study, who will implement group training using cognitive behavioral therapy and the outcome assessors who will collect the data, as well as the researcher who will analyze it, will be unaware of how patients are allocated to either the intervention or control groups. Patient allocation will be managed by two participants who are not involved in the study's design. Therefore, the study will be conducted in a triple-blind manner. The authors drafting the manuscript will also remain unaware of the patient allocations, including their identities and referral sites. All patients and caregivers considered for participation in the study will be fully informed about the study before it begins, and written informed consent will be obtained from them prior to the start of the research. N/A Condition 1: Severe Psychiatric Disorders. Condition 2: Severe Psychiatric Disorders. Condition 3: Severe Psychiatric Disorders. Intervention 1: First intervention group: Patients with severe psychiatric disorders (bipolar, schizophrenia, and schizoaffective). Intervention 2: Second intervention group: Caregivers of patients with severe psychiatric disorders (bipolar, schizophrenia, and schizoaffective). Intervention 3: First control group: Patients with severe psychiatric disorders (bipolar, schizophrenia, and schizoaffective). Intervention 4: Second control group: caregivers of patients with severe psychiatric disorders (bipolar, schizophrenia, and schizoaffective). No - There is not a plan to make this available Justification or reason for not sharing IPD is In order to maintain maximum confidentiality of patient information
public Dr.Rahim Badrfam
Takhti Street, 45-meter Kaj Boulevard - Azimieh
Karaj Iran (Islamic Republic of) 3174838711 +98 26 3255 1444 rbadrfam@gmail.com Alborz University of Medical Sciences scientific Rahim Badrfam
Mahdasht,Shariati Hospital
Karaj Iran (Islamic Republic of) 3139865787 +98 26 3251 5858 rbadrfam@gmail.com Alborz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis confirmed by two psychiatrists based on DSM-5-TR "Stable" mental status (operational definition: PANSS score below threshold Age between 18 and 65 years Informed consent 18 years 65 years Both Absence of more than 2 sessions of the intervention Exacerbation of the severity of the disease symptoms requiring immediate hospitalization Intention to withdraw from the study at any stage F20 F31 F25 Schizophrenia Bipolar disorder Schizoaffective disorders Treatment - Other Treatment - Other Placebo Placebo First intervention group: Patients with severe psychiatric disorders (bipolar, schizophrenia, and schizoaffective) Second intervention group: Caregivers of patients with severe psychiatric disorders (bipolar, schizophrenia, and schizoaffective) First control group: Patients with severe psychiatric disorders (bipolar, schizophrenia, and schizoaffective) Second control group: caregivers of patients with severe psychiatric disorders (bipolar, schizophrenia, and schizoaffective) Depression score on the Beck Depression Inventory. Timepoint: Score measurement of depression at the beginning of the study (before the intervention) and at weeks 6, 8, 10, and 18 after the start of group cognitive-behavioral therapy. Method of measurement: Beck Depression Inventory. Beck Anxiety Inventory score. Timepoint: Score measurement of anxiety at the beginning of the study (before the intervention) and at weeks 6, 8, 10, and 18 after the start of group cognitive-behavioral therapy. Method of measurement: Beck Anxiety Inventory. Beck suicide score. Timepoint: Score measurement f suicide at the beginning of the study (before the intervention) and at weeks 6, 8, 10, and 18 after the start of group cognitive-behavioral therapy. Method of measurement: Beck Suicide Questionnaire. Stigma Score at World Psychiatric Organization Stigma Questionnaire. Timepoint: Score measurement of stigma at the beginning of the study (before the intervention) and at weeks 6, 8, 10, and 18 after the start of group cognitive-behavioral therapy. Method of measurement: World Psychiatric Organization Stigma Questionnaire. Social Capital Score at Nahapit and Ghoshal Questionnaire. Timepoint: Score measurement of Social Capital at the beginning of the study (before the intervention) and at weeks 6, 8, 10, and 18 after the start of group cognitive-behavioral therapy. Method of measurement: Social Capital Questionnaire Nahapit and Ghoshal Questionnaire. Quality of life score on the quality of life questionnaire. Timepoint: Score measurement of quality of life at the beginning of the study (before the intervention) and at weeks 6, 8, 10, and 18 after the start of group cognitive-behavioral therapy. Method of measurement: Quality of life questionnaire. Alborz University of Medical Sciences Approved 2025-11-08 Research Ethics Committees of Alborz University of Medical Sciences Mohammadshahr to Mahdasht Road, Baghestan Boulevard Karaj Alborz Iran (Islamic Republic of)