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IRCT20201219049755N1 IRCT 2021-04-11 Zahedan University of Medical Sciences Effectiveness of Integrated Treatment of Family Focused Therapy (FFT) and Social Cognition and Interaction Training (SCIT) In Patients with Bipolar Type 1 Evaluation of The Effect of Integrated Treatment of Family Focused Therapy (FFT) and Social Cognition and Interaction Training (SCIT) on the Signs and Symptoms, Interpersonal Relationships, Relapse and Quality of Life among Patients with Bipolar Type 1 and study of the effective elements of these two therapeutic approaches. 2021-04-14 anticipated 75 Complete https://irct.ir/trial/54454 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Other design features: This study included a review of the combined effectiveness of the two treatments. In family-centered therapy, the presence of the patient's primary caregiver is essential for education. But the treatment of social cognition and interaction training will be only on patients. to evaluate the effective elements of the two therapies will be used of researcher-made checklists that will be completed by a researcher colleague of the patient's family members. Based on this, we will develop an integrated protocol according to the effective components of the two treatments in accordance with Iranian culture, Randomization description: The method of random allocation will be drawing a number as a lottery container containing 25 balls for the experimental group 1, 25 balls for the experimental group 2 and 25 balls for the control group. Then the balls will be randomly taken out without replacement from the container and the sequence will be written on a piece of paper. The first number will be assigned to experimental group 1, the second one to experimental group 2 and the third one to control group, and this process will be continued until the last number.Allocation concealment will be also done only in data analysis. N/A Bipolar disorder type 1. Intervention 1: Intervention group 1: This group ,in addition to receiving medication, will be received 15 sessions of family-focused treatment with their primary caregivers twice a week. After the Completion of the intervention and a 2 week wash out period, patients will be received social cognition and interaction training twice a week. Intervention 2: Intervention group 2: This group ,in addition to medication, will be received 15 sessions of social cognition and interaction training twice a week. After Completion of the intervention and 2-week wash out period, patients will be received family-focused treatment twice a week with their primary caregiver. Intervention 3: Control group: This group will be received medication. Yes - There is a plan to make this available What will be shared: Information of primary and secondary consequences will be shared. When: 3 months after the results are published. To whom: Academic institutions Conditions: people intend to repeat the protocol in psychiatric hospitals. Where to obtain: By email address: ma.yosefi@uswr.ac.ir How to obtain: 2 to 3 months Comments:
public Maryam Yosefi Tabas
Department of Psychology; University of Social Welfare and Rehabilitation Sciences; Kodakyar avenue; Daneshjo boulevard; Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0045 ymary9940@gmail.com University of social welfare and rehabilitation sciences scientific Fereshte Momeni
Department of Psychology; University of Social Welfare and Rehabilitation Sciences; Kodakyar avenue; Daneshjo boulevard; Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0045 momenipsy@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Bipolar disorder type 1 has been diagnosed by a psychiatrist Having a score between 14 -18 in the Cognitive complaints in bipolar disorder rating assessment (COBRA) Don't having more than 3 recurrences At least had a high school education Having a score below 9 had in the Young Mania Scale Consent must be Obtained from patient's primary caregiver for participating in the study 18 years 45 years Both Had a history of alcohol and substance abuse. Had a history of brain injury. Had a mental disorder other than the main diagnosis. Had a severe personality disorder (diagnosed by a psychiatrist) Had simultaneous visits to psychological clinics for psychological treatment. F31.77 Bipolar disorder, in partial remission, most recent episode mixed Prevention Rehabilitation Prevention Intervention group 1: This group ,in addition to receiving medication, will be received 15 sessions of family-focused treatment with their primary caregivers twice a week. After the Completion of the intervention and a 2 week wash out period, patients will be received social cognition and interaction training twice a week. Intervention group 2: This group ,in addition to medication, will be received 15 sessions of social cognition and interaction training twice a week. After Completion of the intervention and 2-week wash out period, patients will be received family-focused treatment twice a week with their primary caregiver. Control group: This group will be received medication. Score of depression in Beck Depression Inventory. Timepoint: Before the intervention, after the completion of the first intervention, after the completion of the second intervention, follow-up. Method of measurement: Beck Depression Inventory. Score of quality of life of patients in Quality of Life Questionnaire. Timepoint: Before intervention, after completion of the first intervention, after completion of the second intervention, follow-up. Method of measurement: Quality of Life Questionnaire (WHO-QOL-BREF). Score of mania in Young Mania Questionnaire. Timepoint: Before the intervention, after the completion of the first intervention, after the completion of the second intervention, follow-up. Method of measurement: Young Mania Questionnaire. Score of Interpersonal relations in social performance questionnaire. Timepoint: Before the intervention, after the completion of the first intervention, after the completion of the second intervention, follow-up. Method of measurement: social performance questionnaire. Relapse. Timepoint: Before intervention, after completion of the first intervention, after completion of the second intervention, follow-up. Method of measurement: scores above 20 in the Beck Depression and Young Mania Inventory. Social performance. Timepoint: Before intervention, after completion of the first intervention, after completion of the second intervention, follow-up. Method of measurement: Social Performance Questionnaire. Zahedan University of Medical Sciences Approved 2020-01-14 Ethics committee of Tehran University of Social Welfare and Rehabilitation Science Kodakyar Ave, Daneshjo Blvd, Evin Tehran Tehran Iran (Islamic Republic of)