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IRCT20181128041778N1 IRCT 2019-04-20 Kashan University of Medical Sciences Effect of Mindfulness-based stress reduction and Cognitive behavior Therapy in Rheumatoid Arthritis Patients Effect of Mindfulness-based stress reduction and Cognitive behavior Therapy on Emotional Strategies, Executive function, Activity of disease, quality of life and sleep in Rheumatoid Arthritis Patients 2018-11-22 anticipated 75 Complete https://irct.ir/trial/35779 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Regarding the classification of patients with rheumatoid arthritis in grade 3, patients will be included in the study of the severity of rheumatoid arthritis due to the active status of the disease and the first and second grades, Randomization description: 75 patients are randomly selected for rheumatoid arthritis. Subsequently, they are randomly divided into three groups (MBSR intervention, CBT, control) of 25 people, Blinding description: In this study, after the participants are selected, we begin the treatment randomly without knowing what other interventions are in other groups, but the treatment that will be applied to them will be explained. The participants' The treatment is that they do not know that there is another treatment group and another treatment. But after the end of the treatment, we will find out about the rest of the treatments and they will be treated if they are willing to treat them. The right to which group What treatments apply is knowledgeable. N/A Rheumatoid Arthritis. Intervention 1: Intervention group: MBSR : Therapeutic intervention is an 8 session that lasts once a week for 90 minutes, during which participants are taught to communicate at an instant, without judgment, with full attention and awareness to the world inside and outside. This approach comes in line with the CABAT Zein treatment protocol (2013). Intervention 2: Intervention group: CBT In this research, cognitive-behavioral therapy education is a cognitive-behavioral group method that is provided by the researcher based on therapeutic packages available in this area during 11 sessions of 60 minutes to modify the mental, emotional and behavioral patterns of the members. To be Additionally, being in the group, members can use the feedback from others and decide on the changes they want to do. That is, members can compare their own perceptions of their own with the perceptions of others and then decide what they can do with this information. Intervention 3: Control group: The control group is the same group that does not receive any treatment except its medication. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public shafigheh Yousefi
Shahid Beheshti Hospital, Kashan University of Medical Sciences
kashan Iran (Islamic Republic of) 8115187159 +98 31 5562 0634 sh.yusefi2012@yahoo.com Kashan University of Medical Sciences scientific shafigheh yousefi
Shahid Beheshti Hospital, Kashan University of Medical Sciences
kashan Iran (Islamic Republic of) 8115187159 +98 31 5562 0634 sh.yusefi2012|@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of RA with arthritis At least six months have passed since the diagnosis of rheumatoid arthritis Age of 18 to 60 years Minimum Cycle Education Diagnosis of other joints 18 years 60 years Both There is another joint disease Drug Addiction Suicidal ideation or suicidal thoughts Abuse of alcohol Absence of more than one session in the treatment of MBSR There are more than two sessions in the treatment of CBT M06.9 Rheumatoid arthritis, unspecified Behavior Behavior Other Intervention group: MBSR : Therapeutic intervention is an 8 session that lasts once a week for 90 minutes, during which participants are taught to communicate at an instant, without judgment, with full attention and awareness to the world inside and outside. This approach comes in line with the CABAT Zein treatment protocol (2013). Intervention group: CBT In this research, cognitive-behavioral therapy education is a cognitive-behavioral group method that is provided by the researcher based on therapeutic packages available in this area during 11 sessions of 60 minutes to modify the mental, emotional and behavioral patterns of the members. To be Additionally, being in the group, members can use the feedback from others and decide on the changes they want to do. That is, members can compare their own perceptions of their own with the perceptions of others and then decide what they can do with this information. Control group: The control group is the same group that does not receive any treatment except its medication. Stress. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: DASS-21. Depression. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: DASS-21. Anxiety. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: DASS-21. Chronic fatigue. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: Chronic fatigue syndrome (CFS). Sleep Quality. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI). Quality of life. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: Short Form Health Survey (SF-36). Executive functions. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: Tower of London test. Disease activity. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: blood test. Kashan University of Medical Sciences Approved 2018-11-05 Ethical Committee of Kashan University of Medical Sciences Ethics Committee of Kashan University of Medical Sciences, Ghotb Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)