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IRCT20201006048952N1 IRCT 2021-03-06 Esfahan University of Medical Sciences Effectiveness of Mindfulness on cognitive and emotional factors in Systemic Lupus Erythematosus Patients Effectiveness of Mindfulness-Based Stress Reduction(MBSR) on illness perception, illness acceptance, difficulties with emotion regulation and cognitive flexibility in Systemic Lupus Erythematosus Patients 2021-04-03 anticipated 20 Complete https://irct.ir/trial/53819 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance. N/A Systemic Lupus Erythematosus. Intervention 1: The standard mindfulness-based stress reduction treatment (MBSR) protocol will be used to educate patients. This protocol includes 8 sessions of mindfulness-based stress reduction therapy, each of which regularly and separately includes the complete content as follows: Instructional videos for the therapist (theoretical concepts to be taught to patients along with instruction on how to Presenting materials, explanations and examples), therapist training booklets, client training booklets, teaching mindfulness techniques (formal and informal exercises), audio files of techniques and worksheets for clients' homework. In each treatment session, the researcher will provide theoretical basics for patients. In the first to fifth sessions, after presenting the theoretical concepts, a practical mindfulness technique related to the same theoretical concepts will be taught to the clients to better understand the content. And they are asked to do the technique in the meeting. Formal and informal exercise training will then be provided, and patients should complete one round of formal exercise per session. Doing both formal and informal exercises will be part of your homework for next week. The training booklets provided by the treatment protocol for learning and educating clients at home are translated, compiled and compiled for clients under the title of "Home Learning Booklet" for clients and presented to them each session along with homework worksheets. will be. Worksheets include tables where clients should record formal and informal mindfulness exercises and the types of meditations they perform at home on a weekly basis and bring them to the next session. Intervention 2: Control group: The standard mindfulness-based stress reduction treatment (MBSR) protocol will be used to educate patients. This protocol includes 8 sessions of mindfulness-based stress reduction therapy, each of which regularly and separately includes the complete content as follows: Instructional videos for the therapist (theoretical concepts to be taught to patients along with instruction on how to Presenting materials, explanations and examples), therapist training booklets, client training booklets, teaching mindfulness techniques (formal and informal exercises), audio files of techniques and worksheets for clients' homework. In each treatment session, the researcher will provide theoretical basics for patients. In the first to fifth sessions, after presenting the theoretical concepts, a practical mindfulness technique related to the same theoretical concepts will be taught to the clients to better understand the content. And they are asked to do the technique in the meeting. Formal and informal exercise training will then be provided, and patients should complete one round of formal exercise per session. Doing both formal and informal exercises will be part of your homework for next week. The training booklets provided by the treatment protocol for learning and educating clients at home are translated, compiled and compiled for clients under the title of "Home Learning Booklet" for clients and presented to them each session along with homework worksheets. will be. Worksheets include tables where clients should record formal and informal mindfulness exercises and the types of meditations they perform at home on a weekly basis and bring them to the next session. No - There is not a plan to make this available Justification or reason for not sharing IPD is This file will not be published because it contains personal and private information of the participants.
public Shirin Irani
No.139 - Ferdowsi Allay , Sheikhbahaiy St.
Isfahan Iran (Islamic Republic of) 8134816515 +98 31 3233 3860 s.irani@edu.ac.ir University of Isfahan scientific Shirin Irani
No. 139,Ferdowsi Allay , Sheikhbahaiy St.
Isfahan Iran (Islamic Republic of) 8134816515 009832333860 s.irani@edu.ui.ac.ir University of Isfahan Iran (Islamic Republic of) A minimum of 6 months and a maximum of 3 years have elapsed since the diagnosis of Systemic Lupus Erythematosus Do not have another physical illness at the same time No concomitant psychiatric disorders Do not take any other medicines (except medicines used to treat lupus) Minimum diploma education Score less than 14 in the Hospital Anxiety and Depression Scale 18 years 65 years Both starting lupus flares M32 Systemic lupus erythematosus (SLE) Behavior Behavior The standard mindfulness-based stress reduction treatment (MBSR) protocol will be used to educate patients. This protocol includes 8 sessions of mindfulness-based stress reduction therapy, each of which regularly and separately includes the complete content as follows: Instructional videos for the therapist (theoretical concepts to be taught to patients along with instruction on how to Presenting materials, explanations and examples), therapist training booklets, client training booklets, teaching mindfulness techniques (formal and informal exercises), audio files of techniques and worksheets for clients' homework. In each treatment session, the researcher will provide theoretical basics for patients. In the first to fifth sessions, after presenting the theoretical concepts, a practical mindfulness technique related to the same theoretical concepts will be taught to the clients to better understand the content. And they are asked to do the technique in the meeting. Formal and informal exercise training will then be provided, and patients should complete one round of formal exercise per session. Doing both formal and informal exercises will be part of your homework for next week. The training booklets provided by the treatment protocol for learning and educating clients at home are translated, compiled and compiled for clients under the title of "Home Learning Booklet" for clients and presented to them each session along with homework worksheets. will be. Worksheets include tables where clients should record formal and informal mindfulness exercises and the types of meditations they perform at home on a weekly basis and bring them to the next session. Control group: The standard mindfulness-based stress reduction treatment (MBSR) protocol will be used to educate patients. This protocol includes 8 sessions of mindfulness-based stress reduction therapy, each of which regularly and separately includes the complete content as follows: Instructional videos for the therapist (theoretical concepts to be taught to patients along with instruction on how to Presenting materials, explanations and examples), therapist training booklets, client training booklets, teaching mindfulness techniques (formal and informal exercises), audio files of techniques and worksheets for clients' homework. In each treatment session, the researcher will provide theoretical basics for patients. In the first to fifth sessions, after presenting the theoretical concepts, a practical mindfulness technique related to the same theoretical concepts will be taught to the clients to better understand the content. And they are asked to do the technique in the meeting. Formal and informal exercise training will then be provided, and patients should complete one round of formal exercise per session. Doing both formal and informal exercises will be part of your homework for next week. The training booklets provided by the treatment protocol for learning and educating clients at home are translated, compiled and compiled for clients under the title of "Home Learning Booklet" for clients and presented to them each session along with homework worksheets. will be. Worksheets include tables where clients should record formal and informal mindfulness exercises and the types of meditations they perform at home on a weekly basis and bring them to the next session. Illness perception. Timepoint: Before intervention, after intervention, follow up. Method of measurement: Brief Illness Perception Questionnaire(BIPQ). Illness acceptance. Timepoint: Before intervention, after intervention, follow up. Method of measurement: Chronic Illness Acceptance Questionnaire (CIAQ). Difficulties with emotion regulation. Timepoint: Before intervention, after intervention, follow up. Method of measurement: Difficulties in Emotion Regulation Scale. Cognitive flexibility. Timepoint: Before intervention, after intervention, follow up. Method of measurement: Cognitive Flexibility Inventory (CFI). Clinical characteristics of systemic lupus erythematosus patients. Timepoint: Pretest, Post test and follow up. Method of measurement: Blood test, Clinical examinations, Systemic Lupus Erythematosus Disease Activity Index. Shirin Irani Approved 2021-01-13 Ethics commettee of University of Isfahan Hezar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)