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IRCT20161010030255N4 IRCT 2020-12-18 Esfahan University of Medical Sciences A comparison of the effect of mindfulness-based stress reduction (MBSR) and psychoeducation on coping skills in caregivers of dementia patients referred to a psychiatric clinic in Isfahan A comparison of the effect of mindfulness-based stress reduction (MBSR) and psychoeducation on coping skills in caregivers of dementia patients 2020-09-10 anticipated 90 Complete https://irct.ir/trial/51955 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Participants were randomized using a list of computer-generated numbers, and the group assignments were concealed in an opaque sealed envelope until just before entry into the study. A total of 115consecutive patients with dementia were eligible for the study. 25 patients were excluded because they refused entry or did not meet the inclusion criteria. The 90 participants were assigned randomly and equally to one of the two training groups. The first training group received MBSR for 8 weeks. The second group received PE training during the first 8 weeks of the study. At enrolment, all careers had a pre-training evaluation that consisted of demographic data, complete medical history, physical and psychiatric examination. N/A Dementia. Intervention 1: Intervention group: (Psychoeducation), Week 1 educational Presentations / What is Dementia? / Multi-sensory stimulation strategies: Olfaction Supportive Emotional impact on caregiving / Relaxation: Abdominal breathing Week 2 teaching/educating on Communication in Dementia; Multi-sensory stimulation strategies: Contact Supportive Deal with emotions / Relaxation: Stretching Week 3: teaching Multi-sensory stimulation strategies: Vision-Supportive Assertiveness / Relaxation: Guided imagery (purposeful/targeted pictures?)week 4: training/teaching/learning Multi-sensory stimulation strategies: Hearing- Social support (community support) /Relaxation: Progressive muscle relaxation technique Week5: teaching Multi-sensory stimulation strategies: Taste, Supportive Self-care / Relaxation: Autogenic technique week 6: teaching Elderly engagement: impossible mission? Supportive Problem-solving / Relaxation: Week7: Mitchell method teaching Challenging behaviors: How to cope with …? Supportive Cope with overcoming grief / Relaxation: Progressive muscle trainingWeek8: training to have a safer environment: What can we do? Celebration and closing session. Intervention 2: Intervention group, mindfulness: mindfulness, learning context for the rest of the experience. learning the theory and evidence of (medical/practitioner self/body-conscious) mind-body medicine and how to apply it. Introducing mindful (conscious) eating, mindful breathing, and the body-scanning method, focusing on what it means to be fully engaged in the present moment/current situation. week 2 learn to use the Body-scanning method to increase awareness about stress reactions. influencing the way someone perceives and responds to problems and challenges. The short- and long-term effects of stress on the individual mind and body. WEEK 3 practice several distinct and yet interrelated mindfulness methods, sitting meditation, and walking meditation. Investigate the process of expressing feelings like joy/pleasure or discomfort in mind and body.WEEK 4 the focus of the session is on the development of the ability to concentrate and expanding awareness systematically. learning the physiological and psychological bases of stress reactions (reactions under stress), and learning mindful strategies for positive and proactive respond in stressful situations.WEEK 5 pay attention to the places (situation) where you might get stuck in repetitive, unhealthy patterns that can (be managed) disarm through (by having) mindful awareness. Learn how to use mindfulness in a critical moment (situation) when we experience a physical sensation, intense emotion, or condition, using the method focus on exploring the effect of reactivity on individuals’ health and illness week 6 focus on transformational coping strategies to develop your inner resources and enhance flexibility using mindfulness practices. Learning the principles of interpersonal mindfulness—using (self/situational?) awareness and presence at times when interactions become difficult or are involved in strong emotions...WEEK 7 explore various ways to fully integrate mindfulness and bring a broader sense of awareness and presence into every moment in life and use non-judgmental mindfulness in self-reflection and decision-making processes.WEEK 8 A comprehensive review on all the content learned in this course; the final (session) lesson is to create a satisfying closure by honoring (celebrating) both the end of this program and the beginning of the rest of life. Yes - There is a plan to make this available What will be shared: All collected information/ data can be shared with other researchers after coding and deidentifying participants’ personal information. When: Start of the program; 6 months after the results are published in the valid journal To whom: Participants and researchers involved in this research and the scientific committee related to this research at the university Conditions: In order to maintain confidentiality requirements, the data will not be made available to others except those that the university committees will request for scientific evaluation validity and reliability tests and revaluation Where to obtain: If the data is needed by the abovementioned groups, they can contact the (chief officer )main executor of the project How to obtain: Contact the Vice-Chancellor for Research and then contact the executor of the main project chief officer Comments:
public Victoria Omranifard
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 v_omranifard@med.mui.ac.ir Esfahan University of Medical Sciences scientific Victoria Omranifard
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 v_omranifard@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) First (direct) caregiver of the Dementia patient The age between 18-60. Reading and writing ability lack of cognitive impairments Ability to attending in the treatment sessions lack of physical problems affecting their mental state, Informed consent. 18 years 60 years Both Participants should not require any medical treatment (i.e., pharmacological and non-pharmacological) between sessions Absence for more than two sessions Severe depression, psychosis, schizophrenia, bipolar disorder, or mental retardation Drug addiction. ( that will be verified by the information available in the case file and interview) F00 Alzheimer disease is a primary degenerative cerebral disease of unknown etiology with characteristic neuropathological and neurochemical features. The disorder is usually insidious in onset and develops slowly but steadily over a period of several years. Behavior Behavior Intervention group: (Psychoeducation), Week 1 educational Presentations / What is Dementia? / Multi-sensory stimulation strategies: Olfaction Supportive Emotional impact on caregiving / Relaxation: Abdominal breathing Week 2 teaching/educating on Communication in Dementia; Multi-sensory stimulation strategies: Contact Supportive Deal with emotions / Relaxation: Stretching Week 3: teaching Multi-sensory stimulation strategies: Vision-Supportive Assertiveness / Relaxation: Guided imagery (purposeful/targeted pictures?)week 4: training/teaching/learning Multi-sensory stimulation strategies: Hearing- Social support (community support) /Relaxation: Progressive muscle relaxation technique Week5: teaching Multi-sensory stimulation strategies: Taste, Supportive Self-care / Relaxation: Autogenic technique week 6: teaching Elderly engagement: impossible mission? Supportive Problem-solving / Relaxation: Week7: Mitchell method teaching Challenging behaviors: How to cope with …? Supportive Cope with overcoming grief / Relaxation: Progressive muscle trainingWeek8: training to have a safer environment: What can we do? Celebration and closing session Intervention group, mindfulness: mindfulness, learning context for the rest of the experience. learning the theory and evidence of (medical/practitioner self/body-conscious) mind-body medicine and how to apply it. Introducing mindful (conscious) eating, mindful breathing, and the body-scanning method, focusing on what it means to be fully engaged in the present moment/current situation. week 2 learn to use the Body-scanning method to increase awareness about stress reactions. influencing the way someone perceives and responds to problems and challenges. The short- and long-term effects of stress on the individual mind and body. WEEK 3 practice several distinct and yet interrelated mindfulness methods, sitting meditation, and walking meditation. Investigate the process of expressing feelings like joy/pleasure or discomfort in mind and body.WEEK 4 the focus of the session is on the development of the ability to concentrate and expanding awareness systematically. learning the physiological and psychological bases of stress reactions (reactions under stress), and learning mindful strategies for positive and proactive respond in stressful situations.WEEK 5 pay attention to the places (situation) where you might get stuck in repetitive, unhealthy patterns that can (be managed) disarm through (by having) mindful awareness. Learn how to use mindfulness in a critical moment (situation) when we experience a physical sensation, intense emotion, or condition, using the method focus on exploring the effect of reactivity on individuals’ health and illness week 6 focus on transformational coping strategies to develop your inner resources and enhance flexibility using mindfulness practices. Learning the principles of interpersonal mindfulness—using (self/situational?) awareness and presence at times when interactions become difficult or are involved in strong emotions...WEEK 7 explore various ways to fully integrate mindfulness and bring a broader sense of awareness and presence into every moment in life and use non-judgmental mindfulness in self-reflection and decision-making processes.WEEK 8 A comprehensive review on all the content learned in this course; the final (session) lesson is to create a satisfying closure by honoring (celebrating) both the end of this program and the beginning of the rest of life Changes in scores anxiety. Timepoint: Before intervention,after intervention ,after 3 month. Method of measurement: Questionnaire. Change in score of depression. Timepoint: Before intervention,after intervention ,after 3 month. Method of measurement: Questionnaire. Change in quality of life. Timepoint: Before intervention,after intervention ,after 3 month. Method of measurement: Questionnaire. Medical University Approved 2020-09-07 Ethics Committee Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Street, Darvazeh Shiraz, Isfahan Isfahan Isfehan Iran (Islamic Republic of)