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IRCT20220127053841N1 IRCT 2022-04-18 Islamic Azad University Effect of Integrated Schema Therapy and Mindfulness on Improving Psychological Symptoms in Caregiving Patients with Dementia Comparison of the Effectiveness of Integrated Schema Therapy and Mindfulness, Emotion Efficacy Therapy and Caregiver base Mindfulness Therapy on Entrapment, Guilt, Burden, Compassion Fatigue and Sense of Competence in Caregiving Patients with Dementia 2022-05-05 anticipated 72 Complete https://irct.ir/trial/61576 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The purpose of random allocation is that the clinician can not predict the treatment of the disease. Random allocation of the type of treatment or allocation random heart is the study of a clinical trial. The samples will be identified by random blocking method and using random number table, Random Allocation Software software. Block: This method is used to prevent significant imbalances in the number of participants assigned to each group.Block randomization ensures that no significant imbalances occur between groups during randomization. At certain points, the number of participants in each group is equal.For this method, the size of each block must first be specified (for example, a block of four), then write a list of blocks and assign numbers to them (AABB (1) -ABAB (2) -ABBA (3) -BBAA (4) -BABA (5) - BAAB (6)), then select random numbers between one to 6 (for example 1, 4, 5, etc.) and finally specify the treatment allocation list based on previous random numbers (… AABB-BBAA-BABA-) , Will be intervened in four groups including three groups and one control group, Blinding description: Participants, or in other words, people who have been invited to participate in the study and after obtaining informed consent have been classified into intervention groups, may not know the main purpose of the study, these people only know that in a study They participate, which will lead to the improvement of their psychological problems, and they are only unaware of the allocation of groups. The statistical analyst does not know the content of the treatment sessions, but the hypotheses, goals, and study questions. N/A Dementia. Intervention 1: Intervention group1:Intervention (package therapy) mindfulness and schema therapy (van Vreeswijk,M.,Broersen,J.,&Schurink (2014) This program has 8 training sessions and two follow-up sessions ‌‌Messages once a week for one and a half hours. Session 1:Schemas, mindsets and mindfulness training-Introduction-Explanation-Practice-Homework Session 2: Conscious attention to the environment-Breathing-Sounds-Physical feelings-Thoughts-Emotions-Released consciousness-Homework Session 3: Conscious attention to breathing- Painful Memories - Walking - Three-Minute Breathing Space - Homework Session 4:Conscious Attention to Schema Coping (Coping with Problems) - Conscious Attention to Schemas - Familiarity with Schemas - Confectionery -Conscious Attention - Homework Session 5:Permission and Acceptance of everything that exists (reaction in the form of great mentalities Healthy year and happy child-Interactive conscious attention interaction with loved ones) -Conscious three-minute conscious attention to the schema-Accepting the conscious attention of oneself and others-Homework Session 6:Plans-‌‌ Reality or fantasy Conscious attention to walking-Leaving the schemes to themselves-Homework Session 7:Taking care of yourself through a healthy adult and happy child-Conscious attention to healthy adults and happy children-Preparing for the future-Needs of healthy adults and happy children-Conscious attention to schemas حکم as pure thoughts-Homework Session 8 :Future - Schemas and mentalities in the future - Conscious attention to yourself as a child and adult - Stunt combined with awareness of schema and mentality in individual interactions Two follow-up sessions: 1 - one month after treatment and 2 - two months later - time Shorter - Emphasis on maintaining and improving previously acquired skills. Intervention 2: Intervention group 2:Intervention (treatment package) Emotional efficiency (McKay and West (2016)) This program has 8 training sessions and two follow-up sessions ‌‌Messages once a week for one and a half hours. Session 1:Observation and acceptance: ‌Awareness of excitement Session 2:Conscious mind acceptance: ‌Wave riding on excitement Session 3: Value-Based Action - Part One Session 4: Value-Based Action - Part II Session 5: ‌‌Conscious Mind Coping: ‌‌‌Loneliness and self-relaxation Session 6:Conscious mind confrontation: مقControversial thoughts and fundamental acceptance Session 7:Conscious mind confrontation: ‌Return attention and rest time Session 8: ‌ Fixation, unwind and summarizing. Intervention 3: Intervention group 3: intervention (treatment package) mindfulness of the caregiver of Rezek(2015) This program has 8 training sessions and two follow-up sessions. Meetings last once a week for an hour and a half. Session 1: Introduction to mindfulness for caregivers - Explain the course and how the mind and body interact against stress -Training body postures in mindfulness exercises (sitting and lying down) Session 2:Breathing practice training (5 minutes) for caregivers ‌‌ ‌‌ Mindfulness training training ‌‌ Conscious care for caregivers Introductory mind training training for caregivers Session 3:Breathing training training (relaxing moments in less than 2 minutes) -Shower training training ‌‌Conscious mind-training-Focusing training training (30 minutes) -Homework Session 4:Breathing practice training (5 minutes) for caregivers - Mountain meditation practice training for caregivers - Mindfulness training training for special caregivers thoughts - Homework Session 5:Breathing training training (relaxation moments in less than 2 minutes) - Training to choose to change the focus of caregivers as a solution to deal with unpleasant thoughts and emotions - Homework Session 6:Breathing training training (5 minutes) for caregivers - Training training for body posture training for caregivers - Training training for self-care for caregivers - Training training for setting boundaries along with the volume of work for caregivers - Homework: Special caregivers' body posture - Special caregivers' self-care exercise - Boundaries exercise along with the volume of caregivers' workload Session 7:Breathing training training (relaxing moments in less than 2 minutes) - Training training ‌‌ Mindful walking-Conscious training training ‌‌ Mindfulness training for caregivers, Homework Session 8:Breathing training training (5 minutes) for caregivers - Limiting exercises along with the volume of work for caregivers - Teaching strategies to deal with resistance to exercise - Homework. Intervention 4: Control group: A group that is not subject to any intervention. They only complete the questionnaires before and after reading. If they wish, they can intervene after the end of the study. Yes - There is a plan to make this available What will be shared: Participant data file only in general and without mentioning the name and address of the participants (number-gender-age-education). The study protocol can also be published as a table. The statistical analysis map can be published in the form of tables and statistical results. The informed consent can be published in full. The results of applied research can be published. Statistical methods and statistical analysis can be published. The obtained data can be published in the form of tables. All of the above can be provided to participants in accordance with the instructions of the journals and in case of no damage. When: The start of the access period is with the opinion and agreement of the relevant journals. To whom: It will be accessible to all people who have access to authoritative sources for publishing articles such as reputable journals and the results of this research can be used for them. Conditions: All cases of using the documents will be possible with the permission of the university of study and professors related to the research and in compliance with the existing rules and regulations. Where to obtain: Reputable journals in which research-related articles are published. The e-mails of the supervisors, advisors and students implementing the project and their university website will be provided to the applicants using the results in accordance with the rules and regulations and maintaining the confidentiality of the participants. How to obtain: Applicable requests will be answered as soon as possible if the rules related to research documents are observed. Comments: All of the above can be done within the framework of the rules and regulations of research and publication in relevant journals and universities. If a case is not within the scope of these laws, it will not be published. A special case is to maintain the confidentiality of participants' information and not to harm them.
public Nahid Ramezani
No5, Banafsheh Allye, Arasteh Alley(35), West Nazar
Esfahan Iran (Islamic Republic of) 8175646391 +98 31 3629 1196 mnahidramezanii@yahoo.com Islamic Azad University scientific Nahid Ramezani
No5, Banafsheh Allye, Arasteh Alley(35), West Nazar
Esfahan Iran (Islamic Republic of) 8175646391 +98 31 3629 1196 mnahidramezanii@yahoo.com Islamic Azad University Iran (Islamic Republic of) Possible diagnosis of patients (recipients of care) with the diagnosis of a specialist doctor, or a short mental state test, which indicates moderate or severe cognitive impairment of patients At least one restriction on the activities of daily living, or at least two dependencies on the instrumental activities of the patients's daily life Being 30 years old and older Taking care of a relative with dementia for at least 6 months, at least four hours a day Not being under psychiatric and psychological treatments Achieving a moderate to high level of depression, anxiety and stress in the DOS questionnaire (25-40) 30 years no limit Both Having two sessions of absence in the intervention process Having cognitive, physical, sensory or language barriers that may prevent participation in the study Receiving psychological treatment Having previous experience in the therapies used in the research Age less than 30 years F03 Unspecified dementia Lifestyle Lifestyle Lifestyle Lifestyle Intervention group1:Intervention (package therapy) mindfulness and schema therapy (van Vreeswijk,M.,Broersen,J.,&Schurink (2014) This program has 8 training sessions and two follow-up sessions ‌‌Messages once a week for one and a half hours. Session 1:Schemas, mindsets and mindfulness training-Introduction-Explanation-Practice-Homework Session 2: Conscious attention to the environment-Breathing-Sounds-Physical feelings-Thoughts-Emotions-Released consciousness-Homework Session 3: Conscious attention to breathing- Painful Memories - Walking - Three-Minute Breathing Space - Homework Session 4:Conscious Attention to Schema Coping (Coping with Problems) - Conscious Attention to Schemas - Familiarity with Schemas - Confectionery -Conscious Attention - Homework Session 5:Permission and Acceptance of everything that exists (reaction in the form of great mentalities Healthy year and happy child-Interactive conscious attention interaction with loved ones) -Conscious three-minute conscious attention to the schema-Accepting the conscious attention of oneself and others-Homework Session 6:Plans-‌‌ Reality or fantasy Conscious attention to walking-Leaving the schemes to themselves-Homework Session 7:Taking care of yourself through a healthy adult and happy child-Conscious attention to healthy adults and happy children-Preparing for the future-Needs of healthy adults and happy children-Conscious attention to schemas حکم as pure thoughts-Homework Session 8 :Future - Schemas and mentalities in the future - Conscious attention to yourself as a child and adult - Stunt combined with awareness of schema and mentality in individual interactions Two follow-up sessions: 1 - one month after treatment and 2 - two months later - time Shorter - Emphasis on maintaining and improving previously acquired skills Intervention group 2:Intervention (treatment package) Emotional efficiency (McKay and West (2016)) This program has 8 training sessions and two follow-up sessions ‌‌Messages once a week for one and a half hours. Session 1:Observation and acceptance: ‌Awareness of excitement Session 2:Conscious mind acceptance: ‌Wave riding on excitement Session 3: Value-Based Action - Part One Session 4: Value-Based Action - Part II Session 5: ‌‌Conscious Mind Coping: ‌‌‌Loneliness and self-relaxation Session 6:Conscious mind confrontation: مقControversial thoughts and fundamental acceptance Session 7:Conscious mind confrontation: ‌Return attention and rest time Session 8: ‌ Fixation, unwind and summarizing Intervention group 3: intervention (treatment package) mindfulness of the caregiver of Rezek(2015) This program has 8 training sessions and two follow-up sessions. Meetings last once a week for an hour and a half. Session 1: Introduction to mindfulness for caregivers - Explain the course and how the mind and body interact against stress -Training body postures in mindfulness exercises (sitting and lying down) Session 2:Breathing practice training (5 minutes) for caregivers ‌‌ ‌‌ Mindfulness training training ‌‌ Conscious care for caregivers Introductory mind training training for caregivers Session 3:Breathing training training (relaxing moments in less than 2 minutes) -Shower training training ‌‌Conscious mind-training-Focusing training training (30 minutes) -Homework Session 4:Breathing practice training (5 minutes) for caregivers - Mountain meditation practice training for caregivers - Mindfulness training training for special caregivers thoughts - Homework Session 5:Breathing training training (relaxation moments in less than 2 minutes) - Training to choose to change the focus of caregivers as a solution to deal with unpleasant thoughts and emotions - Homework Session 6:Breathing training training (5 minutes) for caregivers - Training training for body posture training for caregivers - Training training for self-care for caregivers - Training training for setting boundaries along with the volume of work for caregivers - Homework: Special caregivers' body posture - Special caregivers' self-care exercise - Boundaries exercise along with the volume of caregivers' workload Session 7:Breathing training training (relaxing moments in less than 2 minutes) - Training training ‌‌ Mindful walking-Conscious training training ‌‌ Mindfulness training for caregivers, Homework Session 8:Breathing training training (5 minutes) for caregivers - Limiting exercises along with the volume of work for caregivers - Teaching strategies to deal with resistance to exercise - Homework Control group: A group that is not subject to any intervention. They only complete the questionnaires before and after reading. If they wish, they can intervene after the end of the study. Entrapment is a special type of thinking and feeling that refers to trapping or trapping a person in a situation that he wants to avoid. Entrapment as a forced cessation of human activity and the inability of the individual to escape from the situation. Timepoint: At the beginning of the study, after the intervention and three months after the intervention. Method of measurement: Gilbert and Allen Entrapment(Failure)Questionnaire. Guilty score in the questionnaire of Losada et al., Which includes ‌guilt about doing wrong by the care recipient,guilt about not rising to the occasion as caregivers, guilt about self-care, guilt about neglecting other relatives,and guilt about having negative feelings towards other people. Timepoint: At the beginning of the study, after the intervention and three months after the intervention. Method of measurement: The CaregiverGuilt Questionnaire of Losada et al(2010). The burden of care includes personal, social, emotional and economic pressures. Timepoint: At the beginning of the study, after the intervention and three months after the intervention. Method of measurement: Caregiver's burden questionnaire. Compassion fatigue ("compassionate" "a state of fatigue and dysfunction (biological, psychological, and social) that results from prolonged exposure to the stress of compassion"; Caregivers are exposed to the suffering of their patients or are too emotional. Timepoint: At the beginning of the study, after the intervention and three months after the intervention. Method of measurement: Vocational life quality Stam. A sense of competence expresses caregivers' feelings about their ability to care for a patient. Timepoint: At the beginning of the study, after the intervention and three months after the intervention. Method of measurement: Sense of competence questionnaire. Islamic Azad University Isfahan (Khorasgan) Branch. Approved 2022-02-22 Ethics Committee of Islamic Azad University, Isfahan Branch (Khorasgan) No. 5, Banafshe Alley, Arasteh Alley(35), Nazar Gharbi St. Isfahan Isfehan Iran (Islamic Republic of)