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IRCT20190929044918N1 IRCT 2019-11-11 Islamic Azad University The effect of well-being on diabetes بهزیستی درمانی Effect of Well being Therapy on Depression, Anxiety, Self-management and Blood Glucose Control in Women with Type 2 Diabetes 2019-10-21 anticipated 60 Complete https://irct.ir/trial/42590 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocking is used to make balance amongst the samples of each group under examination. This feature might be useful when meso-level analysis is needed during sampling process, so that each group is callocatedthe same amount of samples. In this design randomizing shall take place based on permuted blocking. Thus, paitients will be grouped in 15 blocks, each comprisingtwopeople from the experimental group and two people from the control group.Finally, group 1 will be treated using Well-BeingTherapy(WBT) and the control group shall receive notreatment. N/A Diabetes. Intervention 1: Intervention group:The well-being therapy program for diabetic patients is composed of 12 sessions of 90 minutes held once a week for three months.Early sessions (1-2): Preparing the group, building relationships, and introducing the logic of treatment. Clinical interview, getting identification data, information about feelings, current distress, previous distress, defining the curriculum process, defining the structure and conditions of well-being therapy, including the number of sessions, duration of sessions, interval between sessionsMiddle session (2-6): Identifying existing barriers and removing irrelevant beliefs with the aim of self-observation of care seekers to achieve psychological well-being the role of lack of positive emotions, giving the first home workout, explaining the concept of optimal experiences, describing thoughts and behaviors that are detrimental to well-being, explaining the concept of self-therapy, explaining problem solving, self-acceptance and its role in mental relaxationLast sessions (6-12): Introducing six dimensions of model of psychological well-being and changing six damaged dimensions of psychological well-being. environmental mastery as a component of mental health, initiating cognitive reconstruction of thoughts or behaviors that disrupt well-being, personal growth and exploring social cognitive development, the role of dysfunctional cognitions, providing autonomy components and positive relationships with others, summary, emphasizing the importance of continuing self-therapy after the sessions. Intervention 2: This group receives routine caring actions like glycemic control, medical advice, and prescription of medication from the physician of Diabetes Center. However, it does not receive well-being therapy intervention. 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 I have not yet reviewed which journals to publish
public Mahnaz Pzhuhshgar
No. 2, Behvarz 9, Dr. Hesabi 4, Jam Junc., Daneshgah St.
Mashhad Iran (Islamic Republic of) 91899-14878 +98 51 3866 2507 m.p13978694@gmail.com Islamic Azad University scientific Mahnaz Pazhushgar
No. 2, Behvarz 9, Dr. Hesabi 4, Jam Junc., Daneshgah St.
Mashhad Iran (Islamic Republic of) 9189913878 +98 51 3866 2507 m.p13978694@gmial.com Islamic Azad University Iran (Islamic Republic of) Gender: female Minimum 35 years, maximum 65 years, 3. Depression score of higher than 19 in the 21-item Beck Depression Inventory (BDI-21) .Anxiety score of higher than 16 in the 21-item Beck Anxiety Inventory (BAI-21) Minimum level of Education: high school diploma 35 years 65 years Female Evidence of severe mental disorder (including personality disorder), Other simultaneous psychological and medicinal treatments, Psychiatric medications. N/A N/A Intervention group:The well-being therapy program for diabetic patients is composed of 12 sessions of 90 minutes held once a week for three months.Early sessions (1-2): Preparing the group, building relationships, and introducing the logic of treatment. Clinical interview, getting identification data, information about feelings, current distress, previous distress, defining the curriculum process, defining the structure and conditions of well-being therapy, including the number of sessions, duration of sessions, interval between sessionsMiddle session (2-6): Identifying existing barriers and removing irrelevant beliefs with the aim of self-observation of care seekers to achieve psychological well-being the role of lack of positive emotions, giving the first home workout, explaining the concept of optimal experiences, describing thoughts and behaviors that are detrimental to well-being, explaining the concept of self-therapy, explaining problem solving, self-acceptance and its role in mental relaxationLast sessions (6-12): Introducing six dimensions of model of psychological well-being and changing six damaged dimensions of psychological well-being. environmental mastery as a component of mental health, initiating cognitive reconstruction of thoughts or behaviors that disrupt well-being, personal growth and exploring social cognitive development, the role of dysfunctional cognitions, providing autonomy components and positive relationships with others, summary, emphasizing the importance of continuing self-therapy after the sessions This group receives routine caring actions like glycemic control, medical advice, and prescription of medication from the physician of Diabetes Center. However, it does not receive well-being therapy intervention Depression. Timepoint: At the beginning of the study, both experimental and control groups will be measured before and after the intervention. Method of measurement: Beck Depression Inventory. Anxiety. Timepoint: Both case and control groups are measured at the beginning of the study, before the intervention and after the re-intervention. Method of measurement: Beck Anxiety Inventory. Self-Management. Timepoint: Both case and control groups are measured at the beginning of the study, before the intervention and after the re-intervention. Method of measurement: The Tobert & Thompson Self-Management Questionnaire. Glycemic Control. Timepoint: Both case and control groups are measured at the beginning of the study, before the intervention and after the re-intervention. Method of measurement: Blood sugar test. Islamic Azad University Approved 2019-07-09 National Committee on Ethics in Biomedical Research Boulevard Emamieh 70 Mashhad Razavi Khorasan Iran (Islamic Republic of)